Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-03-09 @ 2:27 AM
Study NCT ID:
NCT02937194
Status:
COMPLETED
Last Update Posted:
2021-04-22
First Post:
2016-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Family-centered Oral Health Promotion for New Parents
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mcmwong@hku.hk', 'phone': '852-28590422', 'title': 'Prof Wong, May Chun Mei', 'organization': 'The University of Hong Kong'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year, 2 years and 3 years followup', 'eventGroups': [{'id': 'EG000', 'title': 'Personal Oral Health Instruction + Pamphlets Distribution', 'description': "Personal oral health instruction (OHI) for the expectant mothers and their husbands together with oral health education materials on infant's tooth development and eruption, establishment of proper feeding, dietary and toothbrushing habits will be given before baby delivery. Reinforcement of OHI and demonstrations on how to clean the infant's oral cavities and perform toothbrushing will be delivered after the babies are born.\n\nPersonal oral health instruction + pamphlets distribution: Personal oral health instruction (OHI) and oral health pamphlets distribution", 'otherNumAtRisk': 294, 'deathsNumAtRisk': 294, 'otherNumAffected': 0, 'seriousNumAtRisk': 294, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Pamphlets Distribution', 'description': "Pamphlets for adults' and pregnant women's oral health care will be distributed when recruited and information on the babies' oral health care will be distributed before baby delivery.\n\nPamphlets distribution: Oral health pamphlets distribution", 'otherNumAtRisk': 286, 'deathsNumAtRisk': 286, 'otherNumAffected': 0, 'seriousNumAtRisk': 286, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Early Childhood Caries (ECC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Personal Oral Health Instruction + Pamphlets Distribution', 'description': "Personal oral health instruction (OHI) for the expectant mothers and their husbands together with oral health education materials on infant's tooth development and eruption, establishment of proper feeding, dietary and toothbrushing habits will be given before baby delivery. Reinforcement of OHI and demonstrations on how to clean the infant's oral cavities and perform toothbrushing will be delivered after the babies are born.\n\nPersonal oral health instruction + pamphlets distribution: Personal oral health instruction (OHI) and oral health pamphlets distribution"}, {'id': 'OG001', 'title': 'Pamphlets Distribution', 'description': "Pamphlets for adults' and pregnant women's oral health care will be distributed when recruited and information on the babies' oral health care will be distributed before baby delivery.\n\nPamphlets distribution: Oral health pamphlets distribution"}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 months', 'description': 'Prevalence of early childhood caries (ECC) among study children at 36 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Parental Toothbrushing on Infants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Personal Oral Health Instruction + Pamphlets Distribution', 'description': "Personal oral health instruction (OHI) for the expectant mothers and their husbands together with oral health education materials on infant's tooth development and eruption, establishment of proper feeding, dietary and toothbrushing habits will be given before baby delivery. Reinforcement of OHI and demonstrations on how to clean the infant's oral cavities and perform toothbrushing will be delivered after the babies are born.\n\nPersonal oral health instruction + pamphlets distribution: Personal oral health instruction (OHI) and oral health pamphlets distribution"}, {'id': 'OG001', 'title': 'Pamphlets Distribution', 'description': "Pamphlets for adults' and pregnant women's oral health care will be distributed when recruited and information on the babies' oral health care will be distributed before baby delivery.\n\nPamphlets distribution: Oral health pamphlets distribution"}], 'classes': [{'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': "Proportion of parents who brushed their infants' teeth regularly twice daily at 12 months", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Feeding Habits on Infants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Personal Oral Health Instruction + Pamphlets Distribution', 'description': "Personal oral health instruction (OHI) for the expectant mothers and their husbands together with oral health education materials on infant's tooth development and eruption, establishment of proper feeding, dietary and toothbrushing habits will be given before baby delivery. Reinforcement of OHI and demonstrations on how to clean the infant's oral cavities and perform toothbrushing will be delivered after the babies are born.\n\nPersonal oral health instruction + pamphlets distribution: Personal oral health instruction (OHI) and oral health pamphlets distribution"}, {'id': 'OG001', 'title': 'Pamphlets Distribution', 'description': "Pamphlets for adults' and pregnant women's oral health care will be distributed when recruited and information on the babies' oral health care will be distributed before baby delivery.\n\nPamphlets distribution: Oral health pamphlets distribution"}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Proportion of infants falling asleep during milk-feeding', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The numbers of participants analyzed here are those who finished basiline and one-year follow-up examination.'}, {'type': 'SECONDARY', 'title': 'Ratio of Mutans Streptococci (MS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Personal Oral Health Instruction + Pamphlets Distribution', 'description': "Personal oral health instruction (OHI) for the expectant mothers and their husbands together with oral health education materials on infant's tooth development and eruption, establishment of proper feeding, dietary and toothbrushing habits will be given before baby delivery. Reinforcement of OHI and demonstrations on how to clean the infant's oral cavities and perform toothbrushing will be delivered after the babies are born.\n\nPersonal oral health instruction + pamphlets distribution: Personal oral health instruction (OHI) and oral health pamphlets distribution"}, {'id': 'OG001', 'title': 'Pamphlets Distribution', 'description': "Pamphlets for adults' and pregnant women's oral health care will be distributed when recruited and information on the babies' oral health care will be distributed before baby delivery.\n\nPamphlets distribution: Oral health pamphlets distribution"}], 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'spread': '15.7', 'groupId': 'OG000'}, {'value': '11.6', 'spread': '17.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': 'Proportion of MS with respect to the total bacterial count', 'unitOfMeasure': 'Ratio of MS in the total bacterial count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Mothers' Gingival Bleeding", 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Personal Oral Health Instruction + Pamphlets Distribution', 'description': "Personal oral health instruction (OHI) for the expectant mothers and their husbands together with oral health education materials on infant's tooth development and eruption, establishment of proper feeding, dietary and toothbrushing habits will be given before baby delivery. Reinforcement of OHI and demonstrations on how to clean the infant's oral cavities and perform toothbrushing will be delivered after the babies are born.\n\nPersonal oral health instruction + pamphlets distribution: Personal oral health instruction (OHI) and oral health pamphlets distribution"}, {'id': 'OG001', 'title': 'Pamphlets Distribution', 'description': "Pamphlets for adults' and pregnant women's oral health care will be distributed when recruited and information on the babies' oral health care will be distributed before baby delivery.\n\nPamphlets distribution: Oral health pamphlets distribution"}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'spread': '29', 'groupId': 'OG000'}, {'value': '46', 'spread': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Percentage of probing sites with gingival bleeding (BOP%, range 0-100%)', 'unitOfMeasure': 'Percentage of sites with bleeding', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The numbers of participants analyzed here are those who finished basiline and one-year follow-up gingival bleeding examination.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Personal Oral Health Instruction + Pamphlets Distribution', 'description': "Personal oral health instruction (OHI) for the expectant mothers and their husbands together with oral health education materials on infant's tooth development and eruption, establishment of proper feeding, dietary and toothbrushing habits will be given before baby delivery. Reinforcement of OHI and demonstrations on how to clean the infant's oral cavities and perform toothbrushing will be delivered after the babies are born.\n\nPersonal oral health instruction + pamphlets distribution: Personal oral health instruction (OHI) and oral health pamphlets distribution"}, {'id': 'FG001', 'title': 'Pamphlets Distribution', 'description': "Pamphlets for adults' and pregnant women's oral health care will be distributed when recruited and information on the babies' oral health care will be distributed before baby delivery.\n\nPamphlets distribution: Oral health pamphlets distribution"}], 'periods': [{'title': '1-year Followup', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '294'}, {'groupId': 'FG001', 'numSubjects': '286'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '223'}, {'groupId': 'FG001', 'numSubjects': '218'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '68'}]}]}, {'title': '2-years Followup', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'The researchers contacted all the participants recruited/enrolled at baseline at each follow-up regardless if they had participated in the previous follow-up or not. So the number started equals 294 for each follow-up.', 'groupId': 'FG000', 'numSubjects': '294'}, {'comment': 'The researchers contacted all the participants recruited/enrolled at baseline at each follow-up regardless if they had participated in the previous follow-up or not. So the number started equals 286 for each follow-up.', 'groupId': 'FG001', 'numSubjects': '286'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '216'}, {'groupId': 'FG001', 'numSubjects': '208'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '78'}]}]}, {'title': '3-years Followup', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'The researchers contacted all the participants recruited/enrolled at baseline at each follow-up regardless if they had participated in the previous follow-up or not. So the number started equals 294 for each follow-up.', 'groupId': 'FG000', 'numSubjects': '294'}, {'comment': 'The researchers contacted all the participants recruited/enrolled at baseline at each follow-up regardless if they had participated in the previous follow-up or not. So the number started equals 286 for each follow-up.', 'groupId': 'FG001', 'numSubjects': '286'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '228'}, {'groupId': 'FG001', 'numSubjects': '208'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '78'}]}]}], 'recruitmentDetails': 'The pregnant women and their husbands were recruited from the Obstetrics \\& Gynaecology Department of three public hospitals and from two Maternal and Child Health Centers in Hong Kong. The potential participants were approached during their prenatal visits with minimal disturbance to the routine care at the recruitment sites. Written informed consent was obtained from both the pregnant woman and the husband. The recruitment period was from June 2014 to June 2016.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'BG000'}, {'value': '286', 'groupId': 'BG001'}, {'value': '580', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Personal Oral Health Instruction + Pamphlets Distribution', 'description': "Personal oral health instruction (OHI) for the expectant mothers and their husbands together with oral health education materials on infant's tooth development and eruption, establishment of proper feeding, dietary and toothbrushing habits will be given before baby delivery. Reinforcement of OHI and demonstrations on how to clean the infant's oral cavities and perform toothbrushing will be delivered after the babies are born.\n\nPersonal oral health instruction + pamphlets distribution: Personal oral health instruction (OHI) and oral health pamphlets distribution"}, {'id': 'BG001', 'title': 'Pamphlets Distribution', 'description': "Pamphlets for adults' and pregnant women's oral health care will be distributed when recruited and information on the babies' oral health care will be distributed before baby delivery.\n\nPamphlets distribution: Oral health pamphlets distribution"}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.7', 'spread': '3.7', 'groupId': 'BG000'}, {'value': '31.6', 'spread': '4.2', 'groupId': 'BG001'}, {'value': '31.7', 'spread': '4.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Mother's age", 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.9', 'spread': '5.1', 'groupId': 'BG000'}, {'value': '33.4', 'spread': '5.2', 'groupId': 'BG001'}, {'value': '33.6', 'spread': '5.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Father's age", 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Mother', 'categories': [{'measurements': [{'value': '294', 'groupId': 'BG000'}, {'value': '286', 'groupId': 'BG001'}, {'value': '580', 'groupId': 'BG002'}]}]}, {'title': 'Father', 'categories': [{'measurements': [{'value': '294', 'groupId': 'BG000'}, {'value': '286', 'groupId': 'BG001'}, {'value': '580', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Families'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Chinese', 'categories': [{'measurements': [{'value': '294', 'groupId': 'BG000'}, {'value': '286', 'groupId': 'BG001'}, {'value': '580', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Families'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-25', 'size': 439983, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-01-08T00:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 580}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-26', 'studyFirstSubmitDate': '2016-10-05', 'resultsFirstSubmitDate': '2021-01-08', 'studyFirstSubmitQcDate': '2016-10-16', 'lastUpdatePostDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-26', 'studyFirstPostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early Childhood Caries (ECC)', 'timeFrame': '36 months', 'description': 'Prevalence of early childhood caries (ECC) among study children at 36 months'}, {'measure': 'Parental Toothbrushing on Infants', 'timeFrame': '12 months', 'description': "Proportion of parents who brushed their infants' teeth regularly twice daily at 12 months"}], 'secondaryOutcomes': [{'measure': 'Feeding Habits on Infants', 'timeFrame': '12 months', 'description': 'Proportion of infants falling asleep during milk-feeding'}, {'measure': 'Ratio of Mutans Streptococci (MS)', 'timeFrame': '24 months', 'description': 'Proportion of MS with respect to the total bacterial count'}, {'measure': "Mothers' Gingival Bleeding", 'timeFrame': '12 months', 'description': 'Percentage of probing sites with gingival bleeding (BOP%, range 0-100%)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Early childhood caries (ECC)', 'Oral health promotion', 'Randomized controlled trial'], 'conditions': ['Dental Caries']}, 'referencesModule': {'references': [{'pmid': '34515552', 'type': 'DERIVED', 'citation': 'Yu KF, Wen W, Liu P, Gao X, Lo ECM, Wong MCM. Effectiveness of Family-Centered Oral Health Promotion on Toddler Oral Health in Hong Kong. J Dent Res. 2022 Mar;101(3):286-294. doi: 10.1177/00220345211036663. Epub 2021 Sep 13.'}, {'pmid': '33066773', 'type': 'DERIVED', 'citation': 'Liu P, Wen W, Yu KF, Gao X, Lo ECM, Wong MCM. Effectiveness of a family-centered behavioral and educational counselling approach to improve periodontal health of pregnant women: a randomized controlled trial. BMC Oral Health. 2020 Oct 16;20(1):284. doi: 10.1186/s12903-020-01265-6.'}]}, 'descriptionModule': {'briefSummary': "Early childhood caries (ECC) is a global health problem that causes pain and infection to the children affected. It is a common disease among preschool children in Hong Kong. There is a great need to improve at-home ECC preventive measures through oral health promotional activities as early as possible to parents.\n\nThe investigators will propose a 4-year randomized controlled trial of family-centered oral health promotion for new parents which aims to increase the proportion of parents brushing their infants' teeth at 1 year, establishing proper feeding and dietary habits, reducing the transfer of MS from the parents to their infants and then reducing the risk of ECC of the children at 3 years. The investigators also aim to improve the oral hygiene status of the new parents and prevention of oral diseases among themselves.\n\nFirst-time expectant mothers and their husbands will be recruited. The recruited families will be randomly allocated to the test and control groups. In the test group, personal hygiene instruction (OHI) for the expectant mothers and their husbands together with oral health education materials on infant's tooth development and eruption, establishment of proper feeding, dietary and toothbrushing habits will be given before the delivery of the new born babies. Reinforcement of OHI and demonstrations on how to clean the infant's oral cavities and perform toothbrushing will be delivered after the babies are born. Comprehensive data will be collected from the mothers, fathers and the infants in both the test and control groups at different time points through dental examination, biological testing and questionnaire survey. The CONSORT statement will be strictly followed when conducting the clinical trial, analyzing the data and reporting the results.\n\nIt is anticipated that the effectiveness of oral health promotion starting at the pregnancy period and for both expecting mothers and their husbands will be greater in preventing the infants from developing ECC. Furthermore, establishing good oral health care habits will have long term benefits, helping safeguard the oral health of the children as they grow and the family as a whole. This study will also provide much needed evidence for the further development of oral health policies and oral health promotion programmes in Hong Kong; specifically how these can be integrated into family health education so as to achieve a higher effectiveness. This will contribute significantly to the improvement of oral health in the population of Hong Kong."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First-time pregnancy\n* Of Chinese ethnicity\n* Ability to speak Cantonese and read traditional Chinese\n\nExclusion Criteria:\n\n* Pregnant women with any communication difficulties noted\n* Informed consent not obtained'}, 'identificationModule': {'nctId': 'NCT02937194', 'briefTitle': 'Family-centered Oral Health Promotion for New Parents', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Family-centered Oral Health Promotion for New Parents and Their Infants: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'GRF HKU 782213M'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Personal oral health instruction + pamphlets distribution', 'description': "Personal oral health instruction (OHI) for the expectant mothers and their husbands together with oral health education materials on infant's tooth development and eruption, establishment of proper feeding, dietary and toothbrushing habits will be given before baby delivery. Reinforcement of OHI and demonstrations on how to clean the infant's oral cavities and perform toothbrushing will be delivered after the babies are born.", 'interventionNames': ['Behavioral: Personal oral health instruction + pamphlets distribution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pamphlets distribution', 'description': "Pamphlets for adults' and pregnant women's oral health care will be distributed when recruited and information on the babies' oral health care will be distributed before baby delivery.", 'interventionNames': ['Behavioral: Pamphlets distribution']}], 'interventions': [{'name': 'Personal oral health instruction + pamphlets distribution', 'type': 'BEHAVIORAL', 'description': 'Personal oral health instruction (OHI) and oral health pamphlets distribution', 'armGroupLabels': ['Personal oral health instruction + pamphlets distribution']}, {'name': 'Pamphlets distribution', 'type': 'BEHAVIORAL', 'description': 'Oral health pamphlets distribution', 'armGroupLabels': ['Pamphlets distribution']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'China', 'facility': 'The University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hong Kong Government', 'class': 'OTHER_GOV'}, {'name': 'Hospital Authority, Hong Kong', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Professor May C.M. Wong', 'investigatorAffiliation': 'The University of Hong Kong'}}}}