Clinical trial NCT02951065: Effect of Bristle-less Toothbrush (PeriClean) on Gum Recession
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Lead sponsor: Western University of Health Sciences
Sponsor class: OTHER
Collaborators: name: Peri-Swab, LLC
First posted: 2016-11-01
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gingival Recession (Distance between cemento-enamel junction and gingival margin as measured in millimeters)
timeFrame: About 1 year
Secondary outcomes:
measure: Plaque level
timeFrame: About 1 year
measure: Gingival bleeding on probing
timeFrame: About 1 year
measure: Probing depth (distance from gingival margin to floor of periodontal sulcus in millimeters)
timeFrame: About 1 year
Other outcomes:
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