Effect of a Multi-directional Power Toothbrush on Recession

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

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.

Study Overview

• Status: Completed
• Conditions: Gingival Recession
• Intervention / Treatment: Device: Toothbrushing with manual toothbrush; Device: Toothbrushing with power toothbrush

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: University Hospital Schleswig-Holstein
• Collaborators: Procter and Gamble

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: August 18, 2015
• First Submitted That Met QC Criteria: August 19, 2015
• First Posted (Estimated): August 21, 2015

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: multi-directional power toothbrush; manual toothbrush
• Additional Relevant MeSH Terms: Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Gingival Diseases; Gingival Recession
• Other Study ID Numbers: 2011015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No