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

Assessment of a Potassium Oxalate-Containing Formulation for the Relief of Dentinal Hypersensitivity

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.

Study Overview

• Status: Completed
• Conditions: Dentin Sensitivity
• Intervention / Treatment: Device: Mouthwash; Drug: Potassium nitrate toothpaste; Drug: Sodium fluoride toothpaste

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.

• Study Type: Interventional
• Enrollment (Actual): 226
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89121
      • BioSci Research America, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 12027-027; 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	Device: Mouthwash; 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; Other Names: 1.40% potassium oxalate sensitive mouthwash
ACTIVE_COMPARATOR: 310158077046; Brush in your usual manner twice daily for at least one minute using at least a one-inch strip of the assigned toothpaste	Drug: Potassium nitrate toothpaste; Brush in your usual manner twice daily for at least one minute using at least a one-inch strip of the assigned toothpaste; Other Names: 5% Potassium nitrate toothpaste; Sensodyne Original
PLACEBO_COMPARATOR: 037000003212; Brush in your usual manner twice daily for at least one minute using at least a one-inch strip of the assigned toothpaste	Drug: Sodium fluoride toothpaste; Brush in your usual manner twice daily for at least one minute using at least a one-inch strip of the assigned toothpaste; Other Names: Crest Cavity Protection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (ACTUAL): May 1, 2011
• Study Completion (ACTUAL): May 1, 2011

Study Registration Dates

• First Submitted: April 28, 2011
• First Submitted That Met QC Criteria: April 28, 2011
• First Posted (ESTIMATE): May 2, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): June 10, 2015
• Last Update Submitted That Met QC Criteria: June 8, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Stomatognathic Diseases; Tooth Diseases; Hypersensitivity; Dentin Sensitivity; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Protective Agents; Cariostatic Agents; Listerine; Fluorides; Sodium Fluoride
• Other Study ID Numbers: KOXDHY0005