Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-31 @ 9:16 PM
Study NCT ID:
NCT07115433
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-11
First Post:
2025-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of School-based Oral Health Intervention for Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Investigators and outcome assessors will be blinded'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'It is two arm randomized control trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-02-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-03', 'studyFirstSubmitDate': '2025-08-03', 'studyFirstSubmitQcDate': '2025-08-03', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plaque score', 'timeFrame': '6 months', 'description': 'Plaque score index: 0: No plaque.\n\n1. Separate flecks of plaque at the gum line.\n2. A thin band of plaque along the gum line.\n3. A band of plaque wider than 1mm but covering less than one-third of the tooth.\n4. Plaque covering one-third to two-thirds of the tooth.\n5. Plaque covering more than two-thirds of the tooth. Higher scores indicate more plaque and poorer oral hygiene.'}, {'measure': 'Oral Hygiene', 'timeFrame': '6-months', 'description': 'Oral Hygiene will be assessed by the presence of debris (plaque) and calculus (tartar) on selected tooth surfaces, measured by the Simplified Oral Hygiene Index (OHI-S)\n\nIndividual Debris Index (DI-S) and Calculus Index (CI-S):\n\nEach of the six surfaces is scored individually for both debris and calculus using a 0-3 scale:\n\n0: No debris or calculus is present.\n\n1. Debris or calculus covers less than one-third of the surface.\n2. Debris or calculus covers between one-third and two-thirds of the surface.\n3. Debris or calculus covers more than two-thirds of the surface. Good: 0.0 - 1.2 Fair: 1.3 - 3.0 Poor: 3.1 - 6.0'}, {'measure': 'Gingival score', 'timeFrame': '6 months', 'description': 'Gingival score assessed by the gingival score index:\n\n0: Normal gingiva, no inflammation.\n\n1. Mild inflammation - slight color change and edema (swelling), no bleeding on probing.\n2. Moderate inflammation - redness, edema, glazing, and bleeding on probing.\n3. Severe inflammation - marked redness, edema, ulceration, and tendency towards spontaneous bleeding. The index typically uses a scale of 0 to 3, with 0 representing normal gingiva and higher scores indicating increasing severity of inflammation'}], 'secondaryOutcomes': [{'measure': 'oral health practices', 'timeFrame': '6 months', 'description': "Oral health practices by using the WHO Child Oral Health Questionnaire: o assess children's oral health practices through a structured set of questions. These questionnaires typically cover knowledge, attitude, and practices related to oral hygiene, including frequency of brushing, use of fluoride toothpaste, and dental visits. The score is used to evaluate the overall oral health practices of the child, often categorized as good, fair, or poor."}, {'measure': 'Oral Health Impact Profile.', 'timeFrame': '6 months', 'description': "Oral Health Impact Profile. The Oral Health Impact Profile (OHIP) is a questionnaire used to assess how oral health problems affect a person's daily life and well-being. The OHIP-14, a shorter version, is commonly used and focuses on 14 specific questions related to oral health impacts 0 = Never\n\n1. = Hardly ever\n2. = Occasionally\n3. = Fairly often\n4. = Very often Greater score shows better impact andvice versa"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oral', 'Health']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'nsari Moghaddam S, Shahrzad S, Kermansaravi F. Effect of teach-back method on oral health indicators, self-efficacy, and self-care behaviors of high school students in Zahedan during 2019. J Mashhad Dent School. 2020;44(2):99-113.'}, {'pmid': '34256752', 'type': 'BACKGROUND', 'citation': 'Hashemi ZS, Khorsandi M, Shamsi M, Moradzadeh R. Effect combined learning on oral health self-efficacy and self-care behaviors of students: a randomized controlled trial. BMC Oral Health. 2021 Jul 13;21(1):342. doi: 10.1186/s12903-021-01693-y.'}, {'pmid': '35346148', 'type': 'BACKGROUND', 'citation': 'Sanaeinasab H, Saffari M, Taghavi H, Karimi Zarchi A, Rahmati F, Al Zaben F, Koenig HG. An educational intervention using the health belief model for improvement of oral health behavior in grade-schoolers: a randomized controlled trial. BMC Oral Health. 2022 Mar 27;22(1):94. doi: 10.1186/s12903-022-02132-2.'}, {'pmid': '34698662', 'type': 'BACKGROUND', 'citation': 'Hernandez-Vasquez A, Azanedo D. The urgency of ensuring equitable and improved access to oral health care during the Coronavirus Disease 2019 pandemic: The case of Peru. J Res Health Sci. 2021 Aug 28;21(3):e00528. doi: 10.34172/jrhs.2021.60.'}]}, 'descriptionModule': {'briefSummary': 'Schools provide an ideal setting for early interventions. Evidence suggests that educational programs incorporating behavioural change theories can improve oral hygiene practices and clinical outcomes.\n\nA School-Based Oral Health Promotion Program on Oral Health Practices, Behaviour, Self-Efficacy, and Clinical Outcomes Among Primary School Children for six months, while the control group will receive no intervention, only routine care.', 'detailedDescription': 'Poor oral health in children leads to pain, absenteeism, and impaired quality of life. Schools provide an ideal setting for early interventions. Evidence suggests that educational programs incorporating behavioural change theories can improve oral hygiene practices and clinical outcomes.\n\nA School-Based Oral Health Promotion Program on Oral Health Practices, Behaviour, Self-Efficacy, and Clinical Outcomes Among Primary School. The oral health promotion intervention will be implemented through weekly interactive sessions lasting 30-40 minutes over six months. These sessions, conducted by trained dental educators and teachers, will use animations, storytelling, demonstrations, and role-plays to teach proper toothbrushing, the importance of fluoride toothpaste, healthy eating habits, and the need for regular dental visits. Children will participate in supervised toothbrushing once a week, supported by peer ambassadors who reinforce daily practices. Educational leaflets and videos will engage parents, while posters in classrooms serve as reminders. Follow-up assessments, including questionnaires and clinical indices, will be conducted at six months, while the control group will receive no intervention, only routine care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 6-8 years enrolled in selected schools\n* Written informed consent from parents/guardians and assent from children\n\nExclusion Criteria:\n\n* Children with systemic conditions affecting oral health\n* Those currently in other oral health interventions'}, 'identificationModule': {'nctId': 'NCT07115433', 'briefTitle': 'Effectiveness of School-based Oral Health Intervention for Children', 'organization': {'class': 'OTHER', 'fullName': 'Universiti Putra Malaysia'}, 'officialTitle': 'Effectiveness of a School-Based Oral Health Promotion Program on Oral Health Practices, Behaviour, Self-Efficacy, and Clinical Outcomes Among Primary School Children: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'BMU-BDC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The control group will be given no intervention other than they will receive routinely'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Arm Description: The oral health promotion intervention will be implemented through weekly interactive sessions lasting 30-40 minutes over a period of six months. These sessions, conducted by trained dental educators and teachers, will use animations, storytelling, demonstrations, and role-plays to teach proper toothbrushing, the importance of fluoride toothpaste, healthy eating habits, and the need for regular dental visits. Children will participate in supervised toothbrushing once a week, supported by peer ambassadors who reinforce daily practices. Educational leaflets and videos will engage parents, while posters in classrooms serve as reminders. Follow-up assessments, including questionnaires and clinical indices, will be conducted at six months.', 'interventionNames': ['Behavioral: School-Based Oral Health Promotion Program']}], 'interventions': [{'name': 'School-Based Oral Health Promotion Program', 'type': 'BEHAVIORAL', 'description': 'Arm Description: The oral health promotion intervention will be implemented through weekly interactive sessions lasting 30-40 minutes over a period of six months. These sessions, conducted by trained dental educators and teachers, will use animations, storytelling, demonstrations, and role-plays to teach proper toothbrushing, the importance of fluoride toothpaste, healthy eating habits, and the need for regular dental visits. Children will participate in supervised toothbrushing once a week, supported by peer ambassadors who reinforce daily practices. Educational leaflets and videos will engage parents, while posters in classrooms serve as reminders. Follow-up assessments, including questionnaires and clinical indices, will be conducted at six months.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74600', 'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'contacts': [{'name': 'Samreen Z Instructor, BDS', 'role': 'CONTACT', 'email': 'kiranmehwish47@gmail.com', 'phone': '03150228348'}, {'name': 'Muhammad Raashed, DVM', 'role': 'CONTACT', 'email': 'muhammad.raashed.eph@gmail.com', 'phone': '03337474991'}], 'facility': 'Saleem ullah fahmi school baqai Medical complex gharo', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}, {'zip': '74600', 'city': 'Karachi', 'country': 'Pakistan', 'contacts': [{'name': 'Mehwish banu, BDS', 'role': 'CONTACT', 'email': 'drmahwishsyed@baqai.edu.pk', 'phone': '03323404875'}, {'name': 'Muhammad Arshed, MBBS, PhD', 'role': 'CONTACT', 'email': 'drarshedchaudhary@gmail.com', 'phone': '03337474464'}], 'facility': 'Saleem ullah fahmi memorial school unit 1', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}, {'zip': '74600', 'city': 'Karachi', 'country': 'Pakistan', 'contacts': [{'name': 'Samreen Instructor, BDS', 'role': 'CONTACT', 'email': 'drsamreen.shafqat@gmail.com', 'phone': '+92 332 2536389'}, {'name': 'Muhammad Arshed, MBBS, PhD', 'role': 'CONTACT', 'email': 'drarshedchaudhary@gmail.com', 'phone': '03337474464'}], 'facility': 'Saleem ullah fahmi school Khuda ki basti', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'centralContacts': [{'name': 'Dr. Mehwish Raheem, MBBS, MPH', 'role': 'CONTACT', 'email': 'kiranmehwish47@gmail.com', 'phone': '00923249479263'}, {'name': 'Muhammad Arshed, MBBS, MPH,PhD', 'role': 'CONTACT', 'email': 'drarshedchaudhary@gmail.com', 'phone': '00923137774464'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Only the study protocol, statistical plan, and results will be shared in publications in peer-reviewed journals'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiti Putra Malaysia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Arshed Muhammad', 'investigatorAffiliation': 'Universiti Putra Malaysia'}}}}