Clinical trial NCT01727258: A Test on a New Experimental Mouth Rinse for Relieving Tooth Sensitivity
Official title: Evaluation of an Experimental Mouth Rinse Device for Relieving Dentinal Hypersensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentin Sensitivity
Keywords: Tooth Sensitivity
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2012-11-15
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility 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

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 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
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: