Status:
COMPLETED
A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing
Lead Sponsor:
Procter and Gamble
Conditions:
Gingivitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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
- 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
- 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.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00964860
Start Date
August 1 2009
End Date
August 1 2009
Last Update
October 31 2012
Active Locations (1)
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1
Radiologio Oral Y Maxilofacial
Guatemala City, Guatemala, Zone 9