Phase 3
N=60
A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing
Gingivitis
Bottom Line
View on ClinicalTrials.gov: NCT00964860 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcome: Primary: Mean Interproximal Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group — 2.11; 1.87 units on a scale — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Glide dental floss (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Procter and Gamble
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Interproximal Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group |
2.11; 1.87 | 0.001 sig |
| SECONDARY Whole Mouth Mean Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group |
2.06; 1.86 | 0.004 sig |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00964860). 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.