A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing

Procter & Gamble (P&G)

Status and phase

Completed

Phase 3

Conditions

Gingivitis

Treatments

Device: Glide dental floss

Study type

Interventional

Funder types

Industry

Identifiers

NCT00964860

2009061

Details and patient eligibility

About

This is a randomized, controlled, examiner-blind, parallel group, four week clinical study comparing brushing plus flossing to brushing alone in 60 healthy adults with pre-existing gingivitis.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

In order to be included in the study, each subject must:

be at least 18 years of age;
be physically able to floss their teeth;
have a minimum of 18 natural teeth (teeth that are grossly carious, fully crowned, or extensively restored will not be included);
have refrained from performing oral hygiene the morning of the Baseline visit;
be in good general health;
have interproximal MGI (Modified Gingival Index) score of >2.8.

Exclusion criteria

Subjects are excluded from study participation where there is evidence of:

severe periodontal disease;
discoloration or pigmentation in the gingival tissue;
meaningful misalignment of front teeth;
fixed facial orthodontic appliances;
use of antibiotics within two weeks of the Baseline Visit and at any time during the study;
any diseases or conditions that could be expected to interfere with the subject safely completing the study.