A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Procter and Gamble
ClinicalTrials.gov Identifier:
NCT00964860
First received: August 20, 2009
Last updated: October 2, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Gingivitis
Device: Glide dental floss
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing

Further study details as provided by Procter and Gamble:

Primary Outcome Measures:
  • Mean Interproximal Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Whole Mouth Mean Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group [ Time Frame: 30 days ] [ Designated as safety issue: No ]

    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).



Enrollment: 60
Study Start Date: August 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Glide dental floss

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00964860

Locations
Guatemala
Radiologio Oral Y Maxilofacial
Guatemala City, Guatemala, Zone 9
Sponsors and Collaborators
Procter and Gamble
Investigators
Study Director: Jon Witt, PhD Procter and Gamble
  More Information

No publications provided

Responsible Party: Procter and Gamble
ClinicalTrials.gov Identifier: NCT00964860     History of Changes
Other Study ID Numbers: 2009061
Study First Received: August 20, 2009
Results First Received: June 28, 2012
Last Updated: October 2, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Gingivitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on April 23, 2014