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The primary objective of this exploratory study is to evaluate the efficacy of an Oral Irrigator in the reduction of gingivitis compared to a negative control over a 3 week period by using the Modified Gingival Index and the Gingival Bleeding Index. The secondary objective is to evaluate the efficacy of an Oral Irrigator in the reduction of plaque compared to a negative control using the extended Turesky Modified Quigley-Hein Index (TQHPI) after 3 weeks of use.
This is a single-center, examiner-blind, three (3) week, two (2) treatment, parallel group, randomized study design. Thirty (30) subjects who have shown evidence of gingivitis and plaque will be enrolled in this study. Subjects will be evaluated for gingivitis using the Modified Gingival Index (MGI) and the Gingival Bleeding Index (GBI) and evaluated for plaque using the Turesky Modified Quigley-Hein Plaque Index (TQHPI) at two (2) time points: Baseline and after three (3) weeks of product use. Qualified subjects will be stratified and randomly assigned to one of the two treatment groups, toothbrushing on conjunction with an Oral Irrigator or toothbrushing without an Oral Irrigator (N=15/treatment). Subjects will be instructed to brush twice a day for approximately three (3) weeks with their assigned products and return for plaque and gingivitis measures at approximately three (3) weeks after the Baseline visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Regimen | Experimental | Oral Irrigator + Manual toothbrush + toothpaste Subjects will brush their teeth twice daily and will use the oral irrigator once in the evening daily |
|
| Control Regimen | Sham Comparator | Manual toothbrush + toothpaste Subjects will brush their teeth twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Water Flosser | Device | A pressurized stream of water to reduce gingivitis and remove adherent plaque |
|
| Measure | Description | Time Frame |
|---|---|---|
| MGI-Modified Gingival Index | Modified Gingival Index score after 3 weeks of product use. Gingivitis will be scored on the buccal and lingual marginal gingival and interdental papilla of all scorable teeth (six scores per tooth):0 = normal (absence of inflammation); 1 = mild inflammation (slight change of color, little change in texture) of any portion of the gingival unit; 2 = mild inflammation of the entire gingival unit; 3 = moderate inflammation (moderate glazing, redness, edema and/or hypertrophy) of the gingival unit; 4 = severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding or ulceration) of the gingival unit. MGI whole mouth score is computed by summing the scores and dividing by the number of scorable sites examined. | MGI Score after 3 weeks of product use. |
| GBI-Gingival Bleeding Index | Gingival Bleeding Index score after 3 weeks of product use. Each of the 3 gingival areas, i.e., buccal, mesial/dystal and lingual, of the teeth will be probed in this manner waiting approximately 30 seconds before recording the number of gingival units which bleed, according to the following scale: 0 = absence of bleeding after 30 seconds; 1 = bleeding observed after 30 seconds; 2 = immediate bleeding observed. GBI whole mouth score is computed by summing the scores and dividing by the number of scorable sites examined. | GBI score after 3 weeks of product use. |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque- TMQHP | Turesky Modified Quigley-Hein Plaque Index score after 3 weeks of product use. The plaque deposits on the buccal, lingual, and whole mouth average plaque scores will be calculated for each subject and tooth surfaces by totaling the scores and dividing by the number of gradable sites examined. Scoring criteria are shown below. 0=No Plaque; 1=Separate flecks of plaque at the cervical margin; 2=A thin, continuous band of plaque (up to 1 mm) at the cervical margin; 3=A band of plaque wider than 1mm, but covering less than one third of the side of the crown of the tooth; 4=Plaque covering at least one third, but less than two thirds of the side of the crown of the tooth; 5=Plaque covering two thirds or more of the side of the crown of the tooth; 8=Ungradable site; 9=Missing tooth |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salus Research | Fort Wayne | Indiana | 46825 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Regimen | Oral Irrigator + Manual toothbrush + toothpaste Subjects will brush their teeth twice daily and will use the oral irrigator once in the evening daily Water Flosser: A pressurized stream of water to reduce gingivitis and remove adherent plaque |
| FG001 | Control Regimen | Manual toothbrush + toothpaste Subjects will brush their teeth twice daily Control: No Oral Irrigator Control |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Regimen | Oral Irrigator + Manual toothbrush + toothpaste Subjects will brush their teeth twice daily and will use the oral irrigator once in the evening daily Water Flosser: A pressurized stream of water to reduce gingivitis and remove adherent plaque |
| BG001 | Control Regimen |
| 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 | MGI-Modified Gingival Index | Modified Gingival Index score after 3 weeks of product use. Gingivitis will be scored on the buccal and lingual marginal gingival and interdental papilla of all scorable teeth (six scores per tooth):0 = normal (absence of inflammation); 1 = mild inflammation (slight change of color, little change in texture) of any portion of the gingival unit; 2 = mild inflammation of the entire gingival unit; 3 = moderate inflammation (moderate glazing, redness, edema and/or hypertrophy) of the gingival unit; 4 = severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding or ulceration) of the gingival unit. MGI whole mouth score is computed by summing the scores and dividing by the number of scorable sites examined. | Posted | Least Squares Mean | Standard Error | score on a scale | MGI Score after 3 weeks of product use. |
|
after 3 weeks of product use
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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 | Test Regimen | Oral Irrigator + Manual toothbrush + toothpaste Subjects will brush their teeth twice daily and will use the oral irrigator once in the evening daily Water Flosser: A pressurized stream of water to reduce gingivitis and remove adherent plaque |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Manager | Procter & Gamble | 5136225362 | combs.cs@pg.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 20, 2021 | Mar 23, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| D058225 | Plaque, Amyloid |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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Subjects will proceed to an area separated from the examiner/examination area to receive supervised oral hygiene instructions and product usage instructions.
| Control | Other | No Oral Irrigator Control |
|
| TMQHP score after 3 weeks of product use. |
Manual toothbrush + toothpaste Subjects will brush their teeth twice daily Control: No Oral Irrigator Control |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Control Regimen | Manual toothbrush + toothpaste Subjects will brush their teeth twice daily Control: No Oral Irrigator Control |
|
|
| Primary | GBI-Gingival Bleeding Index | Gingival Bleeding Index score after 3 weeks of product use. Each of the 3 gingival areas, i.e., buccal, mesial/dystal and lingual, of the teeth will be probed in this manner waiting approximately 30 seconds before recording the number of gingival units which bleed, according to the following scale: 0 = absence of bleeding after 30 seconds; 1 = bleeding observed after 30 seconds; 2 = immediate bleeding observed. GBI whole mouth score is computed by summing the scores and dividing by the number of scorable sites examined. | Posted | Least Squares Mean | Standard Error | score on a scale | GBI score after 3 weeks of product use. |
|
|
|
| Secondary | Plaque- TMQHP | Turesky Modified Quigley-Hein Plaque Index score after 3 weeks of product use. The plaque deposits on the buccal, lingual, and whole mouth average plaque scores will be calculated for each subject and tooth surfaces by totaling the scores and dividing by the number of gradable sites examined. Scoring criteria are shown below. 0=No Plaque; 1=Separate flecks of plaque at the cervical margin; 2=A thin, continuous band of plaque (up to 1 mm) at the cervical margin; 3=A band of plaque wider than 1mm, but covering less than one third of the side of the crown of the tooth; 4=Plaque covering at least one third, but less than two thirds of the side of the crown of the tooth; 5=Plaque covering two thirds or more of the side of the crown of the tooth; 8=Ungradable site; 9=Missing tooth | Posted | Least Squares Mean | Standard Error | score on a scale | TMQHP score after 3 weeks of product use. |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Control Regimen | Manual toothbrush + toothpaste Subjects will brush their teeth twice daily Control: No Oral Irrigator Control | 0 | 15 | 0 | 15 | 0 | 15 |
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| D009057 |
| Stomatognathic Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |