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CompletedNCT07140068Updated Aug 24, 2025

GumChucks vs Interdental Brushes in Plaque Removal.

An interventional study of Handled dental flossing system (GumChucks®) and Interdental Brush in Healthy, Adolescent and Dental Plaque, sponsored by Beirut Arab University. Completed at 1 site in Lebanon. Open to participants aged 10 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-24.

Sponsored by Beirut Arab University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 8 months after the study started (first participant enrolled Nov 2022, registered Aug 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
10 Years to 15 Years
Sex
All
01

Study 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.

Read the detailed description

This randomized, parallel, split-mouth, examiner-blind clinical trial compared Gumchucks, a handled dental flossing system, and interdental brushes in removing interdental plaque and reducing gingival inflammation in Lebanese adolescents.

Participants were 60 healthy adolescents aged 10-15 years, each with at least four posterior interdental contacts and no recent antibiotic or antibacterial mouth rinse use. In each participant, one side of the mouth was randomly assigned to Gumchucks and the other side to interdental brushing. Participants cleaned twice daily after brushing with fluoride toothpaste using a medium toothbrush.

During the first session, dental prophylaxis was performed, the correct size of interdental brush was selected for each participant, and demonstrations and written instructions for both devices were provided. The cleaning time was measured in seconds for each participant using each device, and the preferences were collected from participants and parents using 5-point Likert scale questionnaires at the end of the first session. Participants were then asked to avoid interdental cleaning for three days before the baseline assessment.

Clinical assessments performed at baseline, 1 month, 3 months, and 6 months included the Papillary Bleeding Index (PBI) (scored 0-4 at mesio-facial, disto-facial, mesio-lingual/palatal, and disto-lingual/palatal sites of interdental papillae) and the Quigley Hein Plaque Index (modified by Turesky): scored 0-5 at the same sites after using a plaque disclosing agent.

Intra- and inter-examiner reliability were evaluated using Cohen's Kappa statistics.

02

Conditions studied

  • 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
03

In context

Dental Plaque

314 studies on the registry are indexed under Dental Plaque; 54 are open to participants now.

This study's enrollment of 60 is close to the median of 59 across 279 interventional studies indexed under Dental Plaque.

Browse Dental Plaque studies →

Lead sponsor

Beirut Arab University is the lead sponsor of 16 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    GumChucks Flossing System

    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®)

  • Experimental
    Interdental Brush

    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

  • DeviceHandled dental flossing system (GumChucks®)

    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.

  • DeviceInterdental Brush

    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.

06

What researchers measure

Primary outcomes

  1. Interdental plaque removal

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

    Time frame: Baseline, 1 month, 3 months, and 6 months.

  2. Gingival inflammation reduction

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

    Time frame: Baseline, 1 month, 3 months, and 6 months.

Secondary outcomes

  1. Cleaning time

    Measured during the Dental Prophylaxis Session, after receiving the dental prophylaxis and the instructions on C-shape flossing with GumChucks and proper use of interdental brushes. The principal investigator recorded the total time for each participant to clean all interdental contacts on the phone's stopwatch in seconds, using both products each at a time, in front of a mirror.

    Time frame: Dental Prophylaxis Session, 3 days before the Baseline examination session

  2. Participant and Parent Preferences.

    Preferences toward the use of GumChucks in comparison to interdental brush were measured by a 5-point Likert scale questionnaire at the end of the Dental Prophylaxis Session, after using both products and measuring the cleaning time. The answers ranged between strongly disagree and strongly agree. The adolescent participants' questionnaire asked if GumChucks helped to clean interdentally faster and more frequently and if it was easier to use and more preferred over interdental brush. The parents' questionnaire asked if GumChucks was easier for their children as well as for them to help their children clean interdentally, if their children would clean interdentally more often, and if they would buy GumChucks for their children.

    Time frame: Dental Prophylaxis Session, 3 days before the Baseline examination session

07

Study locations

1 site
  • Beirut Arab University
    Beirut, Tarik El Jadida 11-50-20, Lebanon
08

References and documents

Individual participant data

Plan to share: No — This study will only share aggregate results, such as mean plaque scores, cleaning times, and preference percentages, in publications. Individual participant-level data (IPD) will not be shared.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07140068
Lead sponsor
Beirut Arab University
Responsible party
Rim Daher (Principal Investigator, Pediatric Dentistry Resident, Beirut Arab University) — Principal investigator
First posted
Aug 24, 2025
Start date
Nov 21, 2022
Primary completion
Nov 10, 2023
Completion
Nov 10, 2023
Last update
Aug 24, 2025

Study contacts

Rim K Daher, Masters
principal investigator · Beirut Arab University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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