Ignite Creation Date:
2025-12-24 @ 12:07 PM
Ignite Modification Date:
2025-12-27 @ 9:08 PM
Study NCT ID:
NCT07139561
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-24
First Post:
2025-08-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Digital Intervention to Improve Oral Health Practices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009909', 'term': 'Oral Health'}], 'ancestors': [{'id': 'D006262', 'term': 'Health'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', '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': 800}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-18', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-02-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-17', 'studyFirstSubmitDate': '2025-08-17', 'studyFirstSubmitQcDate': '2025-08-17', 'lastUpdatePostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oral health practices', 'timeFrame': '4-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 Hygiene', 'timeFrame': '4-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) Individual Debris Index (DI-S) and Calculus Index (CI-S): Each of the six surfaces is scored individually for both debris and calculus using a 0-3 scale: 0: No debris or calculus is present. 1: Debris or calculus covers less than one-third of the surface. 2: Debris or calculus covers between one-third and two-thirds of the surface. 3: 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'}], 'secondaryOutcomes': [{'measure': 'Plaque score', 'timeFrame': '4-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) Individual Debris Index (DI-S) and Calculus Index (CI-S): Each of the six surfaces is scored individually for both debris and calculus using a 0-3 scale: 0: No debris or calculus is present. 1: Debris or calculus covers less than one-third of the surface. 2: Debris or calculus covers between one-third and two-thirds of the surface. 3: 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': '4-months', 'description': 'Gingival score assessed by the gingival score index: 0: Normal gingiva, no inflammation. 1: Mild inflammation - slight color change and edema (swelling), no bleeding on probing. 2: Moderate inflammation - redness, edema, glazing, and bleeding on probing. 3: 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'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Digital Intervention', 'Oral Health Behavior Change']}, 'referencesModule': {'references': [{'pmid': '26631059', 'type': 'BACKGROUND', 'citation': 'Li X, Xu ZR, Tang N, Ye C, Zhu XL, Zhou T, Zhao ZH. Effect of intervention using a messaging app on compliance and duration of treatment in orthodontic patients. Clin Oral Investig. 2016 Nov;20(8):1849-1859. doi: 10.1007/s00784-015-1662-6. Epub 2015 Dec 2.'}, {'pmid': '29458358', 'type': 'BACKGROUND', 'citation': 'Lee JA, Choi M, Lee SA, Jiang N. Effective behavioral intervention strategies using mobile health applications for chronic disease management: a systematic review. BMC Med Inform Decis Mak. 2018 Feb 20;18(1):12. doi: 10.1186/s12911-018-0591-0.'}, {'pmid': '32291154', 'type': 'BACKGROUND', 'citation': 'Machado RA, de Souza NL, Oliveira RM, Martelli Junior H, Bonan PRF. Social media and telemedicine for oral diagnosis and counselling in the COVID-19 era. Oral Oncol. 2020 Jun;105:104685. doi: 10.1016/j.oraloncology.2020.104685. Epub 2020 Apr 10. No abstract available.'}, {'type': 'BACKGROUND', 'citation': "Abduljalil HS, Abuaffan AH. 'Knowledge and practice of mothers in relation to dental health of pre-school children. Adv Genet Eng. 2016;5:1-7. https://doi.org/10.4172/2169-0111.1000153."}, {'pmid': '30430070', 'type': 'BACKGROUND', 'citation': 'Alqarni AA, Alfaifi HM, Aseeri NA, Gadah T, Togoo RA. Efficacy of a Self-Designed Mobile Application to Improve Child Dental Health Knowledge among Parents. J Int Soc Prev Community Dent. 2018 Sep-Oct;8(5):424-430. doi: 10.4103/jispcd.JISPCD_195_18. Epub 2018 Oct 8.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates a 16-week parent-focused digital intervention to improve oral health practices in children aged 6-10 through daily reminders, quizzes, challenges, gamification, and behavior tracking, supported by an optional moderated WhatsApp group for peer engagement and motivation.', 'detailedDescription': 'The intervention includes daily reminders with two brushing cues and one snack tip to reinforce habits. Weekly quizzes with 3-5 questions assess knowledge, while photo/video tasks such as "Show your foam smile" or "Healthy lunchbox challenge" keep engagement high. Gamification features badges for streaks like a 7-day brushing badge or snack swap champion. Parents track brushing, flossing, and snack swaps via a 1-tap tracker, supported by an optional moderated WhatsApp group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parents or primary caregivers of children aged 6-10 years.\n* Child must be free from major systemic illnesses or developmental disabilities that could interfere with oral hygiene practices.\n* Parent/caregiver owns a smartphone with access to WhatsApp or similar digital platform.\n* Ability to read or understand Urdu or English instructions.\n* Willingness to participate for the full 12-week duration and provide informed consent.\n\nExclusion Criteria:\n\n* Children with serious medical conditions (e.g., immunodeficiency, congenital anomalies) that may affect oral health.\n* Parents or children currently enrolled in another oral health education or digital intervention program.\n* Children who have received professional oral health education or structured interventions within the past 4 months.\n* Parents/caregivers unwilling or unable to comply with digital reporting and participation requirements.'}, 'identificationModule': {'nctId': 'NCT07139561', 'briefTitle': 'A Digital Intervention to Improve Oral Health Practices', 'organization': {'class': 'OTHER', 'fullName': 'Universiti Putra Malaysia'}, 'officialTitle': 'Oral Health in Hands: A Digital Intervention to Improve Oral Health Practices in Children', 'orgStudyIdInfo': {'id': 'BMU-BBC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The control group will be given no intervention other than they will receive routinely'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention arm', 'description': 'Oral Health in Hands - Parent Digital Program: The intervention includes daily reminders with two brushing cues and one snack tip to reinforce habits. Weekly quizzes with 3-5 questions assess knowledge, while photo/video tasks such as "Show your foam smile" or "Healthy lunchbox challenge" keep engagement high. Gamification features badges for streaks like a 7-day brushing badge or snack swap champion. Parents track brushing, flossing, and snack swaps via a 1-tap tracker, supported by an optional moderated WhatsApp group.', 'interventionNames': ['Behavioral: Oral Health in Hands - Parent Digital Program']}], 'interventions': [{'name': 'Oral Health in Hands - Parent Digital Program', 'type': 'BEHAVIORAL', 'description': 'The 16-week parent-focused digital intervention aims to improve oral health practices in children aged 6-10 by empowering parents through structured, engaging, and cost-effective activities. Parents receive daily reminders, including two brushing cues and one snack tip, to reinforce healthy routines. Weekly quizzes with 3-5 questions enhance knowledge retention, while interactive photo or video tasks such as "Show your foam smile" or "Healthy lunchbox challenge" promote family involvement and fun. Gamification strategies include awarding digital badges for streaks, such as the 7-day brushing badge and snack swap champion, to maintain motivation. Parents track brushing, flossing, and snack swaps using a simple 1-tap tracker, ensuring easy and consistent reporting. An optional moderated WhatsApp group provides a platform for sharing tips, photos, and encouragement, fostering a supportive peer community. The intervention combines education, habit formation, and social support to sustainab', 'armGroupLabels': ['Intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54590', 'city': 'Chak Seventeen', 'state': 'Punjab Province', 'country': 'Pakistan', 'contacts': [{'name': 'shahzain shahzain, MBBS', 'role': 'CONTACT', 'email': 'shahzainmomn009@mail.com', 'phone': '03337474464'}], 'facility': 'White house grammar School', 'geoPoint': {'lat': 32.45385, 'lon': 73.32557}}, {'zip': '74600', 'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'contacts': [{'name': 'Mehwish Raheem, MPH', 'role': 'CONTACT', 'email': 'kiranmehwish47@gmail.com', 'phone': 'O3137774464'}], 'facility': 'Baqai Medical complex school', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}, {'zip': '74600', 'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'contacts': [{'name': 'Muhammad Rashed, MPhil', 'role': 'CONTACT', 'email': 'stunning003@gmail.com', 'phone': '00923337474991'}], 'facility': 'Saleem ullah fahmi memorial school unit 1', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}, {'zip': '74600', 'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'contacts': [{'name': 'Samreen, BDS', 'role': 'CONTACT', 'email': 'muhammad.raashed.eph@gmail.com', 'phone': '03150228348'}], 'facility': 'Saleem ullah fahmi school baqai Medical complex gharo, Karachi', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'centralContacts': [{'name': 'MUHAMMAD ARSHED, PhD', 'role': 'CONTACT', 'email': 'drarshedchaudhary@gmail.com', 'phone': '+923337474464'}]}, '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'}}}}