A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing

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.

Study Overview

• Status: Completed
• Conditions: Gingivitis
• Intervention / Treatment: Device: Glide dental floss

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Guatemala
  • Guatemala City, Guatemala, Zone 9
    • Radiologio Oral Y Maxilofacial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Brushing Only; Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice
Experimental: Brushing + Flossing; Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss	Device: Glide dental floss; Glide waxed dental floss

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Procter and Gamble
• Investigators: Study Director: Jon Witt, PhD, Procter and Gamble

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: August 20, 2009
• First Submitted That Met QC Criteria: August 21, 2009
• First Posted (Estimate): August 25, 2009

Study Record Updates

• Last Update Posted (Estimate): October 31, 2012
• Last Update Submitted That Met QC Criteria: October 2, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis
• Other Study ID Numbers: 2009061