A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing

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.

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Key information

Conditions

Gingivitis Gingival Diseases Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Luis R. Archila, DDS, Guatemala City, Guatemala

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Experimental Floss

Device

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

Other names: Glide®, floss, cetylpyridinium chloride, CPC

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Procter and Gamble

Industry

Registry information

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Mar 5, 2009
Registry last updated: Feb 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed