Effect of a Multi-directional Power Toothbrush on Recession

Gingival Recession Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02530671
• Other study ID #: 2011015
• Status: Completed
• Phase: N/A
• First received: August 18, 2015
• Last updated: September 27, 2015
• Start date: June 2011

Study information

• Verified date: September 2015
• Source: University of Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 scorable teeth without orthodontic appliances or crowns and bridges

• at least 2 teeth showing recession of = 2 mm on the midbuccal 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Device:
• Toothbrushing with manual toothbrush

• Toothbrushing with power toothbrush

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Schleswig-Holstein	Procter and Gamble

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gingival Recession at Sites With Preexisting Recessions =2mm		12 months	No
Secondary	Recession at All Buccal Sites		12 months	No
Secondary	Percentage of Recession Sites Demonstrating a Change of =1mm		12 months	No
Secondary	Pocket Probing Depths at 12months		12 months	No