Phase 4
N=60
A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing
Gingivitis
Bottom Line
View on ClinicalTrials.gov: NCT00855933 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcome: Primary: Whole Mouth Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group [30 Days] Units on the MGI Scale — 1.84; 1.73 units on a scale — p=0.126
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Experimental Floss (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Procter and Gamble
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Whole Mouth Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group [30 Days] Units on the MGI Scale |
1.84; 1.73 | 0.126 |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00855933). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.