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

NCT ID: NCT02951065

Last Updated: 2017-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2017-04-10

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.

Conditions

Gingival Recession

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Bristle-less brush

Subjects will be assigned to use a bristle-less manual tooth brush with short, rubbery cones for one year twice daily

Group Type: EXPERIMENTAL

Tooth brush without nylon bristles

Intervention Type: OTHER

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

Soft bristle brush

Subjects will be assigned to use a soft, nylon-bristled tooth brush for one year twice daily

Group Type: ACTIVE_COMPARATOR

Tooth brush with soft nylon bristles

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Other Intervention Names

PeriClean Toothbrush; Oral B soft brush

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peri-Swab, LLC

INDUSTRY

Sponsor Role: collaborator

Western University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Tobias K. Boehm, DDS,PhD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

WUCDM 1 2016

Identifier Type: -

Identifier Source: org_study_id