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Effectiveness of the GumChucks® Flossing System Compared to String Floss for Interdental Plaque Removal in Children

Primary Purpose

Gingivitis, Plaque

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
GumChucks
String floss
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gingivitis focused on measuring Interdental plaque, Flossing aid, Children, Gingival inflammation

Eligibility Criteria

4 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy children aged 4-15 years, who were not on any type of medication
  • presence of at least 4 posterior interdental contacts
  • ability to follow verbal and/or written instruction
  • availability for a 4-week study period
  • one parent or legal guardian of each included child participant.

Exclusion Criteria:

  • had antibiotics within the last 6 months
  • are pregnant.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    String floss

    Gumchucks floss

    Arm Description

    Outcomes

    Primary Outcome Measures

    Interdental plaque score - after first use
    Interdental plaque scores were recorded after the teeth were stained with plaque disclosing solutions (GUM® Red-Cote®) for 30 seconds followed by a water rinse. Interdental plaque was scored either presence or absence at 4 sites of each tooth (mesio-buccal, disto-buccal, mesio-lingual, and disto-lingual). Score of 0 = If disclosing solution shows no visible plaque at the site Score of 1 = if disclosing solution shows the presence of any plaque between interproximal contact and the respective line angle of that site. The total interdental plaque score for each participant is the sum of all sites stained positive with disclosing solution.
    Interdental plaque score - after 4 weeks of usage
    Interdental plaque scores were recorded after the teeth were stained with plaque disclosing solutions (GUM® Red-Cote®) for 30 seconds followed by a water rinse. Interdental plaque was scored either presence or absence at 4 sites of each tooth (mesio-buccal, disto-buccal, mesio-lingual, and disto-lingual). Score of 0 = If disclosing solution shows no visible plaque at the site Score of 1 = if disclosing solution shows the presence of any plaque between interproximal contact and the respective line angle of that site.
    Gingival index - after 4 weeks of usage
    Gingival inflammation was assessed using the gingival index where the scores were taken of the buccal and lingual margins of the interdental papillae adjacent to interdental contacts with the following scoring system: 0 = absence of inflammation = mild inflammation: slight change in color, little change in texture = moderate inflammation: moderate erythema/edema, bleeding on pressure = severe inflammation: severe erythema/edema, tendency to spontaneous bleeding, ulceration The gingival index score of each participant is the sum of all scores divided by the total numbers of buccal and lingual interdental papillae sites
    Flossing speed
    The total time for a participant to floss all interdental contacts was measured in seconds.

    Secondary Outcome Measures

    Floss preferences by children, parents and dentists
    Preferences of child participants, their parents and dentists toward the use of GumChucks® in comparison to string floss was measured by a 5-point Likert scale questionnaire. Child participants and their parents completed questionnaires after using both flossing products, while dentists completed questionnaires after viewing the video and/or live demonstration of GumChucks® usage on a model of the oral cavity.

    Full Information

    First Posted
    August 12, 2019
    Last Updated
    August 13, 2019
    Sponsor
    University of California, Los Angeles
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04057430
    Brief Title
    Effectiveness of the GumChucks® Flossing System Compared to String Floss for Interdental Plaque Removal in Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    December 10, 2016 (Actual)
    Primary Completion Date
    February 26, 2017 (Actual)
    Study Completion Date
    February 26, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of California, Los Angeles

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This study evaluates the interdental plaque removal efficacy, flossing speed, and reduction in gingival inflammation of a new flossing system (GumChucks®) compared to string floss, and to assess preference between the two flossing products in children, parents, and dentists.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingivitis, Plaque
    Keywords
    Interdental plaque, Flossing aid, Children, Gingival inflammation

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    String floss
    Arm Type
    Active Comparator
    Arm Title
    Gumchucks floss
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    GumChucks
    Intervention Description
    GumChucks® is an innovative flossing system resembling mini nunchucks. The two-handle design eliminates the need to wrap the floss around fingers, and a proper flossing technique is facilitated by the nature of its curved shaped.
    Intervention Type
    Device
    Intervention Name(s)
    String floss
    Intervention Description
    Traditional string floss used in this study was Oral-B Glide® Pro-Health Original Floss
    Primary Outcome Measure Information:
    Title
    Interdental plaque score - after first use
    Description
    Interdental plaque scores were recorded after the teeth were stained with plaque disclosing solutions (GUM® Red-Cote®) for 30 seconds followed by a water rinse. Interdental plaque was scored either presence or absence at 4 sites of each tooth (mesio-buccal, disto-buccal, mesio-lingual, and disto-lingual). Score of 0 = If disclosing solution shows no visible plaque at the site Score of 1 = if disclosing solution shows the presence of any plaque between interproximal contact and the respective line angle of that site. The total interdental plaque score for each participant is the sum of all sites stained positive with disclosing solution.
    Time Frame
    Baseline and Day 1
    Title
    Interdental plaque score - after 4 weeks of usage
    Description
    Interdental plaque scores were recorded after the teeth were stained with plaque disclosing solutions (GUM® Red-Cote®) for 30 seconds followed by a water rinse. Interdental plaque was scored either presence or absence at 4 sites of each tooth (mesio-buccal, disto-buccal, mesio-lingual, and disto-lingual). Score of 0 = If disclosing solution shows no visible plaque at the site Score of 1 = if disclosing solution shows the presence of any plaque between interproximal contact and the respective line angle of that site.
    Time Frame
    Baseline and 4 weeks
    Title
    Gingival index - after 4 weeks of usage
    Description
    Gingival inflammation was assessed using the gingival index where the scores were taken of the buccal and lingual margins of the interdental papillae adjacent to interdental contacts with the following scoring system: 0 = absence of inflammation = mild inflammation: slight change in color, little change in texture = moderate inflammation: moderate erythema/edema, bleeding on pressure = severe inflammation: severe erythema/edema, tendency to spontaneous bleeding, ulceration The gingival index score of each participant is the sum of all scores divided by the total numbers of buccal and lingual interdental papillae sites
    Time Frame
    Baseline and 4 weeks
    Title
    Flossing speed
    Description
    The total time for a participant to floss all interdental contacts was measured in seconds.
    Time Frame
    Day 1
    Secondary Outcome Measure Information:
    Title
    Floss preferences by children, parents and dentists
    Description
    Preferences of child participants, their parents and dentists toward the use of GumChucks® in comparison to string floss was measured by a 5-point Likert scale questionnaire. Child participants and their parents completed questionnaires after using both flossing products, while dentists completed questionnaires after viewing the video and/or live demonstration of GumChucks® usage on a model of the oral cavity.
    Time Frame
    Day 1

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: healthy children aged 4-15 years, who were not on any type of medication presence of at least 4 posterior interdental contacts ability to follow verbal and/or written instruction availability for a 4-week study period one parent or legal guardian of each included child participant. Exclusion Criteria: had antibiotics within the last 6 months are pregnant.

    12. IPD Sharing Statement

    Learn more about this trial

    Effectiveness of the GumChucks® Flossing System Compared to String Floss for Interdental Plaque Removal in Children

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