Overview

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

Status:
Completed
Trial end date:
2013-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Johnson & Johnson Consumer and Personal Products Worldwide
Treatments:
Fluorides
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