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

NCT04057430 | Completed

• 1 other identifier: GumChucksEfficacy
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gingivitis; Plaque

Keywords

Interdental plaque; Flossing aid; Children; Gingival inflammation

Outcome Measures

Primary Outcomes (4)

• 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 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

  Baseline and 4 weeks

• Flossing speed

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

  Day 1

Secondary Outcomes (1)

• Floss preferences by children, parents and dentists

  Day 1

Study Arms (2)

String floss

ACTIVE COMPARATOR

Device: String floss

Gumchucks floss

EXPERIMENTAL

Device: GumChucks

Interventions

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.

Gumchucks floss

String floss DEVICE

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

String floss

Eligibility Criteria

• Age: 4 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Los Angeles: lead

MeSH Terms

Conditions

Gingivitis; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: August 15, 2019
• Study Start: December 10, 2016
• Primary Completion: February 26, 2017
• Study Completion: February 26, 2017
• Last Updated: August 15, 2019

Record last verified: 2019-08