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This study is 25 days long. People participating in this study will be asked to brush their teeth two times a day. People will be assigned to a mouthwash and will rinse four times a day at the site for five days. A dentist or dental hygienist will look at the mouth, teeth, tongue and gums to make sure the mouthwash does not irritate the mouth. After Day 5 of the study, people will continue to brush two times a day and will return on Day 24 to have their mouth looked at again. People without irritation in their mouth will rinse 4 times a day at the clinical site. People will return to the clinical site the next day and have a final oral exam in which the dentist or dental hygienist will look at the mouth for irritation.
This is a randomized, observer-blind, single-center, supervised, controlled, parallel-designed study. Approximately 90 generally healthy adults meeting the necessary inclusion/exclusion criteria will be enrolled so that 78 subjects (26 per treatment group) would reasonably be expected to complete the study. Subjects will have their oral soft/hard tissues assessed at Screening (visit 1), Baseline (visit 2), and Days 3, 5, 24, and 25 (visits 4,6-8). During the first week of the study, subjects will be instructed to brush their teeth for one minute in their usual manner, twice daily using the provided standard fluoride toothpaste. Subjects will return for the Baseline exam and, upon qualification with entry criteria, will be assigned to one of three treatment groups. Qualified subjects will be instructed to return to the site for five consecutive days. Subjects will have four supervised rinses with their assigned mouth rinse for either 30 or 60 seconds using 10 ml or 20 ml, at subsequent one-hour intervals. During the 5 consecutive days of exposure to the assigned mouthrinse, subjects will brush their teeth using the provided fluoride-free toothpaste and soft-bristled toothbrush.
Subjects will then have an 18-day rest period (off treatment). During this time, subjects will follow their usual oral hygiene and dietary habits, using the standard fluoride toothpaste and soft toothbrush provided, and must refrain from using any unassigned oral care products. On the 19th day after completion of Day 5 (Day 24), subjects will return for an oral examination. If no pathology is present, subjects will be given a challenge treatment (four supervised rinses) and the final oral examination will be performed on Day 25.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PO-019 | Experimental | Formula 12027-019 Mouthwash |
|
| PO-020 | Experimental | Formula 12027-020 Mouthwash |
|
| PO-116-A | Active Comparator | Cool Mint Listerine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Potassium Oxalate without Fluoride | Device | 1.40% Potassium Oxalate Sensitive Mouthwash without fluoride - Rinse with 10ml for 60 seconds, four times daily successively at 1 hour intervals for five days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an Abnormal Condition by Anatomical Site at Screening | Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal. | Screening |
| Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Baseline/Pretreatment | Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal. | Day 1 - Baseline/Pretreatment |
| Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Post-treatment | Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal. | Day 1 - Post-treatment |
| Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 3 | Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal. | Day 3 |
| Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 5 | Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Lynch, DMD, PhD | Johnson & Johnson Consumer and Personal Products Worldwide | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Park Research Center (UPRC) | Fort Wayne | Indiana | 46825 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 19292-116-A Control (Listerine®) | Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) |
| FG001 | 12027-019 | 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) |
| FG002 | 12027-020 | 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 19292-116-A Control (Listerine®) | Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) |
| BG001 | 12027-019 | 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With an Abnormal Condition by Anatomical Site at Screening | Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal. | Analysis was based on subjects with measurements for this variable. | Posted | Number | Percentage of Participants | Screening |
|
Day 25, +30 days for serious adverse events.
Adverse events were systematically collected at each study visit through Visit 8 (Day 25). Serious adverse events were reported through 30 days after product use. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 19292-116-A Control (Listerine®) | Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Lynch, DMD, PhD/Study Director | Johnson & Johnson Consumer and Personal Products Worldwide | 908-433-6423 USA EST | mlynch23@its.jnj.com |
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| ID | Term |
|---|---|
| D009912 | Oral Manifestations |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Potassium Oxalate with Fluoride | Device | 1.40% Potassium Oxalate Sensitive Mouthwash with fluoride - Rinse with 20ml for 60 seconds, four times daily successively at 1 hour intervals for five days |
|
|
| Active Comparator PO-116-A | Device | Rinse with comparator mouthwash 20ml for 30 seconds, four times daily successively at 1 hour intervals for five days |
|
|
| Day 5 |
| Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 - Pretreatment | Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal. | Day 24 - Pretreatment |
| Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 - Post-treatment | Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal. | Day 24 - Post-treatment |
| Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 25 | Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal. | Day 25 |
| Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Screening | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Screening |
| Percentage of Subjects in Irritation Score Category for Labial Mucosa at Screening | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Screening |
| Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Screening | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Screening |
| Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Screening | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Screening |
| Percentage of Subjects in Irritation Score Category for Gingiva at Screening | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Screening |
| Percentage of Subjects in Irritation Score Category for Tongue at Screening | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Screening |
| Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Screening | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Screening |
| Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Screening | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Screening |
| Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 1 - Baseline/Pretreatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 1 - Baseline/Pretreatment |
| Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 1 - Baseline/Pretreatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 1 - Baseline/Pretreatment |
| Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 1 - Baseline/Pretreatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 1 - Baseline/Pretreatment |
| Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 1 - Baseline/Pretreatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 1 - Baseline/Pretreatment |
| Percentage of Subjects in Irritation Score Category for Gingiva at Day 1 - Baseline/Pretreatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 1 - Baseline/Pretreatment |
| Percentage of Subjects in Irritation Score Category for Tongue at Day 1 - Baseline/Pretreatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 1 - Baseline/Pretreatment |
| Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 1 - Baseline/Pretreatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 1 - Baseline/Pretreatment |
| Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 1 - Baseline/Pretreatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 1 - Baseline/Pretreatment |
| Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 1 - Post-treatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 1 - Post-treatment |
| Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 1 - Post-treatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 1 - Post-treatment |
| Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 1 - Post-treatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 1 - Post-treatment |
| Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 1 - Post-treatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 1 - Post-treatment |
| Percentage of Subjects in Irritation Score Category for Gingiva at Day 1 - Post-treatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 1 - Post-treatment |
| Percentage of Subjects in Irritation Score Category for Tongue at Day 1 - Post-treatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 1 - Post-treatment |
| Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 1 - Post-treatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 1 - Post-treatment |
| Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 1 - Post-treatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 1 - Post-treatment |
| Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 3 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 3 |
| Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 3 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 3 |
| Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 3 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 3 |
| Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 3 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 3 |
| Percentage of Subjects in Irritation Score Category for Gingiva at Day 3 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 3 |
| Percentage of Subjects in Irritation Score Category for Tongue at Day 3 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 3 |
| Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 3 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 3 |
| Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 3 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 3 |
| Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 5 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 5 |
| Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 5 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 5 |
| Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 5 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 5 |
| Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 5 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 5 |
| Percentage of Subjects in Irritation Score Category for Gingiva at Day 5 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 5 |
| Percentage of Subjects in Irritation Score Category for Tongue at Day 5 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 5 |
| Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 5 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 5 |
| Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 5 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 5 |
| Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 24 - Pretreatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 24 - Pretreatment |
| Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 24 - Pretreatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 24 - Pretreatment |
| Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 24 - Pretreatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 24 - Pretreatment |
| Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 24 - Pretreatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 24 - Pretreatment |
| Percentage of Subjects in Irritation Score Category for Gingiva at Day 24 - Pretreatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 24 - Pretreatment |
| Percentage of Subjects in Irritation Score Category for Tongue at Day 24 - Pretreatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 24 - Pretreatment |
| Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 24 - Pretreatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 24 - Pretreatment |
| Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 24 - Pretreatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 24 - Pretreatment |
| Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 24 - Post-treatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 24 - Post-treatment |
| Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 24 - Post-treatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 24 - Post-treatment |
| Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 24 - Post-treatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 24 - Post-treatment |
| Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 24 - Post-treatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 24 - Post-treatment |
| Percentage of Subjects in Irritation Score Category for Gingiva at Day 24 - Post-treatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 24 - Post-treatment |
| Percentage of Subjects in Irritation Score Category for Tongue at Day 24 - Post-treatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 24 - Post-treatment |
| Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 24 - Post-treatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 24 - Post-treatment |
| Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 24 - Post-treatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 24 - Post-treatment |
| Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 25 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 25 |
| Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 25 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 25 |
| Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 25 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 25 |
| Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 25 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 25 |
| Percentage of Subjects in Irritation Score Category for Gingiva at Day 25 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 25 |
| Percentage of Subjects in Irritation Score Category for Tongue at Day 25 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 25 |
| Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 25 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 25 |
| Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 25 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Day 25 |
| BG002 | 12027-020 | 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL) |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | 12027-020 | 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL) |
|
|
| Primary | Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Baseline/Pretreatment | Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal. | Analysis was based on subjects with measurements for this variable. | Posted | Number | Percentage of Participants | Day 1 - Baseline/Pretreatment |
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| Primary | Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 - Post-treatment | Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal. | Analysis was based on subjects with measurements for this variable. | Posted | Number | Percentage of Participants | Day 1 - Post-treatment |
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| Primary | Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 3 | Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal. | Analysis was based on subjects with measurements for this variable. | Posted | Number | Percentage of Participants | Day 3 |
|
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| Primary | Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 5 | Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal. | Analysis was based on subjects with measurements for this variable. | Posted | Number | Percentage of Participants | Day 5 |
|
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| Primary | Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 - Pretreatment | Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal. | Analysis was based on subjects with measurements for this variable. | Posted | Number | Percentage of Participants | Day 24 - Pretreatment |
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| Primary | Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 - Post-treatment | Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal. | Analysis was based on subjects with measurements for this variable. | Posted | Number | Percentage of Participants | Day 24 - Post-treatment |
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| Primary | Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 25 | Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal. | Analysis was based on subjects with measurements for this variable. | Posted | Number | Percentage of Participants | Day 25 |
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| Primary | Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Screening | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Screening |
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| Primary | Percentage of Subjects in Irritation Score Category for Labial Mucosa at Screening | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Screening |
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| Primary | Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Screening | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Screening |
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| Primary | Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Screening | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Screening |
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| Primary | Percentage of Subjects in Irritation Score Category for Gingiva at Screening | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Screening |
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| Primary | Percentage of Subjects in Irritation Score Category for Tongue at Screening | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Screening |
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| Primary | Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Screening | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Screening |
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| Primary | Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Screening | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Screening |
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| Primary | Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 1 - Baseline/Pretreatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 1 - Baseline/Pretreatment |
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| Primary | Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 1 - Baseline/Pretreatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 1 - Baseline/Pretreatment |
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| Primary | Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 1 - Baseline/Pretreatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 1 - Baseline/Pretreatment |
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| Primary | Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 1 - Baseline/Pretreatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 1 - Baseline/Pretreatment |
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| Primary | Percentage of Subjects in Irritation Score Category for Gingiva at Day 1 - Baseline/Pretreatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 1 - Baseline/Pretreatment |
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| Primary | Percentage of Subjects in Irritation Score Category for Tongue at Day 1 - Baseline/Pretreatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 1 - Baseline/Pretreatment |
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| Primary | Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 1 - Baseline/Pretreatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 1 - Baseline/Pretreatment |
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| Primary | Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 1 - Baseline/Pretreatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 1 - Baseline/Pretreatment |
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| Primary | Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 1 - Post-treatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 1 - Post-treatment |
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| Primary | Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 1 - Post-treatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 1 - Post-treatment |
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| Primary | Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 1 - Post-treatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 1 - Post-treatment |
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| Primary | Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 1 - Post-treatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 1 - Post-treatment |
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| Primary | Percentage of Subjects in Irritation Score Category for Gingiva at Day 1 - Post-treatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 1 - Post-treatment |
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| Primary | Percentage of Subjects in Irritation Score Category for Tongue at Day 1 - Post-treatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 1 - Post-treatment |
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| Primary | Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 1 - Post-treatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 1 - Post-treatment |
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| Primary | Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 1 - Post-treatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 1 - Post-treatment |
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| Primary | Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 3 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 3 |
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| Primary | Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 3 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 3 |
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| Primary | Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 3 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 3 |
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| Primary | Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 3 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 3 |
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| Primary | Percentage of Subjects in Irritation Score Category for Gingiva at Day 3 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 3 |
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| Primary | Percentage of Subjects in Irritation Score Category for Tongue at Day 3 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 3 |
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| Primary | Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 3 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 3 |
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|
|
| Primary | Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 3 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 3 |
|
|
|
| Primary | Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 5 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 5 |
|
|
|
| Primary | Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 5 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 5 |
|
|
|
| Primary | Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 5 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 5 |
|
|
|
| Primary | Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 5 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 5 |
|
|
|
| Primary | Percentage of Subjects in Irritation Score Category for Gingiva at Day 5 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 5 |
|
|
|
| Primary | Percentage of Subjects in Irritation Score Category for Tongue at Day 5 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 5 |
|
|
|
| Primary | Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 5 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 5 |
|
|
|
| Primary | Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 5 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 5 |
|
|
|
| Primary | Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 24 - Pretreatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 24 - Pretreatment |
|
|
|
| Primary | Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 24 - Pretreatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 24 - Pretreatment |
|
|
|
| Primary | Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 24 - Pretreatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 24 - Pretreatment |
|
|
|
| Primary | Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 24 - Pretreatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 24 - Pretreatment |
|
|
|
| Primary | Percentage of Subjects in Irritation Score Category for Gingiva at Day 24 - Pretreatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 24 - Pretreatment |
|
|
|
| Primary | Percentage of Subjects in Irritation Score Category for Tongue at Day 24 - Pretreatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 24 - Pretreatment |
|
|
|
| Primary | Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 24 - Pretreatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 24 - Pretreatment |
|
|
|
| Primary | Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 24 - Pretreatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 24 - Pretreatment |
|
|
|
| Primary | Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 24 - Post-treatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 24 - Post-treatment |
|
|
|
| Primary | Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 24 - Post-treatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 24 - Post-treatment |
|
|
|
| Primary | Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 24 - Post-treatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 24 - Post-treatment |
|
|
|
| Primary | Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 24 - Post-treatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 24 - Post-treatment |
|
|
|
| Primary | Percentage of Subjects in Irritation Score Category for Gingiva at Day 24 - Post-treatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 24 - Post-treatment |
|
|
|
| Primary | Percentage of Subjects in Irritation Score Category for Tongue at Day 24 - Post-treatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 24 - Post-treatment |
|
|
|
| Primary | Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 24 - Post-treatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 24 - Post-treatment |
|
|
|
| Primary | Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 24 - Post-treatment | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 24 - Post-treatment |
|
|
|
| Primary | Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 25 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 25 |
|
|
|
| Primary | Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 25 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 25 |
|
|
|
| Primary | Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 25 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 25 |
|
|
|
| Primary | Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 25 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 25 |
|
|
|
| Primary | Percentage of Subjects in Irritation Score Category for Gingiva at Day 25 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 25 |
|
|
|
| Primary | Percentage of Subjects in Irritation Score Category for Tongue at Day 25 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 25 |
|
|
|
| Primary | Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 25 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 25 |
|
|
|
| Primary | Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 25 | The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe). | Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data. | Posted | Number | Percentage of Participants | Day 25 |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | 12027-019 | 1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL) | 0 | 26 | 0 | 26 |
| EG002 | 12027-020 | 1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL) | 0 | 27 | 0 | 27 |
Principal investigator agreed not to publish the study results without prior sponsor approval.
| Title | Measurements |
|---|---|
|
| Sublingual Mucosa |
|
| Mucobuccal Fold |
|
| Gingiva |
|
| Tongue |
|
| Hard/Soft Palate |
|
| Uvula/Oropharynx |
|
| Teeth |
|
| Dental Restorations |
|
| Title | Measurements |
|---|---|
|
| Sublingual Mucosa |
|
| Mucobuccal Fold |
|
| Gingiva |
|
| Tongue |
|
| Hard/Soft Palate |
|
| Uvula/Oropharynx |
|
| Teeth |
|
| Dental Restorations |
|
| Title | Measurements |
|---|---|
|
| Sublingual Mucosa |
|
| Mucobuccal Fold |
|
| Gingiva |
|
| Tongue |
|
| Hard/Soft Palate |
|
| Uvula/Oropharynx |
|
| Teeth |
|
| Dental Restorations |
|
| Title | Measurements |
|---|---|
|
| Sublingual Mucosa |
|
| Mucobuccal Fold |
|
| Gingiva |
|
| Tongue |
|
| Hard/Soft Palate |
|
| Uvula/Oropharynx |
|
| Teeth |
|
| Dental Restorations |
|
| Title | Measurements |
|---|---|
|
| Sublingual Mucosa |
|
| Mucobuccal Fold |
|
| Gingiva |
|
| Tongue |
|
| Hard/Soft Palate |
|
| Uvula/Oropharynx |
|
| Teeth |
|
| Dental Restorations |
|
| Title | Measurements |
|---|---|
|
| Sublingual Mucosa |
|
| Mucobuccal Fold |
|
| Gingiva |
|
| Tongue |
|
| Hard/Soft Palate |
|
| Uvula/Oropharynx |
|
| Teeth |
|
| Dental Restorations |
|
| Title | Measurements |
|---|---|
|
| Sublingual Mucosa |
|
| Mucobuccal Fold |
|
| Gingiva |
|
| Tongue |
|
| Hard/Soft Palate |
|
| Uvula/Oropharynx |
|
| Teeth |
|
| Dental Restorations |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
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| Moderate |
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| Severe |
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| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
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| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
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| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
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| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
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| Title | Measurements |
|---|---|
|
| Moderate |
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| Severe |
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| Title | Measurements |
|---|---|
|
| Moderate |
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| Severe |
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| Title | Measurements |
|---|---|
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| Moderate |
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| Severe |
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| Title | Measurements |
|---|---|
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| Moderate |
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| Severe |
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| Title | Measurements |
|---|---|
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| Moderate |
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| Severe |
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| Title | Measurements |
|---|---|
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| Moderate |
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| Severe |
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| Title | Measurements |
|---|---|
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| Moderate |
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| Severe |
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| Title | Measurements |
|---|---|
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| Moderate |
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| Severe |
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| Title | Measurements |
|---|---|
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| Moderate |
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| Severe |
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| Title | Measurements |
|---|---|
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| Moderate |
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| Severe |
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| Title | Measurements |
|---|---|
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| Moderate |
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| Severe |
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| Title | Measurements |
|---|---|
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| Moderate |
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| Severe |
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| Title | Measurements |
|---|---|
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| Moderate |
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| Severe |
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| Title | Measurements |
|---|---|
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| Moderate |
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| Severe |
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| Title | Measurements |
|---|---|
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| Moderate |
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| Severe |
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| Title | Measurements |
|---|---|
|
| Moderate |
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| Severe |
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| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|