Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:57 AM
Study NCT ID:
NCT07475195
Status:
COMPLETED
Last Update Posted:
2026-03-16
First Post:
2026-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Probiotics and Denture Care in Saudi Arabia: Evaluating Knowledge, Practices, and the Future of Innovative Hygiene Solutions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013282', 'term': 'Stomatitis, Denture'}, {'id': 'D006209', 'term': 'Halitosis'}], 'ancestors': [{'id': 'D013280', 'term': 'Stomatitis'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Retained samples will include denture plaque swab samples, oral mucosal swab samples, and, for partially edentulous participants, periodontal/abutment-site plaque samples. Samples will be stored in sterile Eppendorf tubes with PBS at -80°C for microbiological analysis.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-11', 'studyFirstSubmitDate': '2026-03-08', 'studyFirstSubmitQcDate': '2026-03-11', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knowledge, awareness, and self-reported hygiene practices related to denture hygiene and oral probiotics among adult denture wearers, assessed using a validated questionnaire', 'timeFrame': 'Baseline', 'description': 'Knowledge, awareness, and self-reported hygiene practices related to denture hygiene and oral probiotics among adult denture wearers, assessed using a validated questionnaire'}], 'secondaryOutcomes': [{'measure': 'Prevalence of denture-related oral complications and bacterial/fungal colonization, assessed through clinical examination, culture (CFU), and real-time PCR', 'timeFrame': 'Baseline', 'description': 'Prevalence of denture-related oral complications and bacterial/fungal colonization, assessed through clinical examination, culture (CFU), and real-time PCR'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Denture Stomatitis', 'Dentures', 'Halitosis', 'Biofilms']}, 'descriptionModule': {'briefSummary': "The goal of this observational study is to learn about denture wearers' knowledge, awareness, and self-reported practices regarding denture hygiene and oral probiotics, and to assess whether these are associated with clinical oral findings and microbial colonization in adult denture wearers (18 years and older), including complete and partial denture users treated at King Saud University Dental Clinics within the past five years. The main questions it aims to answer are:\n\nWhat are the levels of knowledge, awareness, and practices related to denture hygiene and oral probiotics among adult denture wearers?\n\nWhat is the prevalence of denture-related oral conditions and bacterial/fungal colonization, and how are these related to denture hygiene knowledge and self-reported hygiene practices?\n\nParticipants will:\n\nComplete an electronic questionnaire in Arabic or English about demographics, denture hygiene knowledge, awareness of oral probiotics, and current denture care practices.\n\nAttend a 15-20 minute clinical visit for examination of dentures and oral mucosa.\n\nBe asked to avoid cleaning their denture for at least 12 hours before the visit.\n\nUndergo plaque sample collection from dentures and oral tissues; partially edentulous participants will also have additional samples collected from abutment areas.\n\nHave samples analyzed using real-time PCR and culture methods (CFU) to detect bacterial and fungal microorganisms."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult men and women aged 18 years or older who are currently wearing at least one removable denture (complete or partial) and who received denture treatment at King Saud University Dental Clinics/Dental University Hospital within the past five years. Participants are recruited by convenience sampling from eligible patients identified through the SALUD electronic dental records system.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdults 18 years or older\n\nCurrently wearing at least one removable denture (complete or partial)\n\nDenture received/used within the past five years\n\nWilling and able to provide informed consent\n\nExclusion Criteria:\n\nSevere systemic conditions affecting oral health, such as:\n\nUncontrolled diabetes (HbA1c \\> 7) and Immunosuppression\n\nPregnancy\n\nBreastfeeding\n\nCognitive or physical impairment that limits the ability to perform routine oral and denture care practices'}, 'identificationModule': {'nctId': 'NCT07475195', 'briefTitle': 'Oral Probiotics and Denture Care in Saudi Arabia: Evaluating Knowledge, Practices, and the Future of Innovative Hygiene Solutions', 'organization': {'class': 'OTHER', 'fullName': 'King Saud University'}, 'officialTitle': 'Oral Probiotics and Denture Care in Saudi Arabia: Evaluating Knowledge, Practices, and the Future of Innovative Hygiene Solutions', 'orgStudyIdInfo': {'id': 'E-25-9941'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Removable partial denture wearers', 'description': 'Patients with removable partial dentures', 'interventionNames': ['Other: This is a cross-sectional observational study. Participants are not assigned to any treatment or preventive intervention.']}, {'label': 'Complete denture wearers', 'description': 'Patients with complete denture', 'interventionNames': ['Other: This is a cross-sectional observational study. Participants are not assigned to any treatment or preventive intervention.']}], 'interventions': [{'name': 'This is a cross-sectional observational study. Participants are not assigned to any treatment or preventive intervention.', 'type': 'OTHER', 'description': 'This is a cross-sectional observational study. Participants are not assigned to any treatment or preventive intervention. They will only undergo questionnaire completion, clinical examination, and noninvasive plaque and mucosal sample collection.', 'armGroupLabels': ['Complete denture wearers', 'Removable partial denture wearers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12786', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'King Saud University', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Saud University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'yasser fahad alrayyes', 'investigatorAffiliation': 'King Saud University'}}}}