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This study is for people with sensitive teeth and involves going to the dentist for 6 visits over 8 weeks. During the first 2 weeks, everyone will just brush their teeth two times a day with the fluoride toothpaste provided.
Then you will be assigned to a mouthwash group if you qualify to continue in the study. Two groups will get mouthwash with a certain amount of an experimental ingredient and one group will get a mouthwash with no experimental ingredients. You will have an equal chance of being assigned to any one of the three groups.
For the next 6 weeks, you will rinse with your assigned mouthwash after brushing. 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 a double-blind, randomized, parallel group, single center, controlled clinical trial design. Approximately 200 generally healthy adults meeting the necessary inclusion/exclusion criteria will be enrolled so that 180 subjects (60 per treatment 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), Week 1, Week 2, Week 4 & Week 6. 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 standard fluoride toothpaste. Subjects will be instructed to rinse twice daily, after brushing, with the provided mouthrinse for 60 seconds using 10 ml or 20 ml (depending on the treatment group), for 6 consecutive weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PO-019 | Experimental | 1.40% Potassium Oxalate Sensitive Mouthwash without fluoride (12027-019) |
|
| PO-020 | Experimental | 1.40% Potassium Oxalate Sensitive Mouthwash with fluoride (12027-020) |
|
| PO-021 | Sham Comparator | Vehicle Control Mouthrinse (without potassium oxalate and without fluoride) (12027-021) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 12027-019 | Device | Rinse with 10 mL for 60 seconds twice daily after brushing in your usual manner for 1 minute using at least a one-inch strip of the assigned toothpaste. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Tactile Sensitivity Score at Week 6 | 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. | 6 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 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 |
| Mean Tactile Sensitivity Score at Week 1 | 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. | 1 Week |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Tactile Sensitivity VAS Score at Week 1 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angela Hee | 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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 12027-021 (Vehicle Control) | Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL) |
| FG001 | 12027-019 | 1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL) |
| FG002 | 12027-020 | 1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 12027-021 (Vehicle Control) | Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL) |
| BG001 | 12027-019 | 1.40% Potassium Oxalate Sensitive 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 | Mean Tactile Sensitivity Score at Week 6 | 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 Intent-to-Treat Analysis Set, which included 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 | 6 Weeks |
|
Day 43 ± 3 days, + 30 days for serious adverse events.
Adverse events were systematically collected at each study visit through Visit 6 (Day 43 ± 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 | 12027-021 (Vehicle Control) | Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 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 |
|---|---|
| D003807 | Dentin Sensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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|
| 12027-020 | Device | Rinse with 20 mL for 60 seconds twice daily after brushing in your usual manner for 1 minute using at least a one-inch strip of the assigned toothpaste. |
|
|
| 12027-021 | Device | Rinse with 10 mL for 60 seconds twice daily after brushing in your usual manner for 1 minute using at least a one-inch strip of the assigned toothpaste |
|
|
| 1 Week |
| 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 |
| Mean Tactile Sensitivity VAS Score at Week 6 | 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. | 6 Weeks |
| Mean Cold Air Stimulus VAS Score at Week 1 | 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. | 1 Week |
| 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 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. | 4 Weeks |
| Mean Cold Air Stimulus VAS Score at Week 6 | 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. | 6 Weeks |
| Global Subjective VAS Score at Week 1 | At Week 1, 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 week 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. | 1 Week |
| Global Subjective VAS Score at Week 2 | At Week 2, 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 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 Week 4, 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 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 |
| Global Subjective VAS Score at Week 6 | At Week 6, 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 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. | 6 Weeks |
| BG002 | 12027-020 | 1.40% Potassium Oxalate Sensitive 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 |
|
1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL) |
| OG002 | 12027-020 | 1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL) |
|
|
|
| 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, at each visit. | Analysis was based on the Intent-to-Treat Analysis Set, which included 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 | 4 Weeks |
|
|
|
|
| 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, at each visit. | Analysis was based on the Intent-to-Treat Analysis Set, which included 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 | 2 Weeks |
|
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|
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| Primary | Mean Tactile Sensitivity Score at Week 1 | 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 Intent-to-Treat Analysis Set, which included 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 | 1 Week |
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| Secondary | Mean Tactile Sensitivity VAS Score at Week 1 | 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 Intent-to-Treat Analysis Set, which included 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) | 1 Week |
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| 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 Intent-to-Treat Analysis Set, which included 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 |
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| 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 Intent-to-Treat Analysis Set, which included 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 |
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| Secondary | Mean Tactile Sensitivity VAS Score at Week 6 | 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 Intent-to-Treat Analysis Set, which included 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) | 6 Weeks |
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| Secondary | Mean Cold Air Stimulus VAS Score at Week 1 | 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 Intent-to-Treat Analysis Set, which included 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) | 1 Week |
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| 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 Intent-to-Treat Analysis Set, which included 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 |
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| 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 Intent-to-Treat Analysis Set, which included 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 |
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| Secondary | Mean Cold Air Stimulus VAS Score at Week 6 | 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 Intent-to-Treat Analysis Set, which included 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) | 6 Weeks |
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| Secondary | Global Subjective VAS Score at Week 1 | At Week 1, 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 week 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 Analysis Set, which included 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) | 1 Week |
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| Secondary | Global Subjective VAS Score at Week 2 | At Week 2, 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 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 Analysis Set, which included 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 |
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| Secondary | Global Subjective VAS Score at Week 4 | At Week 4, 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 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 Analysis Set, which included 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 |
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| Secondary | Global Subjective VAS Score at Week 6 | At Week 6, 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 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 Analysis Set, which included 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) | 6 Weeks |
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|
|
| 0 |
| 58 |
| 0 |
| 58 |
| EG001 | 12027-019 | 1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL) | 0 | 58 | 0 | 58 |
| EG002 | 12027-020 | 1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL) | 0 | 58 | 0 | 58 |
Principal investigator agreed not to publish the study results without prior sponsor approval.
| 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 (Yeaple probe) score. | 0.217 | Per statistical analysis plan, if experimental rinse (12027-020) was better than vehicle control at Week 4 (p<0.05), testing for 12027-020 versus vehicle control proceeded to Week 2. Family-wise error rate was controlled at 0.05. | Mean Difference (Final Values) | -4.92 | Standard Error of the Mean | 3.969 | 2-Sided | 95 | -12.8 | 2.92 | No | Superiority or Other |
| 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 (Yeaple probe) score. | 0.129 | Per statistical analysis plan, if experimental rinse (12027-020) was better than vehicle control at Week 2 (p<0.05), testing for 12027-020 versus vehicle control proceeded to Week 1. Family-wise error rate was controlled at 0.05. | Mean Difference (Final Values) | -3.99 | Standard Error of the Mean | 2.613 | 2-Sided | 95 | -9.15 | 1.17 | 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 (Yeaple probe) score. | 0.472 | The significance threshold was 0.05. Family-wise error rate was controlled at 0.05. | Mean Difference (Final Values) | -0.96 | Standard Error of the Mean | 1.336 | 2-Sided | 95 | -3.60 | 1.67 | 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. | 0.763 | The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment. | Mean Difference (Final Values) | -0.82 | Standard Error of the Mean | 2.723 | 2-Sided | 95 | -6.20 | 4.55 | 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. | 0.311 | The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment. | Mean Difference (Final Values) | -2.90 | Standard Error of the Mean | 2.854 | 2-Sided | 95 | -8.54 | 2.73 | 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. | 0.583 | The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment. | Mean Difference (Final Values) | 1.91 | Standard Error of the Mean | 3.477 | 2-Sided | 95 | -4.95 | 8.78 | 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. | 0.708 | The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment. | Mean Difference (Final Values) | 1.36 | Standard Error of the Mean | 3.610 | 2-Sided | 95 | -5.77 | 8.48 | 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 VAS score. | 0.149 | The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment. | Mean Difference (Final Values) | -3.88 | Standard Error of the Mean | 2.679 | 2-Sided | 95 | -9.17 | 1.41 | 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 VAS score. | 0.260 | The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment. | Mean Difference (Final Values) | -3.66 | Standard Error of the Mean | 3.235 | 2-Sided | 95 | -10.0 | 2.73 | 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 VAS score. | 0.721 | The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment. | Mean Difference (Final Values) | -1.29 | Standard Error of the Mean | 3.599 | 2-Sided | 95 | -8.39 | 5.82 | 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 VAS score. | 0.928 | The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment. | Mean Difference (Final Values) | -0.33 | Standard Error of the Mean | 3.688 | 2-Sided | 95 | -7.61 | 6.95 | 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 global subjective VAS score. | 0.914 | The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment. | Mean Difference (Final Values) | -0.26 | Standard Error of the Mean | 2.371 | 2-Sided | 95 | -4.94 | 4.42 | 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 global subjective VAS score. | 0.043 | The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment. | Mean Difference (Final Values) | -6.10 | Standard Error of the Mean | 2.997 | 2-Sided | 95 | -12.0 | -0.18 | 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 global subjective VAS score. | 0.250 | The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment. | Mean Difference (Final Values) | -4.07 | Standard Error of the Mean | 3.526 | 2-Sided | 95 | -11.0 | 2.89 | 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 global subjective VAS score. | 0.115 | The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment. | Mean Difference (Final Values) | -5.84 | Standard Error of the Mean | 3.687 | 2-Sided | 95 | -13.1 | 1.44 | No | Superiority or Other |