A Test on a New Experimental Mouth Rinse for Relieving Tooth Sensitivity

June 8, 2015 updated by: Johnson & Johnson Consumer and Personal Products Worldwide

Evaluation of an Experimental Mouth Rinse Device for Relieving Dentinal Hypersensitivity

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

153

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Mouth Rinse
Twice daily for 28 days, brush in usual manner for at least one minute using at least a one-inch strip of Fluoride Toothpaste provided. Rinse with water after brushing teeth. Then rinse for 60 seconds with 10 mL of the experimental Mouth Rinse 12027-033 (KOX).
Device: Mouth Rinse
Mouth rinse 12027-033 used twice daily for 28 days after brushing.
Drug: Fluoride Toothpaste
Fluoride Toothpaste used daily for 28 days.
Other Names:
  • Colgate® Cavity Protection Regular
ACTIVE_COMPARATOR: Fluoride Toothpaste
Twice daily for 28 days, brush in usual manner for at least one minute using at least a one-inch strip of the Fluoride Toothpaste (NEG) provided.
Drug: Fluoride Toothpaste
Fluoride Toothpaste used daily for 28 days.
Other Names:
  • Colgate® Cavity Protection Regular
ACTIVE_COMPARATOR: Potassium Nitrate Toothpaste
Twice daily for 28 days, brush in usual manner for at least one minute using at least a one-inch strip of the Potassium Nitrate Toothpaste (POS) provided.
Drug: Potassium Nitrate Toothpaste
Potassium Nitrate Toothpaste used daily for 28 days.
Other Names:
  • Sensodyne® Original

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Tactile Sensitivity Score at Week 4
Time Frame: 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.
4 weeks
Mean Tactile Sensitivity Score at Week 2
Time Frame: 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.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Tactile Sensitivity VAS Score at Week 2
Time Frame: 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.
2 weeks
Mean Tactile Sensitivity VAS Score at Week 4
Time Frame: 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.
4 weeks
Mean Cold Air Stimulus VAS Score at Week 2
Time Frame: 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.
2 weeks
Mean Cold Air Stimulus VAS Score at Week 4
Time Frame: 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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Consumer and Personal Products Worldwide

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ACTUAL)

February 1, 2013

Study Completion (ACTUAL)

February 1, 2013

Study Registration Dates

First Submitted

November 12, 2012

First Submitted That Met QC Criteria

November 12, 2012

First Posted (ESTIMATE)

November 15, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

June 10, 2015

Last Update Submitted That Met QC Criteria

June 8, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KOXDHY0008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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