A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing

Gingivitis Clinical Trial

Official title:

A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00964860
• Other study ID #: 2009061
• Status: Completed
• Phase: Phase 3
• First received: August 20, 2009
• Last updated: October 2, 2012
• Start date: August 2009
• Est. completion date: August 2009

Study information

• Verified date: October 2012
• Source: Procter and Gamble
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingivitis

Intervention

Device:
• Glide dental floss
Glide waxed dental floss

Locations

Country	Name	City	State
Guatemala	Radiologio Oral Y Maxilofacial	Guatemala City

Sponsors (1)

Lead Sponsor	Collaborator
Procter and Gamble

Country where clinical trial is conducted

Guatemala, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No