GumChucks vs Interdental Brushes in Plaque Removal.

NCT07140068 | Completed

• 1 other identifier: 2023-H-0120-D-M-0527
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study compared two ways of cleaning between the teeth, Gumchucks (a new handled dental flossing system) and interdental brushes, in Lebanese adolescents aged 10-15 years. Plaque is a soft layer of bacteria that can build up between teeth and cause tooth decay and gum problems. Toothbrushing alone cannot always clean these spaces. Extra cleaning tools, such as floss or interdental brushes, are recommended. Gumchucks uses two small handles to hold the floss, making it easier to use, especially for children. It had not previously been directly compared with interdental brushes in this age group. In this study, 60 healthy adolescents were included to use Gumchucks on one side of their mouth and interdental brushes on the other side for six months. They were asked to clean twice daily after toothbrushing. Researchers measured plaque levels between teeth, gum bleeding, time taken to clean, and which method participants and parents preferred The goal was to find out which method worked better and was preferred, to help dentists recommend the best way for young people to keep their teeth and gums healthy.

Conditions

Healthy; Adolescent; Dental Plaque; Gingivitis; Oral Hygiene; Pediatric Dentistry

Keywords

Dental plaque; Gingivitis; Oral hygiene; Flossing; Interdental brushes; Interdental cleaning; Dental floss; Oral health; Preventive dentistry; Adolescents

Outcome Measures

Primary Outcomes (2)

• Interdental plaque removal

  Evaluated by measuring the modified Quigley-Hein plaque index scores (by Turesky et al., 1970) after using a plaque disclosing agent.

  Baseline, 1 month, 3 months, and 6 months.

• Gingival inflammation reduction

  Evaluated by measuring the papillary bleeding index (PBI) scores (by Mühlemann, 1977).

  Baseline, 1 month, 3 months, and 6 months.

Secondary Outcomes (2)

• Cleaning time

  Dental Prophylaxis Session, 3 days before the Baseline examination session

• Participant and Parent Preferences.

  Dental Prophylaxis Session, 3 days before the Baseline examination session

Study Arms (2)

GumChucks Flossing System

EXPERIMENTAL

Participants cleaned all interdental spaces on one side of the mouth using the handled flossing system (GumChucks®) twice daily after toothbrushing with a medium- bristle toothbrush and fluoride toothpaste. The proper C-shape flossing technique was demonstrated, and written instructions were provided.

Device: Handled dental flossing system (GumChucks®)

Interdental Brush

EXPERIMENTAL

Participants cleaned all interdental spaces on the other side of the mouth using appropriately sized interdental brushes twice daily after toothbrushing with a medium-bristle toothbrush and fluoride toothpaste. Proper technique was demonstrated, and written instructions were provided.

Device: Interdental Brush

Interventions

Handled dental flossing system (GumChucks®) DEVICE

Handled dental flossing system (GumChucks®) designed for easier C-shape flossing. Participants were instructed to clean all interdental spaces on the assigned side twice daily after toothbrushing with fluoride toothpaste using a medium-bristle toothbrush. Proper technique was demonstrated and written instructions provided.

GumChucks Flossing System

Interdental Brush DEVICE

Appropriately sized interdental brushes for cleaning interdental spaces on the assigned side. Participants were instructed to clean twice daily after toothbrushing with fluoride toothpaste using a medium-bristle toothbrush. Proper technique was demonstrated and written instructions provided.

Interdental Brush

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy adolescents (ASA 1) aged between 10 and 15 years;
• Patients who had at least 4 posterior interdental contacts;
• Patients who were able to follow verbal and/or written instructions, where they were asked to perform what they understood directly after reading the written instructions and listening to the explanation.

You may not qualify if:

• Patients who had antibiotics within the last 6 months;
• Patients who were using antibacterial mouth rinses;
• Patients with physical, intellectual, developmental, or emotional disabilities;
• Patients with unilateral mastication or a nonfunctional side.

Sponsors & Collaborators

• Beirut Arab University: lead

Study Sites (1)

Beirut Arab University

Beirut, Tarik El Jadida, 11-50-20, Lebanon

Location

MeSH Terms

Conditions

Dental Plaque; Gingivitis

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases

Study Officials

• Rim K Daher, Masters

  Beirut Arab University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor was blinded to which side of each participant's mouth received the handled flossing system or interdental brush. Participants and care providers were not masked due to the visible nature of the interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Pediatric Dentistry Resident

Model Details: Randomized controlled trial using a split-mouth design, where each participant's mouth was divided into two halves, one side assigned to the GumChucks flossing system and the other side to interdental brushes.

Study Record Dates

• First Submitted: August 16, 2025
• First Posted: August 24, 2025
• Study Start: November 21, 2022
• Primary Completion: November 10, 2023
• Study Completion: November 10, 2023
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)