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Effect of Bristle-less Toothbrush (PeriClean) on Gum Recession

Primary Purpose

Gingival Recession

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tooth brush without nylon bristles
Tooth brush with soft nylon bristles
Sponsored by
Western University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gingival Recession

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • receive regular periodontal treatment at the Western University of Health Sciences Dental Center
  • have facial gingival recession with at least 1 mm clinical attachment loss in the anterior region of their mouths

Exclusion Criteria:

  • unable to provide consent
  • had severe uncontrolled medical conditions resulting in an American Society of Anesthesiologist's Physical Status Class greater than 3
  • acute pain or infection
  • caries near the gingival margin
  • restorations covering the gingival recession defect
  • presence of Miller Class III or IV defects
  • severe or aggressive periodontitis
  • missing more than one anterior tooth
  • severe malocclusion
  • presence of occlusal trauma requiring more than limited adjustment
  • Tobacco use
  • ongoing or planned orthodontic therapy
  • oral piercings
  • history of bruxism, clenching, nail biting, holding pins with teeth, or gum scratching habits
  • preferred use of an electric tooth brush over a manual brush

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Bristle-less brush

    Soft bristle brush

    Arm Description

    Subjects will be assigned to use a bristle-less manual tooth brush with short, rubbery cones for one year twice daily

    Subjects will be assigned to use a soft, nylon-bristled tooth brush for one year twice daily

    Outcomes

    Primary Outcome Measures

    Gingival Recession (Distance between cemento-enamel junction and gingival margin as measured in millimeters)
    Gingival recession will be measured at the line angle and mid-facial or mid-lingual of each tooth with exposed tooth roots.

    Secondary Outcome Measures

    Plaque level
    Oral plaque level as recorded using the Quigley-Hein index as modified by Turesky
    Gingival bleeding on probing
    % bleeding sites on probing (6 sites per tooth). Gingival bleeding is a measure of gingival inflammation, which needs to stay minimal no matter what tooth brush is used.
    Probing depth (distance from gingival margin to floor of periodontal sulcus in millimeters)
    This is another measure of periodontal inflammation and sign of gum disease, as well as effectiveness of brush in preventing plaque buildup and development of periodontal disease.

    Full Information

    First Posted
    October 27, 2016
    Last Updated
    May 8, 2017
    Sponsor
    Western University of Health Sciences
    Collaborators
    Peri-Swab, LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02951065
    Brief Title
    Effect of Bristle-less Toothbrush (PeriClean) on Gum Recession
    Official Title
    A Pilot Randomized Clinical Trial of a Manual Bristle-less Tooth Brush Demonstrates Slight Improvement in Gingival Recession Compared to a Conventional Soft Manual Brush
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2015 (undefined)
    Primary Completion Date
    February 15, 2017 (Actual)
    Study Completion Date
    April 10, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Western University of Health Sciences
    Collaborators
    Peri-Swab, LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study tests if a bristle-less tooth brush has any measurable effect on gum recession in patients who are seen regularly for preventive dental care compared to a regular soft tooth-brush. Subjects are recruited from patients attending the Western University of Health Sciences Dental Center and asked to continue regular preventive dental care while using either the test or control brush for a year and using floss and toothpaste supplied by the researchers. The exams include measurement of plaque, pockets and gum recession every 3 months, and involve photographs and impressions of the teeth and gums to record any changes that occur.
    Detailed Description
    Purpose: This randomized clinical trial tested if a novel bristle-less tooth brush design is more effective in preventing gingival recession in adults receiving periodontal maintenance than a soft tooth brush with nylon bristles. Materials and methods: The investigators will recruit 23 subjects with gingival recession who received regular periodontal maintenance care at Western University of Health Sciences Dental Center, and who did not exhibit signs of acute dental and systemic disease, occlusal discrepancies and parafunctional habits. The investigators will randomly assign these subjects to two groups, one using a soft nylon-bristled tooth brush, and the other group using the experimental tooth brush that contains a brush head with short, soft, rubbery cones. Both groups will receive regular maintenance and periodontal exams by blinded examiners every 3-4 months measuring probing depth, bleeding on probing, plaque indices, and gingival recession. In addition, gingival recession will also be determined using a measuring guide on study models obtained with polyvinylsiloxane impressions. For added control of confounding variables, both groups will be supplied with abrasivity tooth paste and waxed floss while receiving repeated oral hygiene instruction and phone follow-up.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingival Recession

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    23 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Bristle-less brush
    Arm Type
    Experimental
    Arm Description
    Subjects will be assigned to use a bristle-less manual tooth brush with short, rubbery cones for one year twice daily
    Arm Title
    Soft bristle brush
    Arm Type
    Active Comparator
    Arm Description
    Subjects will be assigned to use a soft, nylon-bristled tooth brush for one year twice daily
    Intervention Type
    Other
    Intervention Name(s)
    Tooth brush without nylon bristles
    Other Intervention Name(s)
    PeriClean Toothbrush
    Intervention Description
    Subjects will use a bristle-less tooth brush. Subjects in both arms of the study will use the same waxed, mint-flavored floss; baking-soda based tooth paste; exams and professional tooth cleaning every 3-4 months; oral hygiene instruction every 3-4 months
    Intervention Type
    Other
    Intervention Name(s)
    Tooth brush with soft nylon bristles
    Other Intervention Name(s)
    Oral B soft brush
    Intervention Description
    Subjects will use a soft bristled tooth brush. Subjects in both arms of the study will use the same waxed, mint-flavored floss; baking-soda based tooth paste; exams and professional tooth cleaning every 3-4 months; oral hygiene instruction every 3-4 months
    Primary Outcome Measure Information:
    Title
    Gingival Recession (Distance between cemento-enamel junction and gingival margin as measured in millimeters)
    Description
    Gingival recession will be measured at the line angle and mid-facial or mid-lingual of each tooth with exposed tooth roots.
    Time Frame
    About 1 year
    Secondary Outcome Measure Information:
    Title
    Plaque level
    Description
    Oral plaque level as recorded using the Quigley-Hein index as modified by Turesky
    Time Frame
    About 1 year
    Title
    Gingival bleeding on probing
    Description
    % bleeding sites on probing (6 sites per tooth). Gingival bleeding is a measure of gingival inflammation, which needs to stay minimal no matter what tooth brush is used.
    Time Frame
    About 1 year
    Title
    Probing depth (distance from gingival margin to floor of periodontal sulcus in millimeters)
    Description
    This is another measure of periodontal inflammation and sign of gum disease, as well as effectiveness of brush in preventing plaque buildup and development of periodontal disease.
    Time Frame
    About 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: receive regular periodontal treatment at the Western University of Health Sciences Dental Center have facial gingival recession with at least 1 mm clinical attachment loss in the anterior region of their mouths Exclusion Criteria: unable to provide consent had severe uncontrolled medical conditions resulting in an American Society of Anesthesiologist's Physical Status Class greater than 3 acute pain or infection caries near the gingival margin restorations covering the gingival recession defect presence of Miller Class III or IV defects severe or aggressive periodontitis missing more than one anterior tooth severe malocclusion presence of occlusal trauma requiring more than limited adjustment Tobacco use ongoing or planned orthodontic therapy oral piercings history of bruxism, clenching, nail biting, holding pins with teeth, or gum scratching habits preferred use of an electric tooth brush over a manual brush

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effect of Bristle-less Toothbrush (PeriClean) on Gum Recession

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