Effectiveness of the GumChucks® Flossing System Compared to String Floss for Interdental Plaque Removal in Children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Primary Endpoint
- Interdental plaque score - after 4 weeks of usage
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 4 Years to 15 Years (Child)
- Sex
- All
- Accepts 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.
Arms & Interventions
String floss
Intervention: String floss (Device)
Gumchucks floss
Intervention: GumChucks (Device)
Outcomes
Primary Outcomes
Interdental plaque score - after 4 weeks of usage
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Day 1
The total time for a participant to floss all interdental contacts was measured in seconds.
Secondary Outcomes
- Floss preferences by children, parents and dentists(Day 1)
Investigators
Nini Chaichanasakul Tran, DDS, PhD
Assistant Professor
University of California, Los Angeles