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

Gingivitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04057430
• Other study ID #: GumChucksEfficacy
• Status: Completed
• Phase: N/A
• Start date: December 10, 2016
• Est. completion date: February 26, 2017

Study information

• Verified date: August 2019
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 26, 2017
• Est. primary completion date: February 26, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingivitis
• Plaque

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Flossing speed	The total time for a participant to floss all interdental contacts was measured in seconds.	Day 1
Secondary	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