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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
University Hospital Schleswig-Holstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gingival Recession focused on measuring multi-directional power toothbrush, manual toothbrush

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    August 18, 2015
    Last Updated
    March 24, 2016
    Sponsor
    University Hospital Schleswig-Holstein
    Collaborators
    Procter and Gamble
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    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

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    Effect of a Multi-directional Power Toothbrush on Recession

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