Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is for people with sensitive teeth and involves going to the dentist for 4 visits over 6 weeks.
During the first 2 weeks, you will just brush your teeth two times a day with the fluoride toothpaste provided.
Then you will be assigned to a group if you qualify to continue in the study. All groups will get a marketed toothpaste and one group will also get a mouthwash with an experimental ingredient. You will have an equal chance of being assigned to any one of the three groups.
For the next 4 weeks, you will brush with your assigned toothpaste and rinse with your assigned mouthwash if assigned to the mouthwash group. A dentist will look at your mouth, teeth, tongue and gums and check for sensitive teeth. The investigators will see if the mouthwash helps to reduce tooth sensitivity during the study.
This is an observer-blind, randomized, parallel-group, single-center, controlled clinical trial. Approximately 246 generally healthy adults meeting the necessary inclusion/exclusion criteria will be enrolled so that 210 subjects (70 per group) would reasonably be expected to complete the study. Subjects will have their oral soft/hard tissues assessed and will be evaluated for sensitivity levels at Screening (Visit 1), Baseline (Visit 2), Visit 3 at Week 2 and Visit 4 at Week 4. During the first two weeks 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 brush their teeth two times daily for one minute in their usual manner using the provided toothpaste (standard fluoride toothpaste or 5% potassium nitrate toothpaste). Subjects assigned to the mouthrinse group will be instructed to rinse twice daily, after brushing, with the provided mouthrinse for 60 seconds using 10 ml, for 4 consecutive weeks.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 12027-027 | Experimental | Rinse with 10 ml of the assigned mouthwash for 60 seconds after you brush in your usual manner twice daily for one minute using at least a one-inch strip of the assigned toothpaste |
|
| 310158077046 | Active Comparator | Brush in your usual manner twice daily for at least one minute using at least a one-inch strip of the assigned toothpaste |
|
| 037000003212 | Placebo Comparator | Brush in your usual manner twice daily for at least one minute using at least a one-inch strip of the assigned toothpaste |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mouthwash | Device | Rinse with 10 ml of the assigned mouthwash for 60 seconds after you brush in your usual manner twice daily for one minute using at least a one-inch strip of the assigned toothpaste |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 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. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Tactile Sensitivity Visual Analog Scale (VAS) Score at Week 2 | Tooth sensitivity was measured using a 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Any medical or dental history or condition, or use of any medication or drug, that per protocol or in the opinion of the investigator might compromise subject comfort or safety, or the analysis of study results.
Volunteers who have been using any of the following within protocol-defined timeframes:
Women who are pregnant, nursing or plan to become pregnant during the course of the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Lynch, DMD, PhD | Johnson & Johnson Consumer and Personal Products Worldwide | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioSci Research America, Inc. | Las Vegas | Nevada | 89121 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23929644 | Derived | Sharma D, McGuire JA, Gallob JT, Amini P. Randomised clinical efficacy trial of potassium oxalate mouthrinse in relieving dentinal sensitivity. J Dent. 2013 Jul;41 Suppl 4:S40-8. doi: 10.1016/S0300-5712(13)70005-8. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Negative Control (Crest Regular Toothpaste) | Crest® Cavity Protection Regular Toothpaste (Brushing Only) |
| FG001 | Positive Control (Sensodyne Toothpaste) | Sensodyne® Original Toothpaste (Brushing Only) |
| FG002 | 12027-027 (1.40% Potassium Oxalate Mouth Rinse) | Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Negative Control (Crest Regular Toothpaste) | Crest® Cavity Protection Regular Toothpaste (Brushing Only) |
| BG001 | Positive Control (Sensodyne Toothpaste) | Sensodyne® Original Toothpaste (Brushing Only) |
| 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 | 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. | Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment. | Posted | Least Squares Mean | Standard Error | grams of force | 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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Negative Control (Crest Regular Toothpaste) | Crest® Cavity Protection Regular Toothpaste (Brushing Only) |
Not provided
Not provided
Not provided
| 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 |
Not provided
| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C546060 | hydrated silica gel-based toothpaste |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Potassium nitrate toothpaste | Drug | Brush in your usual manner twice daily for at least one minute using at least a one-inch strip of the assigned toothpaste |
|
|
| Sodium fluoride toothpaste | Drug | Brush in your usual manner twice daily for at least one minute using at least a one-inch strip of the assigned toothpaste |
|
|
| 2 weeks |
| Mean Tactile Sensitivity VAS Score at Week 4 | Tooth sensitivity was measured using a 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 |
| 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 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 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 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. | 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 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 solicit your dentinal hypersensitivity pain/discomfort since you first started 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 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 solicit your dentinal hypersensitivity pain/discomfort since you first started 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 |
| BG002 | 12027-027 (1.40% Potassium Oxalate Mouth Rinse) | Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse) |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Sensodyne® Original Toothpaste (Brushing Only) |
| OG002 | 12027-027 (1.40% Potassium Oxalate Mouth Rinse) | Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse) |
|
|
|
| Primary | 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. | Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment. | Posted | Least Squares Mean | Standard Error | grams of force | 2 weeks |
|
|
|
|
| Secondary | Mean Tactile Sensitivity Visual Analog Scale (VAS) Score at Week 2 | Tooth sensitivity was measured using a 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 Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment. | 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 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 Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment. | Posted | Least Squares Mean | Standard Error | units on a scale (mm) | 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 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 Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment. | Posted | Least Squares Mean | Standard Error | units on a scale (mm) | 2 weeks |
|
|
|
|
| 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 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 Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment. | 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 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 solicit your dentinal hypersensitivity pain/discomfort since you first started 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 Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment. | 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 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 solicit your dentinal hypersensitivity pain/discomfort since you first started 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 Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment. | Posted | Least Squares Mean | Standard Error | units on a scale (mm) | 4 weeks |
|
|
|
|
| 0 |
| 75 |
| 0 |
| 75 |
| EG001 | Positive Control (Sensodyne Toothpaste) | Sensodyne® Original Toothpaste (Brushing Only) | 0 | 76 | 0 | 76 |
| EG002 | 12027-027 (1.40% Potassium Oxalate Mouth Rinse) | Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse) | 0 | 75 | 0 | 75 |
Principal investigator agreed not to publish the study results without prior sponsor approval.
| The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups. | ANCOVA | Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score. | 0.004 | The significance threshold level was 0.05 (two-sided). Family-wise error was controlled at 0.05. | Mean Difference (Final Values) | 2.41 | Standard Error of the Mean | 0.818 | 2-Sided | 95 | 0.80 | 4.02 | No | Superiority or Other |
| The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups. | ANCOVA | Terms included treatment and baseline mean tactile sensitivity VAS score. | 0.035 | The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment. | Mean Difference (Final Values) | -4.43 | Standard Error of the Mean | 2.093 | 2-Sided | 95 | -8.56 | -0.31 | No | Superiority or Other |
| The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups. | ANCOVA | Terms included treatment and baseline mean tactile sensitivity VAS score. | <0.001 | The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment. | Mean Difference (Final Values) | -10.2 | Standard Error of the Mean | 2.553 | 2-Sided | 95 | -15.2 | -5.13 | No | Superiority or Other |
| The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups. | ANCOVA | Terms included treatment and baseline mean cold air stimulus VAS score. | 0.136 | The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment. | Mean Difference (Final Values) | -3.42 | Standard Error of the Mean | 2.288 | 2-Sided | 95 | -7.93 | 1.09 | No | Superiority or Other |
| The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups. | ANCOVA | Terms included treatment and baseline mean cold air stimulus VAS score. | <0.001 | The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment. | Mean Difference (Final Values) | -10.2 | Standard Error of the Mean | 2.527 | 2-Sided | 95 | -15.2 | -5.25 | No | Superiority or Other |
| The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups. | ANCOVA | Terms included treatment and baseline mean global subjective VAS score. | 0.522 | The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment. | Mean Difference (Final Values) | -1.30 | Standard Error of the Mean | 2.023 | 2-Sided | 95 | -5.29 | 2.69 | No | Superiority or Other |
| The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups. | ANCOVA | Terms included treatment and baseline mean global subjective VAS score. | 0.010 | The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment. | Mean Difference (Final Values) | -6.13 | Standard Error of the Mean | 2.344 | 2-Sided | 95 | -10.8 | -1.51 | No | Superiority or Other |