A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing

Phase 4

Completed

• Conditions: Gingivitis

• Registration Number: NCT00855933
• Lead Sponsor: Procter and Gamble

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Study First Submitted: 2009-03-03
• Study First Submitted QC: 2009-03-04
• Study First Posted: 2009-03-05
• Results First Submitted: 2012-12-03
• Status Verified: 2013-01
• Results First Submitted QC: 2013-01-07
• Last Update Submitted: 2013-01-07
• Results First Posted: 2013-02-08
• Last Update Posted: 2013-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Whole Mouth Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group [30 Days] Units on the MGI Scale	4 weeks	A whole-mouth average Lobene Modified Gingival Index was calculated by summing the scores and dividing by the number of sites graded (excludes missing teeth \& sites not graded). Whole mouth average can range from 0 (normal) to 4 (severe inflammation).; For each tooth, six gingival areas (distobuccal, buccal, mesiobuccal, mesiolingual, lingual, and distolingual) were scored using the following scale: 0=Normal (Absence of inflammation, 1=Mild inflammation (slight change in color, little change in texture) of any portion of but not the entire marginal or papillary gingival unit, 2=Mild inflammation criteria as above but involving the entire marginal or papillary gingival unit, 3=Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the marginal or papillary gingival unit, 4=Severe inflammation (marked redness, edema and/or hypertrophy, spontaneous bleeding or ulceration) of the marginal or papillary gingival unit.

Trial Locations

Locations (2)

Dr. Geza Terézhalmy, DDS , MA; 🇺🇸 San Antonio, Texas, United States

Luis R. Archila, DDS; 🇬🇹 Guatemala City, Guatemala