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.

Study Overview

• Status: Completed
• Conditions: Gingivitis; Plaque
• Intervention / Treatment: Device: String floss; Device: GumChucks

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 15 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interdental plaque score - after first use	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.	Baseline and Day 1
Interdental plaque score - after 4 weeks of usage	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.	Baseline and 4 weeks
Gingival index - after 4 weeks of usage	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	Baseline and 4 weeks
Flossing speed	The total time for a participant to floss all interdental contacts was measured in seconds.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Floss preferences by children, parents and dentists	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.	Day 1

Collaborators and Investigators

• Sponsor: University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 10, 2016
• Primary Completion (ACTUAL): February 26, 2017
• Study Completion (ACTUAL): February 26, 2017

Study Registration Dates

• First Submitted: August 12, 2019
• First Submitted That Met QC Criteria: August 13, 2019
• First Posted (ACTUAL): August 15, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 15, 2019
• Last Update Submitted That Met QC Criteria: August 13, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Children; Interdental plaque; Flossing aid; Gingival inflammation
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis
• Other Study ID Numbers: GumChucksEfficacy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No