NCT02951065

Effect of Bristle-less Toothbrush (PeriClean) on Gum Recession

A Pilot Randomized Clinical Trial of a Manual Bristle-less Tooth Brush Demonstrates Slight Improvement in Gingival Recession Compared to a Conventional Soft Manual Brush

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Western University of Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Gingival Recession

Interventions

Type	Name	Description
OTHER	Tooth brush without 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
OTHER	Tooth brush with soft nylon bristles	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

Timeline

• Start date: 2015-03-01
• Primary completion: 2017-02-15
• Completion: 2017-04-10
• First posted: 2016-11-01
• Last updated: 2017-05-10