A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing

Procter & Gamble (P&G)

Status and phase: Completed; Phase 4

Conditions: Gingivitis

Treatments: Device: Experimental Floss

Study type: Interventional

Funder types: Industry

Identifiers

NCT00855933

2008110

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 healthy adults with mild-to-moderate gingivitis.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• at least 18 years of age;
• physically able to floss his/her teeth;
• refrained from performing oral hygiene the morning of the Baseline visit;
• have measurable gingivitis on at least 5 test sites;
• in good general health.

Exclusion criteria

• severe periodontal disease
• atypical discoloration or pigmentation in the gingival tissue;
• meaningful malocclusion of the anterior 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Control - no flossing

No Intervention group

Description:

Subjects brushed thoroughly for one minute with Crest® Cavity Protection toothpaste and an Oral-B® Indicator soft, manual toothbrush once daily.

Experimental Floss

Experimental group

Description:

Subjects brushed thoroughly for one minute with Crest® Cavity Protection toothpaste and an Oral-B® Indicator soft, manual toothbrush once daily. Subjects flossed once daily with the experimental floss.

Treatment:

Device: Experimental Floss