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OpenTrials
Completed

NCT Number: NCT04057430

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

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.

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Key information

Conditions

Gingivitis Gingival Diseases Infections Mouth Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Periodontal Diseases Plaque Plaque, Amyloid Stomatognathic Diseases

Age range

4 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GumChucks

Device

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.

String Floss

Device

Traditional string floss used in this study was Oral-B Glide® Pro-Health Original Floss

Primary outcomes

  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

    • = 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

  4. Flossing speed

    Time frame: Day 1

    The total time for a participant to floss all interdental contacts was measured in seconds.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 15, 2019
Registry last updated
Aug 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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