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

Completed · Not applicable

Conditions studied: Dentin Sensitivity

In brief

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.

Key facts

Study ID

NCT01727258

Run by

Johnson & Johnson Consumer and Personal Products Worldwide

People needed

153

Starts

2012-12-01

Expected to finish

2013-02-01

Last updated by the study team

2015-06-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• BioSci Research America, Inc. — Las Vegas, Nevada, United States

Full record on ClinicalTrials.gov

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