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

NCT ID: NCT04057430

Last Updated: 2019-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-10

Study Completion Date

2017-02-26

Brief Summary

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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

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Conditions

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Gingivitis Plaque

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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String floss

Group Type ACTIVE_COMPARATOR

String floss

Intervention Type DEVICE

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

Gumchucks floss

Group Type EXPERIMENTAL

GumChucks

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

String floss

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Nini Chaichanasakul Tran, DDS, PhD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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GumChucksEfficacy

Identifier Type: -

Identifier Source: org_study_id

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