Clinical Trials Directory

Trials / Completed

CompletedNCT07140068

GumChucks vs Interdental Brushes in Plaque Removal.

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Beirut Arab University · Academic / Other
Sex
All
Age
10 Years – 15 Years
Healthy volunteers
Accepted

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.

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.

Conditions

Interventions

TypeNameDescription
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 BrushAppropriately 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.

Timeline

Start date
2022-11-21
Primary completion
2023-11-10
Completion
2023-11-10
First posted
2025-08-24
Last updated
2025-08-24

Locations

1 site across 1 country: Lebanon

Source: ClinicalTrials.gov record NCT07140068. Inclusion in this directory is not an endorsement.