Effect of a Multi-directional Power Toothbrush on Recession

NCT ID: NCT02530671

Last Updated: 2025-01-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2014-06-30

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.

Conditions

Gingival Recession

Study Design

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

Study Groups

Manual toothbrush

ADA reference manual toothbrush

Group Type: ACTIVE_COMPARATOR

Toothbrushing with manual toothbrush

Intervention Type: DEVICE

Power toothbrush

Multi-directional power toothbrush

Group Type: EXPERIMENTAL

Toothbrushing with power toothbrush

Intervention Type: DEVICE

Interventions

Toothbrushing with manual toothbrush

Intervention Type: DEVICE

Toothbrushing with power toothbrush

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Procter and Gamble

INDUSTRY

Sponsor Role: collaborator

University Hospital Schleswig-Holstein

OTHER

Sponsor Role: lead

Responsible Party

Sonja Sälzer

Dr. Sonja Sälzer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2011015

Identifier Type: -

Identifier Source: org_study_id