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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04057430
Enrollment
40
Registered
2019-08-15
Start date
2016-12-10
Completion date
2017-02-26
Last updated
2019-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingivitis, Plaque

Keywords

Interdental plaque, Flossing aid, Children, Gingival inflammation

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.

Interventions

DEVICEGumChucks

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.

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

Sponsors

University of California, Los Angeles
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Years to 15 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Interdental plaque score - after first useBaseline and Day 1Interdental 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 usageBaseline and 4 weeksInterdental 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 usageBaseline and 4 weeksGingival 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 speedDay 1The total time for a participant to floss all interdental contacts was measured in seconds.

Secondary

MeasureTime frameDescription
Floss preferences by children, parents and dentistsDay 1Preferences 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026