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

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ClinicalTrials.gov Identifier: NCT01727258
Recruitment Status : Completed
First Posted : November 15, 2012
Results First Posted : June 10, 2015
Last Update Posted : June 10, 2015
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide

Tracking Information
First Submitted Date  ICMJE November 12, 2012
First Posted Date  ICMJE November 15, 2012
Results First Submitted Date  ICMJE May 20, 2015
Results First Posted Date  ICMJE June 10, 2015
Last Update Posted Date June 10, 2015
Study Start Date  ICMJE December 2012
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2015)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT01727258 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2015)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Test on a New Experimental Mouth Rinse for Relieving Tooth Sensitivity
Official Title  ICMJE Evaluation of an Experimental Mouth Rinse Device for Relieving Dentinal Hypersensitivity
Brief Summary

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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Condition  ICMJE Dentin Sensitivity
Intervention  ICMJE
  • 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
  • Drug: Potassium Nitrate Toothpaste
    Potassium Nitrate Toothpaste used daily for 28 days.
    Other Name: Sensodyne® Original
Study Arms  ICMJE
  • 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).
    Interventions:
    • Device: Mouth Rinse
    • Drug: Fluoride Toothpaste
  • 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.
    Intervention: Drug: Fluoride Toothpaste
  • 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.
    Intervention: Drug: Potassium Nitrate Toothpaste
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 8, 2015)
153
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01727258
Other Study ID Numbers  ICMJE KOXDHY0008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johnson & Johnson Consumer and Personal Products Worldwide
Study Sponsor  ICMJE Johnson & Johnson Consumer and Personal Products Worldwide
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Michael Lynch, DMD, PhD Johnson & Johnson Consumer and Personal Products Worldwide
PRS Account Johnson & Johnson Consumer and Personal Products Worldwide
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP