Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-29 @ 5:55 PM
Study NCT ID:
NCT07140068
Status:
COMPLETED
Last Update Posted:
2025-08-24
First Post:
2025-08-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GumChucks vs Interdental Brushes in Plaque Removal.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003773', 'term': 'Dental Plaque'}, {'id': 'D005891', 'term': 'Gingivitis'}], 'ancestors': [{'id': 'D003741', 'term': 'Dental Deposits'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': "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."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "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."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2023-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-22', 'studyFirstSubmitDate': '2025-08-16', 'studyFirstSubmitQcDate': '2025-08-22', 'lastUpdatePostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Interdental plaque removal', 'timeFrame': 'Baseline, 1 month, 3 months, and 6 months.', 'description': 'Evaluated by measuring the modified Quigley-Hein plaque index scores (by Turesky et al., 1970) after using a plaque disclosing agent.'}, {'measure': 'Gingival inflammation reduction', 'timeFrame': 'Baseline, 1 month, 3 months, and 6 months.', 'description': 'Evaluated by measuring the papillary bleeding index (PBI) scores (by Mühlemann, 1977).'}], 'secondaryOutcomes': [{'measure': 'Cleaning time', 'timeFrame': 'Dental Prophylaxis Session, 3 days before the Baseline examination session', 'description': "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."}, {'measure': 'Participant and Parent Preferences.', 'timeFrame': 'Dental Prophylaxis Session, 3 days before the Baseline examination session', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dental plaque', 'Gingivitis', 'Oral hygiene', 'Flossing', 'Interdental brushes', 'Interdental cleaning', 'Dental floss', 'Oral health', 'Preventive dentistry', 'Adolescents'], 'conditions': ['Healthy', 'Adolescent', 'Dental Plaque', 'Gingivitis', 'Oral Hygiene', 'Pediatric Dentistry']}, 'descriptionModule': {'briefSummary': '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.\n\nPlaque 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.\n\nIn 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.\n\nResearchers 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.', 'detailedDescription': "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.\n\nParticipants 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.\n\nDuring 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.\n\nClinical 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.\n\nIntra- and inter-examiner reliability were evaluated using Cohen's Kappa statistics."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adolescents (ASA 1) aged between 10 and 15 years;\n* Patients who had at least 4 posterior interdental contacts;\n* 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.\n\nExclusion Criteria:\n\n* Patients who had antibiotics within the last 6 months;\n* Patients who were using antibacterial mouth rinses;\n* Patients with physical, intellectual, developmental, or emotional disabilities;\n* Patients with unilateral mastication or a nonfunctional side.'}, 'identificationModule': {'nctId': 'NCT07140068', 'briefTitle': 'GumChucks vs Interdental Brushes in Plaque Removal.', 'organization': {'class': 'OTHER', 'fullName': 'Beirut Arab University'}, 'officialTitle': 'Comparing GumChucks Flossing System and Interdental Brushes in Plaque Removal Efficacy Among Lebanese Adolescents (A Randomized Controlled Trial).', 'orgStudyIdInfo': {'id': '2023-H-0120-D-M-0527'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GumChucks Flossing System', 'description': '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.', 'interventionNames': ['Device: Handled dental flossing system (GumChucks®)']}, {'type': 'EXPERIMENTAL', 'label': 'Interdental Brush', 'description': '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.', 'interventionNames': ['Device: Interdental Brush']}], 'interventions': [{'name': 'Handled dental flossing system (GumChucks®)', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['GumChucks Flossing System']}, {'name': 'Interdental Brush', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Interdental Brush']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11-50-20', 'city': 'Beirut', 'state': 'Tarik El Jadida', 'country': 'Lebanon', 'facility': 'Beirut Arab University', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}], 'overallOfficials': [{'name': 'Rim K Daher, Masters', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beirut Arab University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beirut Arab University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Pediatric Dentistry Resident', 'investigatorFullName': 'Rim Daher', 'investigatorAffiliation': 'Beirut Arab University'}}}}