Evaluate Dental Plaque Benefit of a Preventive Treatment Gel

• Status: Completed
• Trial end date: 2018-06-22
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Procter and Gamble
• Treatments: Fluorides; Sodium Fluoride

Criteria

Inclusion Criteria:

• 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.