Clinical trial NCT01345292: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dentin Sensitivity
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2011-05-02
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Mean Tactile Sensitivity Score at Week 4
timeFrame: 4 weeks
measure: Mean Tactile Sensitivity Score at Week 2
timeFrame: 2 weeks
Secondary outcomes:
measure: Mean Tactile Sensitivity Visual Analog Scale (VAS) Score at Week 2
timeFrame: 2 weeks
measure: Mean Tactile Sensitivity VAS Score at Week 4
timeFrame: 4 weeks
measure: Mean Cold Air Stimulus VAS Score at Week 2
timeFrame: 2 weeks
measure: Mean Cold Air Stimulus VAS Score at Week 4
timeFrame: 4 weeks
measure: Global Subjective VAS Score at Week 2
timeFrame: 2 weeks
measure: Global Subjective VAS Score at Week 4
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: BioSci Research America, Inc.
state: Nevada
Study officials:
affiliation: Johnson & Johnson Consumer and Personal Products Worldwide
name: Michael Lynch, DMD, PhD
role: STUDY_DIRECTOR
References:
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.