A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing

Procter and Gamble60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Gingivitis

Interventions

Experimental FlossDEVICE

Experimental Glide® floss with cetylpyridinium chloride (\~13% dry weight CPC)

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Dr. Geza Terézhalmy, DDS , MA

San Antonio, Texas, United States

Luis R. Archila, DDS

Guatemala City, Guatemala

Outcomes

Primary Outcomes

Whole Mouth Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group [30 Days] Units on the MGI Scale

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.

Time frame: 4 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.