CompletedNot Applicable

Study of an Experimental Toothbrush for Treatment and Prevention of Gingivitis

United States153 participantsStarted 2010-09-13

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * Currently taking steroids, antibiotic medication or any other medication within the previous month…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Whole-mouth Mean Modified Gingival Index (MGI) Score at Day 42

Timeframe: Day 42

Trial details

NCT IDNCT01224158

SponsorJohnson & Johnson Consumer and Personal Products Worldwide

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-10-29

Results submitted2019-11-15

View on ClinicalTrials.gov More Dental Devices, Home Care trials