Evaluate Dental Plaque Benefit of a Preventive Treatment Gel

Procter & Gamble (P&G)

Status and phase

Completed

Phase 3

Conditions

Dental Plaque

Treatments

Drug: Marketed Control

Drug: Preventive Gel

Study type

Interventional

Funder types

Industry

Identifiers

2018009

Details and patient eligibility

About

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

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.