HealthyNCT07140068
GumChucks vs Interdental Brushes in Plaque Removal.
A study testing Handled dental flossing system (GumChucks®) and Interdental Brush in people with Healthy and Adolescent, run by Beirut Arab University at 1 site in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Adolescent, Dental Plaque
- What is being tested?
- Handled dental flossing system (GumChucks®) and Interdental Brush
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteLebanon
- Study dates
- 21 Nov 2022to 10 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing GumChucks Flossing System and Interdental Brushes in Plaque Removal Efficacy Among Lebanese Adolescents (A Randomized Controlled Trial).
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.
Read more
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.
- Conditions
- Healthy, Adolescent, Dental Plaque, Gingivitis, Oral Hygiene, Pediatric Dentistry
- Being tested
- Handled dental flossing system (GumChucks®), Interdental Brush
- Keywords
- Dental plaque, Gingivitis, Oral hygiene, Flossing, Interdental brushes, Interdental cleaning, Dental floss, Oral health, Preventive dentistry, Adolescents
- Medical subject headings
- Dental Plaque, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 BrushDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Interdental Brush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interdental plaque removal
Evaluated by measuring the modified Quigley-Hein plaque index scores (by Turesky et al., 1970) after using a plaque disclosing agent.
Measured: Baseline, 1 month, 3 months, and 6 months.
Gingival inflammation reduction
Evaluated by measuring the papillary bleeding index (PBI) scores (by Mühlemann, 1977).
Measured: Baseline, 1 month, 3 months, and 6 months.
Secondary outcomes (2)
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.
Measured: Dental Prophylaxis Session, 3 days before the Baseline examination session
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.
Measured: Dental Prophylaxis Session, 3 days before the Baseline examination session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start21 Nov 2022
- Primary completion10 Nov 2023
- Study completion10 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beirut Arab University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rim Daher, Beirut Arab University
- Investigators
- Rim K Daher, Masters, Principal investigator, Beirut Arab University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140068
- Sponsor's protocol ID
- 2023-H-0120-D-M-0527
- Status last verified
- Aug 2025
- First submitted
- 16 Aug 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing GumChucks Flossing System and Interdental Brushes in Plaque Removal Efficacy Among Lebanese Adolescents (A Randomized Controlled Trial).
- ClinicalTrials.gov ID
- NCT07140068
- Acronym / sponsor ID
- 2023-H-0120-D-M-0527
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Beirut Arab UniversityUniversity, hospital or other
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- 10 Nov 2023 (actual)
- Study completion
- 10 Nov 2023 (actual)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| GumChucks Flossing System | Experimental | Device: Handled dental flossing system (GumChucks®)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. |
| Interdental Brush | Experimental | Device: Interdental BrushParticipants 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. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Handled 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. | Device | GumChucks Flossing System |
| Interdental 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. | Device | Interdental Brush |
Primary outcome
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.
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).
2 secondary outcomes
Cleaning time
Time frame: Dental Prophylaxis Session, 3 days before the Baseline examination session
Participant and Parent Preferences.
Time frame: Dental Prophylaxis Session, 3 days before the Baseline examination session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rim K Daher, Masters principal investigator
Beirut Arab University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Handled dental flossing system (GumChucks®) and Interdental Brush in people with Healthy and Adolescent, run by Beirut Arab University at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interdental plaque removal (time frame: Baseline, 1 month, 3 months, and 6 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.