An interventional study of Tooth brush without nylon bristles and Tooth brush with soft nylon bristles in Gingival Recession, sponsored by Western University of Health Sciences. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-05-10.
Sponsored by Western University of Health Sciences · Not applicable, Interventional, and Prevention
This study tests if a bristle-less tooth brush has any measurable effect on gum recession in patients who are seen regularly for preventive dental care compared to a regular soft tooth-brush.
Subjects are recruited from patients attending the Western University of Health Sciences Dental Center and asked to continue regular preventive dental care while using either the test or control brush for a year and using floss and toothpaste supplied by the researchers. The exams include measurement of plaque, pockets and gum recession every 3 months, and involve photographs and impressions of the teeth and gums to record any changes that occur.
Purpose: This randomized clinical trial tested if a novel bristle-less tooth brush design is more effective in preventing gingival recession in adults receiving periodontal maintenance than a soft tooth brush with nylon bristles.
Materials and methods: The investigators will recruit 23 subjects with gingival recession who received regular periodontal maintenance care at Western University of Health Sciences Dental Center, and who did not exhibit signs of acute dental and systemic disease, occlusal discrepancies and parafunctional habits. The investigators will randomly assign these subjects to two groups, one using a soft nylon-bristled tooth brush, and the other group using the experimental tooth brush that contains a brush head with short, soft, rubbery cones. Both groups will receive regular maintenance and periodontal exams by blinded examiners every 3-4 months measuring probing depth, bleeding on probing, plaque indices, and gingival recession. In addition, gingival recession will also be determined using a measuring guide on study models obtained with polyvinylsiloxane impressions. For added control of confounding variables, both groups will be supplied with abrasivity tooth paste and waxed floss while receiving repeated oral hygiene instruction and phone follow-up.
402 studies on the registry are indexed under Gingival Recession; 98 are open to participants now.
This study's enrollment of 23 is below the median of 30 across 368 interventional studies indexed under Gingival Recession.
Browse Gingival Recession studies →Western University of Health Sciences is the lead sponsor of 21 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will be assigned to use a bristle-less manual tooth brush with short, rubbery cones for one year twice daily
Other: Tooth brush without nylon bristles
Subjects will be assigned to use a soft, nylon-bristled tooth brush for one year twice daily
Other: Tooth brush with soft nylon bristles
Subjects will use a bristle-less tooth brush. Subjects in both arms of the study will use the same waxed, mint-flavored floss; baking-soda based tooth paste; exams and professional tooth cleaning every 3-4 months; oral hygiene instruction every 3-4 months
Also known as: PeriClean Toothbrush
Subjects will use a soft bristled tooth brush. Subjects in both arms of the study will use the same waxed, mint-flavored floss; baking-soda based tooth paste; exams and professional tooth cleaning every 3-4 months; oral hygiene instruction every 3-4 months
Also known as: Oral B soft brush
Gingival Recession (Distance between cemento-enamel junction and gingival margin as measured in millimeters)
Gingival recession will be measured at the line angle and mid-facial or mid-lingual of each tooth with exposed tooth roots.
Time frame: About 1 year
Plaque level
Oral plaque level as recorded using the Quigley-Hein index as modified by Turesky
Time frame: About 1 year
Gingival bleeding on probing
% bleeding sites on probing (6 sites per tooth). Gingival bleeding is a measure of gingival inflammation, which needs to stay minimal no matter what tooth brush is used.
Time frame: About 1 year
Probing depth (distance from gingival margin to floor of periodontal sulcus in millimeters)
This is another measure of periodontal inflammation and sign of gum disease, as well as effectiveness of brush in preventing plaque buildup and development of periodontal disease.
Time frame: About 1 year
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Western University of Health Sciences