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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier:
NCT01727258
First received: November 12, 2012
Last updated: June 8, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention
Dentin Sensitivity
Device: Mouth Rinse
Drug: Fluoride Toothpaste
Drug: Potassium Nitrate Toothpaste

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Official Title: Evaluation of an Experimental Mouth Rinse Device for Relieving Dentinal Hypersensitivity

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:
  • Mean Tactile Sensitivity Score at Week 4 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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 VAS Score at Week 2 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 153
Study Start Date: December 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Sensodyne® Original

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01727258

Locations
United States, Nevada
BioSci Research America, Inc.
Las Vegas, Nevada, United States, 89121
Sponsors and Collaborators
Johnson & Johnson Consumer and Personal Products Worldwide
Investigators
Study Director: Michael Lynch, DMD, PhD Johnson & Johnson Consumer and Personal Products Worldwide
  More Information

No publications provided

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT01727258     History of Changes
Other Study ID Numbers: KOXDHY0008
Study First Received: November 12, 2012
Results First Received: May 20, 2015
Last Updated: June 8, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:
Tooth Sensitivity

Additional relevant MeSH terms:
Dentin Sensitivity
Stomatognathic Diseases
Tooth Diseases
Fluorides
Cariostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on August 26, 2015