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 healthy adults with mild-to-moderate 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: Experimental Floss


Participation Criteria
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Eligibility Criteria
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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.

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: Control - no flossing<br>Subjects brushed thoroughly for one minute with Crest® Cavity Protection toothpaste and an Oral-B® Indicator soft, manual toothbrush once daily. | |
| Experimental: Experimental Floss<br>Subjects brushed thoroughly for one minute with Crest® Cavity Protection toothpaste and an Oral-B® Indicator soft, manual toothbrush once daily. Subjects flossed once daily with the experimental floss. | Device: Experimental Floss<br>* Experimental Glide® floss with cetylpyridinium chloride ( 13% dry weight CPC)<br>* Other names: CPC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 weeks |