A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing

Study Overview
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Brief Summary
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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.

Official Title
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A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing

Conditions
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Gingivitis

Intervention / Treatment
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* Device: Glide dental floss


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Brushing Only<br>Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice | |
| Experimental: Brushing + Flossing<br>Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss | Device: Glide dental floss<br>* Glide waxed dental floss<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Interproximal Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group | 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 | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whole Mouth Mean Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group | 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). | 30 days |