Effect of a Multi-directional Power Toothbrush on Recession

Not Applicable

Completed

• Conditions: Gingival Recession
• Interventions: Device: Toothbrushing with power toothbrush; Device: Toothbrushing with manual toothbrush

• Registration Number: NCT02530671
• Lead Sponsor: University Hospital Schleswig-Holstein

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2012-06
• Study Completion: 2014-06
• Study First Submitted: 2015-08-18
• Study First Submitted QC: 2015-08-19
• Study First Posted: 2015-08-21
• Results First Submitted: 2015-08-26
• Results First Submitted QC: 2015-09-27
• Results First Posted: 2015-10-19
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2025-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Power toothbrush	Toothbrushing with power toothbrush	Multi-directional power toothbrush
Manual toothbrush	Toothbrushing with manual toothbrush	ADA reference manual toothbrush

Primary Outcome Measures

Name	Time	Method
Bristle Splay Index (BSI) After a Specific Time-of-use	3, 6, 9 and 12 months	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).
Gingival Recession at Sites With Preexisting Recessions ≥2mm	12 months

Secondary Outcome Measures

Name	Time	Method
Comparison of BSI Between Periods	0-3, 9-12 months
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