Effect of a Multi-directional Power Toothbrush on Recession
Primary Purpose
Gingival Recession
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Toothbrushing with manual toothbrush
Toothbrushing with power toothbrush
Sponsored by
About this trial
This is an interventional prevention trial for Gingival Recession focused on measuring multi-directional power toothbrush, manual toothbrush
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Manual toothbrush
Power toothbrush
Arm Description
ADA reference manual toothbrush
Multi-directional power toothbrush
Outcomes
Primary Outcome Measures
Gingival Recession at Sites With Preexisting Recessions ≥2mm
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).
Secondary Outcome Measures
Recession at All Buccal Sites
Percentage of Recession Sites Demonstrating a Change of ≥1mm
Pocket Probing Depths at 12months
Comparison of BSI Between Periods
Full Information
NCT ID
NCT02530671
First Posted
August 18, 2015
Last Updated
March 24, 2016
Sponsor
University Hospital Schleswig-Holstein
Collaborators
Procter and Gamble
1. Study Identification
Unique Protocol Identification Number
NCT02530671
Brief Title
Effect of a Multi-directional Power Toothbrush on Recession
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 Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Schleswig-Holstein
Collaborators
Procter and Gamble
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
multi-directional power toothbrush, manual toothbrush
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Manual toothbrush
Arm Type
Active Comparator
Arm Description
ADA reference manual toothbrush
Arm Title
Power toothbrush
Arm Type
Experimental
Arm Description
Multi-directional power toothbrush
Intervention Type
Device
Intervention Name(s)
Toothbrushing with manual toothbrush
Intervention Type
Device
Intervention Name(s)
Toothbrushing with power toothbrush
Primary Outcome Measure Information:
Title
Gingival Recession at Sites With Preexisting Recessions ≥2mm
Time Frame
12 months
Title
Bristle Splay Index (BSI) After a Specific Time-of-use
Description
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).
Time Frame
3, 6, 9 and 12 months
Secondary Outcome Measure Information:
Title
Recession at All Buccal Sites
Time Frame
12 months
Title
Percentage of Recession Sites Demonstrating a Change of ≥1mm
Time Frame
12 months
Title
Pocket Probing Depths at 12months
Time Frame
12 months
Title
Comparison of BSI Between Periods
Time Frame
0-3, 9-12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
12. IPD Sharing Statement
Learn more about this trial
Effect of a Multi-directional Power Toothbrush on Recession
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