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

Not Applicable

Completed

• Conditions: Gingivitis; Plaque
• Interventions: Device: String floss; Device: GumChucks

• Registration Number: NCT04057430
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-10
• Primary Completion: 2017-02-26
• Study Completion: 2017-02-26
• Status Verified: 2019-08
• Study First Submitted: 2019-08-12
• Study First Submitted QC: 2019-08-13
• Last Update Submitted: 2019-08-13
• Study First Posted: 2019-08-15
• Last Update Posted: 2019-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
String floss	String floss	-
Gumchucks floss	GumChucks	-

Primary Outcome Measures

Name	Time	Method
Interdental plaque score - after 4 weeks of usage	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.
Interdental plaque score - after first use	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.
Gingival index - after 4 weeks of usage	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	Day 1	The total time for a participant to floss all interdental contacts was measured in seconds.

Secondary Outcome Measures

Name	Time	Method
Floss preferences by children, parents and dentists	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.