A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing
|ClinicalTrials.gov Identifier: NCT00855933|
Recruitment Status : Completed
First Posted : March 5, 2009
Results First Posted : February 8, 2013
Last Update Posted : February 8, 2013
|Condition or disease||Intervention/treatment||Phase|
|Gingivitis||Device: Experimental Floss||Phase 4|
|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 :||January 2009|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||February 2009|
No Intervention: Control - no flossing
Subjects brushed thoroughly for one minute with Crest® Cavity Protection toothpaste and an Oral-B® Indicator soft, manual toothbrush once daily.
Experimental: Experimental Floss
Subjects brushed thoroughly for one minute with Crest® Cavity Protection toothpaste and an Oral-B® Indicator soft, manual toothbrush once daily. Subjects flossed once daily with the experimental floss.
Device: Experimental Floss
Experimental Glide® floss with cetylpyridinium chloride (~13% dry weight CPC)
- Whole Mouth Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group [30 Days] Units on the MGI Scale [ Time Frame: 4 weeks ]
A whole-mouth average Lobene Modified Gingival Index was calculated by summing the scores and dividing by the number of sites graded (excludes missing teeth & sites not graded). Whole mouth average can range from 0 (normal) to 4 (severe inflammation).
For each tooth, six gingival areas (distobuccal, buccal, mesiobuccal, mesiolingual, lingual, and distolingual) were scored using the following scale: 0=Normal (Absence of inflammation, 1=Mild inflammation (slight change in color, little change in texture) of any portion of but not the entire marginal or papillary gingival unit, 2=Mild inflammation criteria as above but involving the entire marginal or papillary gingival unit, 3=Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the marginal or papillary gingival unit, 4=Severe inflammation (marked redness, edema and/or hypertrophy, spontaneous bleeding or ulceration) of the marginal or papillary gingival unit.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00855933
|United States, Texas|
|Dr. Geza Terézhalmy, DDS , MA|
|San Antonio, Texas, United States, 78229|
|Luis R. Archila, DDS|
|Guatemala City, Guatemala|
|Study Director:||Aaron Biesbrock, DMD, PhD||Procter and Gamble|