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This study is for people with sensitive teeth and involves going to the dentist for 4 visits over 6 weeks. At each visit the dentist will look at the mouth, teeth, tongue and gums of participants, and check for sensitive teeth.
During the first 2 weeks, participants will brush their teeth 2 times a day with the fluoride toothpaste provided.
Then, if they qualify to continue in the study, participants will be assigned to one of two treatment groups for the last 4 weeks. Both groups will use assigned toothpaste currently sold on the market. Both groups will each have an investigative mouth rinse to use as well. Participants will have an equal chance of being assigned to any one of the three groups.
For the next 4 weeks, participants will use their assigned products according to the directions provided. At Visit 1, participants will be supervised while they brush their teeth to ensure they understand the directions. They will also have supervised use of the products at Visit 2.
Results will be analyzed to assess whether the mouthwashes help to reduce tooth sensitivity during the study.
This study will consist of run-in and treatment phases. To qualify for the study, participants must meet the inclusion/exclusion criteria and return tactile sensitivity scores within protocol-specified parameters at both the screening and baseline visits.
Run-in will consist of a 2-week period during which participants will use a sodium fluoride dentifrice. At the start of the first phase, participants will attend a Screening Visit. They will participate in the informed consent process, complete a medical/dental history, and be evaluated for tactile sensitivity to Yeaple probe and response to a cold air stimulus.
Participants who qualify through screening will begin a run-in period that will last approximately two weeks. The run-in period will be followed by a Baseline visit. Participants who continue to qualify through Baseline will be randomly assigned to one of two treatment groups.
During the four-week treatment period, all participants will brush their teeth twice daily for at least one minute in their usual manner, with their assigned toothpaste. After brushing, participants will rinse with water, and then rinse with 10 mL of their assigned experimental mouth rinse for 60 seconds.
The study duration is approximately six weeks with each participant visiting the clinical site four times.
Adverse events will be observed and collected by querying each participant at each visit for new or continuing symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KOX | Experimental | After brushing for at least one-minute using at least one-inch strip of toothpaste, rinse with water and then rinse 60 seconds with 10mL of mouth rinse, twice daily. Fluoride Toothpaste / Crest® Cavity Protection Regular and Experimental Mouth Rinse 12027-033 |
|
| PLA | Placebo Comparator | After brushing for at least one-minute using at least one-inch strip of toothpaste, rinse with water and then rinse 60 seconds with 10mL of mouth rinse, twice daily. Fluoride Toothpaste/Crest® Cavity Protection Regular and Placebo Mouth Rinse |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Mouth Rinse 12027-033 | Device | After brushing for at least one-minute using at least one-inch strip of toothpaste, rinse with water and then rinse 60 seconds with 10mL of mouth rinse, twice daily. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Reduction From Baseline by at Least 30% in Mean Cold Air VAS Stimulus Score at Week 4 | Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant. A participant was considered an individual success if the participant's mean cold air stimulus VAS score at Week 4 was at least 30% lower than the participant's mean baseline cold air stimulus VAS score. | 4 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Cold Air Stimulus VAS Score at Week 4 | Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Lynch | Johnson & Johnson Consumer and Personal Products Worldwide | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salus Research, Inc. | Fort Wayne | Indiana | 46825 | United States | ||
| Silverstone |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Control | Placebo Mouth Rinse (10 mL) twice daily after brushing |
| FG001 | 12027-033 | Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Control | Placebo Mouth Rinse (10 mL) twice daily after brushing |
| BG001 | 12027-033 | Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing |
| 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 Subjects With Reduction From Baseline by at Least 30% in Mean Cold Air VAS Stimulus Score at Week 4 | Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant. A participant was considered an individual success if the participant's mean cold air stimulus VAS score at Week 4 was at least 30% lower than the participant's mean baseline cold air stimulus VAS score. | Analysis was based on Full Analysis Set, which included all randomized subjects. | Posted | Number | percentage of participants | 4 Weeks |
|
Day 28 ± 3 days, +30 days for serious adverse events.
Adverse events were systematically collected at each study visit through Visit 4 (Day 28 ± 3 days). 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 | Placebo Control | Placebo Mouth Rinse (10 mL) twice daily after brushing |
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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 |
|---|---|
| D003807 | Dentin Sensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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|
| Placebo Mouth Rinse | Other | After brushing for at least one-minute using at least one-inch strip of toothpaste, rinse with water and then rinse 60 seconds with 10mL of mouth rinse, twice daily. |
|
|
| 4 Weeks |
| Mean Tactile Sensitivity Score at Week 4 | Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit. | 4 Weeks |
| Mean Cold Air Stimulus VAS Score at Week 2 | Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant. | 2 Weeks |
| Mean Tactile Sensitivity Score at Week 2 | Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit. | 2 Weeks |
| Percentage of Subjects With Reduction From Baseline by at Least 30% in Mean Cold Air VAS Stimulus Score at Week 2 | Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant. A participant was considered an individual success if the participant's mean cold air stimulus VAS score at Week 2 was at least 30% lower than the participant's mean baseline cold air stimulus VAS score. | 2 Weeks |
| Mean Tactile Sensitivity VAS Score at Week 2 | Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant. | 2 Weeks |
| Mean Tactile Sensitivity VAS Score at Week 4 | Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant. | 4 Weeks |
| Global Subjective VAS Score at Week 2 | At each visit, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows:"Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that elicit your dentinal hypersensitivity pain/discomfort since you have been using the product." The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. | 2 Weeks |
| Global Subjective VAS Score at Week 4 | At each visit, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows:"Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that elicit your dentinal hypersensitivity pain/discomfort since you have been using the product." The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. | 4 Weeks |
| Las Vegas |
| Nevada |
| 89121 |
| United States |
| Lost to Follow-up |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 |
| Placebo Control |
Placebo Mouth Rinse (10 mL) twice daily after brushing |
| OG001 | 12027-033 | Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing |
|
|
|
| Secondary | Mean Cold Air Stimulus VAS Score at Week 4 | Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant. | Analysis was based on the Full Analysis Set, which included all randomized subjects. | Posted | Least Squares Mean | Standard Error | units on a scale (mm) | 4 Weeks |
|
|
|
|
| Secondary | Mean Tactile Sensitivity Score at Week 4 | Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit. | Analysis was based on the Full Analysis Set, which included all randomized subjects. | Posted | Least Squares Mean | Standard Error | grams | 4 Weeks |
|
|
|
|
| Secondary | Mean Cold Air Stimulus VAS Score at Week 2 | Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant. | Analysis was based on the Full Analysis Set, which included all randomized subjects. | Posted | Least Squares Mean | Standard Error | units on a scale (mm) | 2 Weeks |
|
|
|
|
| Secondary | Mean Tactile Sensitivity Score at Week 2 | Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit. | Analysis was based on the Full Analysis Set, which included all randomized subjects. | Posted | Least Squares Mean | Standard Error | grams | 2 Weeks |
|
|
|
|
| Secondary | Percentage of Subjects With Reduction From Baseline by at Least 30% in Mean Cold Air VAS Stimulus Score at Week 2 | Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant. A participant was considered an individual success if the participant's mean cold air stimulus VAS score at Week 2 was at least 30% lower than the participant's mean baseline cold air stimulus VAS score. | Analysis was based on the Full Analysis Set, which included all randomized subjects. | Posted | Number | percentage of participants | 2 Weeks |
|
|
|
|
| Secondary | Mean Tactile Sensitivity VAS Score at Week 2 | Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant. | Analysis was based on the Full Analysis Set, which included all randomized subjects. | Posted | Least Squares Mean | Standard Error | units on a scale (mm) | 2 Weeks |
|
|
|
|
| Secondary | Mean Tactile Sensitivity VAS Score at Week 4 | Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant. | Analysis was based on the Full Analysis Set, which included all randomized subjects. | Posted | Least Squares Mean | Standard Error | units on a scale (mm) | 4 Weeks |
|
|
|
|
| Secondary | Global Subjective VAS Score at Week 2 | At each visit, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows:"Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that elicit your dentinal hypersensitivity pain/discomfort since you have been using the product." The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. | Analysis was based on the Full Analysis Set, which included all randomized subjects. | Posted | Least Squares Mean | Standard Error | units on a scale (mm) | 2 Weeks |
|
|
|
|
| Secondary | Global Subjective VAS Score at Week 4 | At each visit, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows:"Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that elicit your dentinal hypersensitivity pain/discomfort since you have been using the product." The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. | Analysis was based on the Full Analysis Set, which included all randomized subjects. | Posted | Least Squares Mean | Standard Error | units on a scale (mm) | 4 Weeks |
|
|
|
|
| 0 |
| 186 |
| 0 |
| 186 |
| EG001 | 12027-033 | Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing | 0 | 189 | 0 | 189 |
Principal Investigators agreed not to publish the study results without prior sponsor approval.
| No |
| Superiority or Other |
For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.
| No |
| Superiority or Other |
For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.
| No |
| Superiority or Other |
For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.
| No |
| Superiority or Other |
| No |
| Superiority or Other |
| No |
| Superiority or Other |
| No |
| Superiority or Other |
| No |
| Superiority or Other |
| No |
| Superiority or Other |