Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2026-02-25 @ 11:48 PM
Study NCT ID:
NCT06341959
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-02-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Can a Low-threshold Check-up Motivate Older People to Schedule a Dental Visit?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009059', 'term': 'Mouth Diseases'}], 'ancestors': [{'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008403', 'term': 'Mass Screening'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006306', 'term': 'Health Surveys'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D015980', 'term': 'Public Health Practice'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-03-25', 'size': 743439, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2024-03-25T05:59', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "The intervention group will be provided with tools to facilitate dental contact and will be informed about the importance of regular dental visits. Participants are given the opportunity to receive an oral examination. Afterwards, each participant will receive brochures with oral hygiene instructions to take home. Participants will receive information about any identified oral pathology. A referral letter for the dentist and a report for the general practitioner will also be prepared to increase social influence. If the participant doesn't have a dentist, the participant will receive a list of contact information for dentists in the area.\n\nIn the control group, no oral examination will be performed. However, participants will be given a list of nearby dentists and flyers with oral hygiene instructions."}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 194}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-17', 'studyFirstSubmitDate': '2024-02-06', 'studyFirstSubmitQcDate': '2024-03-27', 'lastUpdatePostDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Contacted a dentist', 'timeFrame': '4 months', 'description': 'Number of participants that have contacted a dentist within 4 months.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oral Disease']}, 'referencesModule': {'references': [{'pmid': '39833951', 'type': 'DERIVED', 'citation': 'De Vleeschauwer A, Poppe L, Colman R, Janssens B. Can a low-threshold check-up motivate older adults to schedule a dental visit? Study protocol for a randomized controlled trial. Trials. 2025 Jan 20;26(1):23. doi: 10.1186/s13063-025-08728-7.'}]}, 'descriptionModule': {'briefSummary': 'There is little research on the effect of oral screening campaigns for improving oral health in older people. Therefore, the aim of this study is to investigate the effect of a low-threshold contact with an oral health professional, including an oral health examination, on dental attendance of older people (65 years of age or older).', 'detailedDescription': "The intervention group will be provided with tools to facilitate dental contact and will be informed about the importance of regular dental visits. Participants are given the opportunity to receive an oral examination. Afterwards, each participant will receive brochures with oral hygiene instructions to take home. Participants will receive information about any identified oral pathology. A referral letter for the dentist and a report for the general practitioner will also be prepared to increase social influence. If the participant doesn't have a dentist, the participant will receive a list of contact information for dentists in the area.\n\nIn the control group, no oral examination will be performed. However, participants will be given a list of nearby dentists and flyers with oral hygiene instructions.\n\nIn this way, we want to find out whether the presence of a dental professional with tailored advice is crucial to motivate an elderly person to good oral care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* 65 years of age or older\n* home-dwelling within the selected regions (ELZ RITS en ELZ Scheldekracht)\n* Dutch speaking\n* no dental check-up in the last 12 months\n* sufficient cognitive ability to answer the questions\n\nExclusion criteria:\n\n\\- Failure to meet inclusion criteria'}, 'identificationModule': {'nctId': 'NCT06341959', 'briefTitle': 'Can a Low-threshold Check-up Motivate Older People to Schedule a Dental Visit?', 'organization': {'class': 'OTHER', 'fullName': 'University Ghent'}, 'officialTitle': 'Can a Low-threshold Check-up Motivate Older People to Schedule a Dental Visit? A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'GerodentPLUS1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': "The intervention group will be provided with tools to facilitate dental contact and will be informed about the importance of regular dental visits. Participants are given the opportunity to receive an oral examination. Afterwards, each participant will receive brochures with oral hygiene instructions to take home. Participants will receive information about any identified oral pathology. A referral letter for the dentist and a report for the general practitioner will also be prepared to increase social influence. If the participant doesn't have a dentist, the participant will receive a list of contact information for dentists in the area.", 'interventionNames': ['Procedure: Oral screening']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'In the control group, no oral examination will be performed. However, participants will be given a list of nearby dentists and flyers with oral hygiene instructions.'}], 'interventions': [{'name': 'Oral screening', 'type': 'PROCEDURE', 'description': "The participants in the intervention group will receive an oral examination. Subsequently, information about any identified problem will be given. Lastly, participants will receive a referral letter for their dentist and a report for the general practitioner. If the participants don't have a regular dentist, they will also be given a list with contact information of dentists in the area.", 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Aster De Vleeschauwer', 'role': 'CONTACT', 'email': 'aster.devleeschauwer@ugent.be'}, {'name': 'Barbara barbarae.janssens@ugent.be, Prof. dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UGent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'centralContacts': [{'name': 'Aster De Vleeschauwer', 'role': 'CONTACT', 'email': 'aster.devleeschauwer@ugent.be', 'phone': '+32470475369'}, {'name': 'Barbara Janssens', 'role': 'CONTACT', 'email': 'barbarae.janssens@ugent.be', 'phone': '+32473615130'}], 'overallOfficials': [{'name': 'Barbara Janssens', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Ghent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Privacy of the participants'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}