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 60 healthy adults with pre-existing 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 3

Primary location

Radiologio Oral Y Maxilofacial

Guatemala City, Zone 9, Guatemala

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Glide dental floss

Device

Glide waxed dental floss

Primary outcomes

Mean Interproximal Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group

Time frame: 30 days

Gingivitis was scored using the Lobene Modified Gingival Index (a visual examination for inflammation) on all scorable teeth. For each tooth, six gingival areas (distobuccal, buccal, mesiobuccal, mesiolingual, lingual, and distolingual) were scored on a 5-point, categorical scale (0 = absence of inflammation; 4 = severe inflammation) corresponding to Inflammation

Secondary outcomes

Whole Mouth Mean Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group

Time frame: 30 days

Whole-mouth average MGI scores were calculated separately for each subject and visit by averaging the MGI scores of all gradable sites. Interpoximal average MGI scores were also calculated for each subject and visit by averaging over only interpoximal sites (buccal-mesial, buccal-distal, lingual-mesian, and lingual-distal).

Within each treatment, changes from baseline were analyzed using paired t-test. Between treatments mean comparisons were conducted using analysis of covariance with baseline MGI score as a covariate. All statistical comparisons were two-sided with a 5% significance level.

The average MGI score for a subject can range from 0 (no gingivitis) to 4 (inflammation on all gradable sites).

Sponsors and collaborators

Lead sponsor

Procter and Gamble

Industry

Registry information

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Aug 25, 2009
Registry last updated: Oct 31, 2012

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