A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing
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|ClinicalTrials.gov Identifier: NCT00964860|
Recruitment Status : Completed
First Posted : August 25, 2009
Results First Posted : October 31, 2012
Last Update Posted : October 31, 2012
|Condition or disease||Intervention/treatment||Phase|
|Gingivitis||Device: Glide dental floss||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- 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
- 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).
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
|Radiologio Oral Y Maxilofacial|
|Guatemala City, Guatemala, Zone 9|
|Study Director:||Jon Witt, PhD||Procter and Gamble|