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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 23
- Primary Endpoint
- Gingival Recession (Distance between cemento-enamel junction and gingival margin as measured in millimeters)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •receive regular periodontal treatment at the Western University of Health Sciences Dental Center
- •have facial gingival recession with at least 1 mm clinical attachment loss in the anterior region of their mouths
Exclusion Criteria
- •unable to provide consent
- •had severe uncontrolled medical conditions resulting in an American Society of Anesthesiologist's Physical Status Class greater than 3
- •acute pain or infection
- •caries near the gingival margin
- •restorations covering the gingival recession defect
- •presence of Miller Class III or IV defects
- •severe or aggressive periodontitis
- •missing more than one anterior tooth
- •severe malocclusion
- •presence of occlusal trauma requiring more than limited adjustment
- •Tobacco use
- •ongoing or planned orthodontic therapy
- •oral piercings
- •history of bruxism, clenching, nail biting, holding pins with teeth, or gum scratching habits
- •preferred use of an electric tooth brush over a manual brush
Arms & Interventions
Bristle-less brush
Subjects will be assigned to use a bristle-less manual tooth brush with short, rubbery cones for one year twice daily
Intervention: Tooth brush without nylon bristles (Other)
Soft bristle brush
Subjects will be assigned to use a soft, nylon-bristled tooth brush for one year twice daily
Intervention: Tooth brush with soft nylon bristles (Other)
Outcomes
Primary Outcomes
Gingival Recession (Distance between cemento-enamel junction and gingival margin as measured in millimeters)
Time Frame: About 1 year
Gingival recession will be measured at the line angle and mid-facial or mid-lingual of each tooth with exposed tooth roots.
Secondary Outcomes
- Gingival bleeding on probing(About 1 year)
- Plaque level(About 1 year)
- Probing depth (distance from gingival margin to floor of periodontal sulcus in millimeters)(About 1 year)
Investigators
Tobias K. Boehm, DDS,PhD
Associate Professor
Western University of Health Sciences