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

August 20, 2009
October 2, 2012
August 2009
August 2009   (final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT00964860 on ClinicalTrials.gov Archive Site
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).

Not Provided
Not Provided
Not Provided
 
A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Gingivitis
Device: Glide dental floss
Glide waxed dental floss
Other Name: Glide dental floss
  • 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
    Intervention: Device: Glide dental floss
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
August 2009
August 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Guatemala
 
NCT00964860
2009061
No
Procter and Gamble
Procter and Gamble
Not Provided
Study Director: Jon Witt, PhD Procter and Gamble
Procter and Gamble
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP