Effect of a Multi-directional Power Toothbrush on Recession

Study Overview
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Brief Summary
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Background: Clinical studies have explored the relationship between toothbrushing and the development of recession, but relevant recession data for the multi-directional power toothbrush (PT) are lacking. The aim of this study was to evaluate the effect of brushing with either a multi-directional power toothbrush (PT) or an ADA (American Dental Association) reference manual toothbrush (MT) on pre-existing mid-buccal gingival recession (Pre-GR) over 12 months Methods: This was a 12-month, prospective, single-blind, parallel-group, randomized controlled clinical study. Healthy participants without periodontitis but with at least 2 teeth showing Pre-GR ≥2mm were randomized to a group either brushing with a MT or a PT. The primary outcome parameter was the change at sites with Pre-GR ≥2mm. All recession measurements were performed by one calibrated examiner at baseline, 6 and 12 months. Secondary outcomes were changes of recession at all buccal sites (with or without pre-GR), changes in the percentage of recession sites demonstrating a change of ≥1mm as well as changes in pocket probing depths.

Official Title
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Effect of a Multi-directional Power and a Manual Toothbrush in Subjects Susceptible to Gingival Recession: A 12-month Randomized Controlled Clinical Study

Conditions
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Gingival Recession

Intervention / Treatment
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* Device: Toothbrushing with manual toothbrush
* Device: Toothbrushing with power toothbrush


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 scorable teeth without orthodontic appliances or crowns and bridges at least 2 teeth showing recession of ≥ 2 mm on the mid-buccal surfaces (high risk teeth) Exclusion Criteria: evidence of neglected dental health periodontitis and/or major hard/soft tissue lesions any physical limitations or restrictions potentially interfering with normal oral hygiene therapy with any drug within 28 days prior to the study pregnancy or breast feeding any systematic condition or significant illness

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Manual toothbrush<br>ADA reference manual toothbrush | Device: Toothbrushing with manual toothbrush<br> <br> |
| Experimental: Power toothbrush<br>Multi-directional power toothbrush | Device: Toothbrushing with power toothbrush<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingival Recession at Sites With Preexisting Recessions ≥2mm |  | 12 months | 
| Bristle Splay Index (BSI) After a Specific Time-of-use | A digital computer program (ImageJ, NIH, Bethesda, MD, USA) for evaluating the index was applied. All brushes were photographed from both top and side view in a standardized set-up including a benchmark (Lego GmbH (Gemeinschaft mit beschränkter Haft), Grasbrunn, Germany) as reference for measurement. Subsequently, an independent examiner (N.H.) measured the lengths twice. To devise the BSI formula the results were averaged and inserted. The formula is defined by: BSI (%) = ((a´- a)/a + (b´- b)/b + (c´- c)/c + (d´- d)/d)/4 x 100. BSI was standardized for usage time by dividing it by the number of days used (BSI/T). | 3, 6, 9 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recession at All Buccal Sites |  | 12 months | 
| Percentage of Recession Sites Demonstrating a Change of ≥1mm |  | 12 months | 
| Pocket Probing Depths at 12months |  | 12 months | 
| Comparison of BSI Between Periods |  | 0-3, 9-12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multi-directional power toothbrush, manual toothbrush