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A Study of the Relief of Tooth Sensitivity of an Experimental Mouthrinse Device

Primary Purpose

Dentin Sensitivity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mouthwash
Potassium nitrate toothpaste
Sodium fluoride toothpaste
Sponsored by
Johnson & Johnson Consumer and Personal Products Worldwide
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Dentin Sensitivity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males and females at least 18 years of age in 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.
  • The appropriate number and location of eligible teeth, based on protocol-defined standards.
  • Adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect).

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:

    • home-care bleaching, whitening products or professional bleaching treatment
    • desensitizing agents whether prescribed or over-the-counter
    • sensitivity toothpastes, mouthwash or oral care products used for the treatment of dentinal hypersensitivity
  • Women who are pregnant, nursing or plan to become pregnant during the course of the study.

Sites / Locations

  • BioSci Research America, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

12027-027

310158077046

037000003212

Arm Description

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

Brush in your usual manner twice daily for at least one minute using at least a one-inch strip of the assigned toothpaste

Brush in your usual manner twice daily for at least one minute using at least a one-inch strip of the assigned toothpaste

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
April 28, 2011
Last Updated
June 8, 2015
Sponsor
Johnson & Johnson Consumer and Personal Products Worldwide
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1. Study Identification

Unique Protocol Identification Number
NCT01345292
Brief Title
A Study of the Relief of Tooth Sensitivity of an Experimental Mouthrinse Device
Official Title
Assessment of a Potassium Oxalate-Containing Formulation for the Relief of Dentinal Hypersensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Consumer and Personal Products Worldwide

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Sensitivity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
226 (Actual)

8. Arms, Groups, and Interventions

Arm Title
12027-027
Arm Type
Experimental
Arm Description
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
Arm Title
310158077046
Arm Type
Active Comparator
Arm Description
Brush in your usual manner twice daily for at least one minute using at least a one-inch strip of the assigned toothpaste
Arm Title
037000003212
Arm Type
Placebo Comparator
Arm Description
Brush in your usual manner twice daily for at least one minute using at least a one-inch strip of the assigned toothpaste
Intervention Type
Device
Intervention Name(s)
Mouthwash
Other Intervention Name(s)
1.40% potassium oxalate sensitive mouthwash
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Potassium nitrate toothpaste
Other Intervention Name(s)
5% Potassium nitrate toothpaste, Sensodyne Original
Intervention Description
Brush in your usual manner twice daily for at least one minute using at least a one-inch strip of the assigned toothpaste
Intervention Type
Drug
Intervention Name(s)
Sodium fluoride toothpaste
Other Intervention Name(s)
Crest Cavity Protection
Intervention Description
Brush in your usual manner twice daily for at least one minute using at least a one-inch strip of the assigned toothpaste
Primary Outcome Measure Information:
Title
Mean Tactile Sensitivity Score at Week 4
Description
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
Title
Mean Tactile Sensitivity Score at Week 2
Description
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
Secondary Outcome Measure Information:
Title
Mean Tactile Sensitivity Visual Analog Scale (VAS) Score at Week 2
Description
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.
Time Frame
2 weeks
Title
Mean Tactile Sensitivity VAS Score at Week 4
Description
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.
Time Frame
4 weeks
Title
Mean Cold Air Stimulus VAS Score at Week 2
Description
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.
Time Frame
2 weeks
Title
Mean Cold Air Stimulus VAS Score at Week 4
Description
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.
Time Frame
4 weeks
Title
Global Subjective VAS Score at Week 2
Description
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.
Time Frame
2 weeks
Title
Global Subjective VAS Score at Week 4
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females at least 18 years of age in 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. The appropriate number and location of eligible teeth, based on protocol-defined standards. Adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect). 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: home-care bleaching, whitening products or professional bleaching treatment desensitizing agents whether prescribed or over-the-counter sensitivity toothpastes, mouthwash or oral care products used for the treatment of dentinal hypersensitivity Women who are pregnant, nursing or plan to become pregnant during the course of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Lynch, DMD, PhD
Organizational Affiliation
Johnson & Johnson Consumer and Personal Products Worldwide
Official's Role
Study Director
Facility Information:
Facility Name
BioSci Research America, Inc.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89121
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23929644
Citation
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.
Results Reference
derived

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A Study of the Relief of Tooth Sensitivity of an Experimental Mouthrinse Device

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