Dentin Sensitivity
Conditions
Keywords
Tooth Sensitivity
Brief summary
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 subjects, and check for sensitive teeth. During the first 2 weeks, participants will brush their teeth two times a day with the fluoride toothpaste provided. Then, if they qualify to continue in the study, participants will be assigned to a treatment group. All the groups will get toothpaste currently sold on the market, and one group will get a mouthwash with an experimental ingredient to use as well. Subjects will have an equal chance of being assigned to any one of the three groups. For the next 4 weeks, subjects will use their assigned products according to the directions provided. At Visit 1 subjects will be supervised while they brush their teeth to ensure they understand the directions. They will also have supervised use of the product at Visit 2. We will see if the mouthwash helps to reduce tooth sensitivity during the study.
Detailed description
This study will consist of run-in and treatment phases. To qualify for the study, subjects 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 subjects will use a sodium fluoride dentifrice. At the start of the first phase, subjects 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. Subjects 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. Subjects who continue to qualify through Baseline will be randomized to one of three treatment groups. During the four-week treatment period, all subjects will brush their teeth twice daily for at least one minute in their usual manner, with their assigned toothpaste. After brushing, subjects assigned to the mouth rinse group will rinse with water, and then rinse with 10 mL of the experimental mouth rinse for 60 seconds. The study duration is approximately six weeks with each subject visiting the clinical site six times. Adverse events will be observed and collected by querying each subject at each visit for new or continuing symptoms.
Interventions
DEVICEMouth Rinse
Mouth rinse 12027-033 used twice daily for 28 days after brushing.
DRUGFluoride Toothpaste
Fluoride Toothpaste used daily for 28 days.
Potassium Nitrate Toothpaste used daily for 28 days.
Sponsors
Johnson & Johnson Consumer and Personal Products Worldwide
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Good general and oral health without any known allergy to commercial dental products or cosmetics * Evidence of a personally signed and dated informed consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial * Willingness to use the assigned products according to instructions, availability for appointments, and likelihood of completing the clinical trial * Dental condition appropriate for inclusion in the trial according to protocol-specified parameters and the professional opinion of the investigator * Adequate oral hygiene (i.e. brush teeth daily and exhibit no signs of oral neglect
Exclusion criteria
* Medical condition or history, or use of drugs or treatments that could possibly compromise the safety of the research subject or the interpretation of results, per protocol or in the opinion of the investigator * Use of home-care bleaching, whitening products or professional bleaching treatment within a protocol-specified time period * Use of desensitizing agents within a protocol-specified time period * Participation in a dental clinical trial involving oral care products within a protocol-specified time period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Tactile Sensitivity Score at Week 4 | 4 weeks | 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. |
| Mean Tactile Sensitivity Score at Week 2 | 2 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Tactile Sensitivity VAS Score at Week 2 | 2 weeks | 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. |
| Mean Tactile Sensitivity VAS Score at Week 4 | 4 weeks | 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. |
| Mean Cold Air Stimulus VAS Score at Week 2 | 2 weeks | 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. |
| Mean Cold Air Stimulus VAS Score at Week 4 | 4 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Colgate Regular Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007). | 51 |
| Sensodyne Toothpaste 5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046). | 51 |
| Potassium Oxalate Mouthrinse Potassium Oxalate Mouthrinse (experimental group)(12027-033). | 51 |
| Total | 153 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
| Overall Study | Noncompliance with Study Drug | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Colgate Regular | Sensodyne Toothpaste | Potassium Oxalate Mouthrinse | Total |
|---|---|---|---|---|
| Age, Continuous | 38.4 years STANDARD_DEVIATION 10.97 | 37.0 years STANDARD_DEVIATION 11.56 | 39.9 years STANDARD_DEVIATION 10.46 | 38.4 years STANDARD_DEVIATION 11 |
| Region of Enrollment USA | 51 participants | 51 participants | 51 participants | 153 participants |
| Sex: Female, Male Female | 33 Participants | 37 Participants | 39 Participants | 109 Participants |
| Sex: Female, Male Male | 18 Participants | 14 Participants | 12 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 51 | 0 / 51 | 0 / 51 |
| serious Total, serious adverse events | 0 / 51 | 0 / 51 | 0 / 51 |
Outcome results
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.
Time frame: 2 weeks
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Colgate Regular | Mean Tactile Sensitivity Score at Week 2 | 11.09 grams of force | Standard Error 0.832 |
| Sensodyne Toothpaste | Mean Tactile Sensitivity Score at Week 2 | 17.00 grams of force | Standard Error 0.84 |
| Potassium Oxalate Mouthrinse | Mean Tactile Sensitivity Score at Week 2 | 17.18 grams of force | Standard Error 0.832 |
Comparison: The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.p-value: <0.00195% CI: [3.76, 8.41]ANCOVA
Comparison: The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.p-value: 0.88195% CI: [-2.16, 2.52]ANCOVA
Comparison: The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.p-value: <0.00195% CI: [3.57, 8.24]ANCOVA
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.
Time frame: 4 weeks
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Colgate Regular | Mean Tactile Sensitivity Score at Week 4 | 11.21 grams of force | Standard Error 1.221 |
| Sensodyne Toothpaste | Mean Tactile Sensitivity Score at Week 4 | 23.81 grams of force | Standard Error 1.234 |
| Potassium Oxalate Mouthrinse | Mean Tactile Sensitivity Score at Week 4 | 22.07 grams of force | Standard Error 1.21 |
Comparison: The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.p-value: <0.00195% CI: [7.45, 14.25]ANCOVA
Comparison: The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.p-value: 0.31495% CI: [-5.16, 1.67]ANCOVA
Comparison: The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.p-value: <0.00195% CI: [9.17, 16.03]ANCOVA
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.
Time frame: 2 weeks
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Colgate Regular | Mean Cold Air Stimulus VAS Score at Week 2 | 45.41 units on a scale (mm) | Standard Error 2.233 |
| Sensodyne Toothpaste | Mean Cold Air Stimulus VAS Score at Week 2 | 32.89 units on a scale (mm) | Standard Error 2.246 |
| Potassium Oxalate Mouthrinse | Mean Cold Air Stimulus VAS Score at Week 2 | 37.15 units on a scale (mm) | Standard Error 2.227 |
Comparison: The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.p-value: 0.0195% CI: [-14.51, -2]ANCOVA
Comparison: The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.p-value: 0.17995% CI: [-1.98, 10.51]ANCOVA
Comparison: The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.p-value: <0.00195% CI: [-18.79, -6.25]ANCOVA
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.
Time frame: 4 weeks
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Colgate Regular | Mean Cold Air Stimulus VAS Score at Week 4 | 42.03 units on a scale (mm) | Standard Error 2.511 |
| Sensodyne Toothpaste | Mean Cold Air Stimulus VAS Score at Week 4 | 24.56 units on a scale (mm) | Standard Error 2.524 |
| Potassium Oxalate Mouthrinse | Mean Cold Air Stimulus VAS Score at Week 4 | 30.10 units on a scale (mm) | Standard Error 2.479 |
Comparison: The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.p-value: <0.00195% CI: [-18.93, -4.93]ANCOVA
Comparison: The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.p-value: 0.11995% CI: [-1.44, 12.53]ANCOVA
Comparison: The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.p-value: <0.00195% CI: [-24.52, -10.42]ANCOVA
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.
Time frame: 2 weeks
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Colgate Regular | Mean Tactile Sensitivity VAS Score at Week 2 | 43.80 units on a scale (mm) | Standard Error 2.009 |
| Sensodyne Toothpaste | Mean Tactile Sensitivity VAS Score at Week 2 | 36.95 units on a scale (mm) | Standard Error 2.02 |
| Potassium Oxalate Mouthrinse | Mean Tactile Sensitivity VAS Score at Week 2 | 37.08 units on a scale (mm) | Standard Error 2.017 |
Comparison: The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.p-value: 0.0295% CI: [-12.38, -1.05]ANCOVA
Comparison: The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.p-value: 0.96495% CI: [-5.52, 5.78]ANCOVA
Comparison: The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.p-value: 0.01795% CI: [-12.47, -1.23]ANCOVA
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.
Time frame: 4 weeks
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Colgate Regular | Mean Tactile Sensitivity VAS Score at Week 4 | 38.38 units on a scale (mm) | Standard Error 2.342 |
| Sensodyne Toothpaste | Mean Tactile Sensitivity VAS Score at Week 4 | 26.40 units on a scale (mm) | Standard Error 2.353 |
| Potassium Oxalate Mouthrinse | Mean Tactile Sensitivity VAS Score at Week 4 | 31.45 units on a scale (mm) | Standard Error 2.327 |
Comparison: The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.p-value: 0.03995% CI: [-13.5, -0.35]ANCOVA
Comparison: The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.p-value: 0.1395% CI: [-1.5, 11.61]ANCOVA
Comparison: The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.p-value: <0.00195% CI: [-18.53, -5.43]ANCOVA