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A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00964860
Recruitment Status : Completed
First Posted : August 25, 2009
Results First Posted : October 31, 2012
Last Update Posted : October 31, 2012
Sponsor:
Information provided by (Responsible Party):
Procter and Gamble

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gingivitis Device: Glide dental floss Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing
Study Start Date : August 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Mean Interproximal Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group [ Time Frame: 30 days ]
    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 :
  1. Whole Mouth Mean Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group [ Time Frame: 30 days ]

    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).



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00964860


Locations
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Guatemala
Radiologio Oral Y Maxilofacial
Guatemala City, Guatemala, Zone 9
Sponsors and Collaborators
Procter and Gamble
Investigators
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Study Director: Jon Witt, PhD Procter and Gamble
More Information
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Responsible Party: Procter and Gamble
ClinicalTrials.gov Identifier: NCT00964860    
Other Study ID Numbers: 2009061
First Posted: August 25, 2009    Key Record Dates
Results First Posted: October 31, 2012
Last Update Posted: October 31, 2012
Last Verified: October 2012
Additional relevant MeSH terms:
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Gingivitis
Infections
Gingival Diseases
 Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases