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

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ClinicalTrials.gov Identifier: NCT04057430
Recruitment Status : Completed
First Posted : August 15, 2019
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Nini Chaichanasakul Tran, DDS, PhD, University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
Gingivitis Plaque Device: GumChucks Device: String floss Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Actual Study Start Date : December 10, 2016
Actual Primary Completion Date : February 26, 2017
Actual Study Completion Date : February 26, 2017

Arm Intervention/treatment
Active Comparator: String floss Device: String floss
Traditional string floss used in this study was Oral-B Glide® Pro-Health Original Floss

Experimental: Gumchucks floss Device: GumChucks
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.




Primary Outcome Measures :
  1. Interdental plaque score - after first use [ Time Frame: Baseline and Day 1 ]

    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.


  2. Interdental plaque score - after 4 weeks of usage [ Time Frame: Baseline and 4 weeks ]

    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.


  3. Gingival index - after 4 weeks of usage [ Time Frame: Baseline and 4 weeks ]

    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

    1. = mild inflammation: slight change in color, little change in texture
    2. = moderate inflammation: moderate erythema/edema, bleeding on pressure
    3. = 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

  4. Flossing speed [ Time Frame: Day 1 ]
    The total time for a participant to floss all interdental contacts was measured in seconds.


Secondary Outcome Measures :
  1. Floss preferences by children, parents and dentists [ Time Frame: Day 1 ]
    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.



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Ages Eligible for Study:   4 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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Responsible Party: Nini Chaichanasakul Tran, DDS, PhD, Assistant Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04057430    
Other Study ID Numbers: GumChucksEfficacy
First Posted: August 15, 2019    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nini Chaichanasakul Tran, DDS, PhD, University of California, Los Angeles:
Interdental plaque
Flossing aid
Children
Gingival inflammation
Additional relevant MeSH terms:
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Gingivitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases