Study of an Experimental Toothbrush for Treatment and Prevention of Gingivitis

Completed · Not applicable · Has a placebo group

Conditions studied: Dental Devices, Home Care

In brief

This study is 6 weeks long with 6 visits to a clinical site. People participating in this study will be asked to brush their teeth two times a day with a provided toothbrush. For one of those six weeks people will be asked to rinse with a mouthwash. During that time, people will use the mouthwash two times a day and will not be allowed to brush their teeth at all. The mouth, teeth, tongue and gums will be looked at by a dentist. At each visit, people will rinse with a pink liquid that will dye their mouths pink. The dye is temporary and will go away by the end of the day. They may also be asked to complete a short questionnaire about their experience.

Key facts

Study ID

NCT01224158

Run by

Johnson & Johnson Consumer and Personal Products Worldwide

People needed

153

Starts

2010-09-13

Expected to finish

2010-10-29

Last updated by the study team

2019-12-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Males and females at least 18 years of age and in good general and oral health.
• 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.
• Good general and oral health with manual dexterity.
• Willingness to refrain from all oral hygiene procedures within 18-24 hours prior to the study visit.
• A minimum of twenty scorable teeth with at least one scorable molar in each quadrant.
• A whole-mouth mean plaque level greater than 0.60 at Day 0.
• Whole-mouth-mean gingivitis level greater than or equal to 1.75 at Day 0.
• Absence of orthodontic bands, appliances, bridges, numerous crowns, extensive large restorations, excessive caries, removable orthodontic appliances or partial dentures.
• Absence of significant oral soft tissue pathology, excluding gingivitis, based on the visual oral examination and at the discretion of the examiner.
• Adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect).
• Absence of moderate/advanced periodontitis.
• Absence of extensive supragingival calculus.
• Absence of ulcerations on lips and oral mucosa.

You may not qualify if…

• Currently taking steroids, antibiotic medication or any other medication within the previous month that may interfere with the efficacy evaluations.
• Those requiring antibiotic premedication prior to dental treatment.
• Participation in a dental clinical trial involving oral care products currently or within the past 28 days.
• Dental prophylaxis within one week prior to enrollment into the study.
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
• Physical limitations or restrictions that might preclude use of normal oral hygiene procedures (i.e., toothbrushing, etc.).
• Self-reported pregnant or lactating women.

Where it is running

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

Full record on ClinicalTrials.gov

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