A Study of the Relief of Tooth Sensitivity of an Experimental Mouthrinse Device

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. 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.

Key facts

Study ID

NCT01345292

Run by

Johnson & Johnson Consumer and Personal Products Worldwide

People needed

226

Starts

2011-04-01

Expected to finish

2011-05-01

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…

• 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).

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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