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Completed

NCT Number: NCT07140068

GumChucks vs Interdental Brushes in Plaque Removal.

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.

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Key information

Age range

10 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beirut Arab University

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Interdental plaque removal

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

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

  2. Gingival inflammation reduction

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

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

Secondary outcomes

  1. Cleaning time

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

    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.

  2. Participant and Parent Preferences.

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

    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.

Sponsors and collaborators

Lead sponsor

Beirut Arab University

Other

Registry information

Official study title

Comparing GumChucks Flossing System and Interdental Brushes in Plaque Removal Efficacy Among Lebanese Adolescents (A Randomized Controlled Trial).

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 24, 2025
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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