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Effect of a Multi-directional Power Toothbrush on Recession

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ClinicalTrials.gov Identifier: NCT02530671
Recruitment Status : Completed
First Posted : August 21, 2015
Results First Posted : October 19, 2015
Last Update Posted : April 27, 2016
Sponsor:
Collaborator:
Procter and Gamble
Information provided by (Responsible Party):
Sonja Sälzer, University Hospital Schleswig-Holstein

Study Description
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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.


Condition or disease Intervention/treatment Phase
Gingival Recession Device: Toothbrushing with manual toothbrush Device: Toothbrushing with power toothbrush Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Study Start Date : June 2011
Actual Primary Completion Date : June 2012
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Gingival Recession at Sites With Preexisting Recessions ≥2mm [ Time Frame: 12 months ]
  2. Bristle Splay Index (BSI) After a Specific Time-of-use [ Time Frame: 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).


Secondary Outcome Measures :
  1. Recession at All Buccal Sites [ Time Frame: 12 months ]
  2. Percentage of Recession Sites Demonstrating a Change of ≥1mm [ Time Frame: 12 months ]
  3. Pocket Probing Depths at 12months [ Time Frame: 12 months ]
  4. Comparison of BSI Between Periods [ Time Frame: 0-3, 9-12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Sonja Sälzer, Dr. Sonja Sälzer, University Hospital Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT02530671    
Other Study ID Numbers: 2011015
First Posted: August 21, 2015    Key Record Dates
Results First Posted: October 19, 2015
Last Update Posted: April 27, 2016
Last Verified: March 2016
Keywords provided by Sonja Sälzer, University Hospital Schleswig-Holstein:
multi-directional power toothbrush
manual toothbrush
Additional relevant MeSH terms:
Layout table for MeSH terms
Gingival Recession
Gingival Diseases
Periodontal Diseases
 Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy