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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

Tracking Information
First Submitted Date  ICMJE August 12, 2019
First Posted Date  ICMJE August 15, 2019
Last Update Posted Date August 15, 2019
Actual Study Start Date  ICMJE December 10, 2016
Actual Primary Completion Date February 26, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2019)
  • 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.
  • 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.
  • 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
  • Flossing speed [ Time Frame: Day 1 ]
    The total time for a participant to floss all interdental contacts was measured in seconds.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2019)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of the GumChucks® Flossing System Compared to String Floss for Interdental Plaque Removal in Children
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Gingivitis
  • Plaque
Intervention  ICMJE
  • 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.
  • Device: String floss
    Traditional string floss used in this study was Oral-B Glide® Pro-Health Original Floss
Study Arms  ICMJE
  • Active Comparator: String floss
    Intervention: Device: String floss
  • Experimental: Gumchucks floss
    Intervention: Device: GumChucks
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 13, 2019)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 26, 2017
Actual Primary Completion Date February 26, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04057430
Other Study ID Numbers  ICMJE GumChucksEfficacy
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nini Chaichanasakul Tran, DDS, PhD, University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of California, Los Angeles
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP