Evaluate Dental Plaque Benefit of a Preventive Treatment Gel

Completed · Phase 3

Conditions studied: Dental Plaque

In brief

The objective of the study is to evaluate anti-plaque efficacy of a preventive treatment gel in a modified 4-day plaque model.

Key facts

Study ID

NCT03546491

Run by

Procter and Gamble

People needed

32

Starts

2018-05-08

Expected to finish

2018-06-22

Last updated by the study team

2019-09-04

Who can join

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

You may qualify if…

• Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
• Be 18 years of age or older;
• Agree not to participate in any other oral/dental product studies during the study;
• Agree to delay any elective dentistry (including dental prophylaxis) until the study has been completed;
• Agree to refrain from the use of any non-study oral hygiene products (subjects who are regular flossers will be allowed to floss during acclimation and wash-out periods);
• Agree to use an oral hygiene product that contains stannous fluoride;
• Agree to refrain from any form of non-specified oral hygiene during the treatment period, including the use of products such as floss, toothpicks for plaque removal, and chewing gum;
• Agree to refrain from any oral hygiene, eating and drinking after 11:00 PM the evening before plaque measurements on Day 0 and Day 4 of the treatment periods;
• Agree to return for all scheduled visits and follow study procedures;
• Possess a minimum of 20 natural teeth with scorable facial and lingual surfaces, of which at least 4 are molars; and,
• Be in good general health, as determined by the Investigator/designee based on a review of the health history/update for participation in the study.
• Exclusion Criteria:• Have a medical condition requiring pre-medication prior to dental procedures;
• Have taken antibiotics within 2 weeks of the acclimation period or anticipate taking antibiotics at any time during the study;
• Have a history of allergies or hypersensitivity to dyes or dentifrices that contain stannous fluoride;
• Have removable or orthodontic appliances which interfere with obtaining 20 gradable teeth;
• Have previously demonstrated an inability to comply with study visit requirements;
• Have rampant caries, open or untreated caries, severe gingivitis or advanced periodontitis requiring prompt treatment; or,
• Present with any disease or condition(s) that could be expected to interfere with examination procedures or the subject's safe completion of the study.

Where it is running

• Oral Health Science Center — Mason, Ohio, United States

Full record on ClinicalTrials.gov

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