Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-29 @ 4:46 AM
Study NCT ID:
NCT07125560
Status:
COMPLETED
Last Update Posted:
2025-11-28
First Post:
2025-08-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness MyBRUSH Module in Improving Knowledge, Attitude, and Behaviour on Toothpaste Use and Toothbrushing Among 12-Year-Old Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003773', 'term': 'Dental Plaque'}], 'ancestors': [{'id': 'D003741', 'term': 'Dental Deposits'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 176}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-21', 'studyFirstSubmitDate': '2025-08-09', 'studyFirstSubmitQcDate': '2025-08-09', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knowledge, attitude, and behavior', 'timeFrame': 'Point measurement at baseline, evaluation-1, evaluation-2, and evaluation-3 with 1 month interval for each point measurement (total duration 4 months)', 'description': 'Assessment of knowledge, attitude, and behavior on toothpaste use and toothbrushing using a questionnaire'}, {'measure': 'Dental plaque score', 'timeFrame': 'Point measurement at baseline, evaluation-1, evaluation-2, and evaluation-3 with 1 month interval for each point measurement (total duration 4 months)', 'description': 'Dental plaque score based on Silness and Löe plaque index'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Toothpastes', 'Toothbrushing', 'Children', 'Intervention effectiveness'], 'conditions': ['Oral Health', 'Knowledge', 'Attitude', 'Behavior', 'Dental Plaque']}, 'descriptionModule': {'briefSummary': 'The goal of this intervention study is to study the effectiveness of the oral health education module (MyBRUSH) in improving the knowledge, attitude, and behaviour on toothpaste use and toothbrushing among 12-year-old children. This study also aims to study the effectiveness of the MyBRUSH module in improving dental plaque among 12-year-old children. The main questions it aims to answer are:\n\n1. Does the knowledge, attitude, and behaviour on toothpaste use and toothbrushing of 12-year-old children improve after receiving the MyBRUSH module?\n2. Does the dental plaque score of 12-year-old children improve after receiving the MyBRUSH module?\n3. Does the improvement in knowledge, attitude, and behaviour regarding toothpaste use and toothbrushing, as well as the dental plaque of 12-year-old children, be higher after receiving the MyBRUSH module compared to those who received the existing toothbrushing module?\n\nResearchers will compare the MyBRUSH module to a BEGIN (existing toothbrushing module) to see if the MyBRUSH module is effective in improving the knowledge, attitude, and behaviour on toothpaste use and toothbrushing, as well as the dental plaque of 12-year-old children.\n\nParticipants will:\n\n* A questionnaire will be used to assess knowledge, attitude, and behaviour regarding toothpaste use and toothbrushing. This assessment will be done at four time points (baseline, evaluation-1, evaluation-2, and evaluation-3), with a one-month interval between each time point.\n* A group of participants will receive intervention based on MyBRUSH module and another group of participants will receive intervention based on BEGIN. Each intervention activity will be done after each evaluation assessment is completed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Malaysian citizen\n* Children born in 2013, who would be 12-year-old in 2025\n* Children using toothpaste during toothbrushing\n\nExclusion Criteria:\n\n\\- Children with special educational needs based on the Ministry of Education (MOE) Malaysia definition'}, 'identificationModule': {'nctId': 'NCT07125560', 'acronym': 'MyBRUSH module', 'briefTitle': 'Effectiveness MyBRUSH Module in Improving Knowledge, Attitude, and Behaviour on Toothpaste Use and Toothbrushing Among 12-Year-Old Children', 'organization': {'class': 'OTHER', 'fullName': 'Universiti Sains Malaysia'}, 'officialTitle': 'The Effectiveness of Oral Health Education Module (MyBRUSH) in Improving Knowledge, Attitude, and Behaviour on Toothpaste Use and Toothbrushing Among 12-Year-Old Children in Tawau Division, Sabah: A Cluster Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'USM/JEPeM/KK/24040379'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'interventionNames': ['Behavioral: MyBRUSH module']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'interventionNames': ['Behavioral: BEGIN program']}], 'interventions': [{'name': 'MyBRUSH module', 'type': 'BEHAVIORAL', 'description': 'oral health education module that comprises of booklet for educational material, oral health talk, toothbrushing demonstration and return demonstration, and small group discussion', 'armGroupLabels': ['Intervention group']}, {'name': 'BEGIN program', 'type': 'BEHAVIORAL', 'description': 'BEGIN program that comprise of toothbrushing demonstration and return demonstration', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91207', 'city': 'Kunak', 'state': 'Sabah', 'country': 'Malaysia', 'facility': 'SJKC Pai Sheng', 'geoPoint': {'lat': 4.68577, 'lon': 118.24908}}, {'zip': '91207', 'city': 'Kunak', 'state': 'Sabah', 'country': 'Malaysia', 'facility': 'SK Kampung Selamat', 'geoPoint': {'lat': 4.68577, 'lon': 118.24908}}, {'zip': '91207', 'city': 'Kunak', 'state': 'Sabah', 'country': 'Malaysia', 'facility': 'SK Mostyn', 'geoPoint': {'lat': 4.68577, 'lon': 118.24908}}, {'zip': '91207', 'city': 'Kunak', 'state': 'Sabah', 'country': 'Malaysia', 'facility': 'SK SKIM Kokos', 'geoPoint': {'lat': 4.68577, 'lon': 118.24908}}, {'zip': '91000', 'city': 'Tawau', 'state': 'Sabah', 'country': 'Malaysia', 'facility': 'SK Balung', 'geoPoint': {'lat': 4.24482, 'lon': 117.89115}}, {'zip': '91000', 'city': 'Tawau', 'state': 'Sabah', 'country': 'Malaysia', 'facility': 'SK Bombalai', 'geoPoint': {'lat': 4.24482, 'lon': 117.89115}}, {'zip': '91000', 'city': 'Tawau', 'state': 'Sabah', 'country': 'Malaysia', 'facility': 'SK Holy Trinity', 'geoPoint': {'lat': 4.24482, 'lon': 117.89115}}, {'zip': '91000', 'city': 'Tawau', 'state': 'Sabah', 'country': 'Malaysia', 'facility': 'SK Jambatan Putih', 'geoPoint': {'lat': 4.24482, 'lon': 117.89115}}], 'overallOfficials': [{'name': 'Mohd Ritzuan Abdul Multalib', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universiti Sains Malaysia'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'ipdSharing': 'YES', 'description': 'all IPD that underlie results in a publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiti Sains Malaysia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dental Officer', 'investigatorFullName': 'Mohd Ritzuan Abdul Multalib', 'investigatorAffiliation': 'Universiti Sains Malaysia'}}}}