Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2026-01-04 @ 10:20 AM
Study NCT ID:
NCT06324292
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-26
First Post:
2024-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect Of Digital Smile Design on Quality Of Life In Complete Denture Wearers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003824', 'term': 'Denture, Complete'}], 'ancestors': [{'id': 'D003778', 'term': 'Dentures'}, {'id': 'D017266', 'term': 'Dental Prosthesis'}, {'id': 'D011476', 'term': 'Prosthodontics'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'The participants allocated into two groups; a conventional denture followed by a digital group (CG) and a digital denture followed by a conventional one group (DG).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-23', 'studyFirstSubmitDate': '2024-03-15', 'studyFirstSubmitQcDate': '2024-03-15', 'lastUpdatePostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'quality of life assessment', 'timeFrame': '3 months', 'description': 'OHIP-19 questionnaires for the edentulous patient will be used. A likert scale from 0 to 5 will be employed which zero will denote the \' very bad" experience with the denture and 5 will denote the "excellent" experience'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Complete Edentulism']}, 'descriptionModule': {'briefSummary': 'The aim of the current study protocol is to compare the effect of two complete dentures made for completely edentulous patients; one digitally constructed using digital smile design (DSD) and another one conventionally constructed on the patient\'s quality of life and patient\'s satisfaction.\n\nIt is a clinical trial in which two dentures will be made for each patient, one will be digitally constructed using digital smile design (DSD) and the other one using the conventional method with a washout period of 3 weeks. Each patient will receive a questionnaire "Oral Health Impact Profile -19" (OHIP -19) for the edentulous patients to evaluate his satisfaction with the denture.', 'detailedDescription': "Although the aesthetic results of digitally constructed dentures might be satisfactory for the patients, there is still little clinical evidence for the effect of using digital smile design DSD in denture construction on the patient's satisfaction. So, the objective of the current study is to find the effect of digital smile design (DSD) on quality of life in complete denture wearers compared to the conventionally created one. The current study is planned to be a crossover randomized Controlled Trial (RCT). The principal investigator, participants and the statistician will be blinded. Simple randomization of the patients in the will take place using a computer generated list (Software informer, Informer Technologies Inc) and allocated into two groups; a conventional denture followed by a digital group (CG) and a digital denture followed by a conventional one group (DG). Parallel allocation in ratio 1:1 will take place. The names of the participants in both groups will be placed in closed opaque sealed envelopes according to the computer generated list of random numbers and an envelope will be allocated to each patient. For blinding and allocation concealment, a third party rather than the authors and participants will be the only one to know the key so that the authors and the participants won't know in which group the participant will be. Afterwards, the authors will be informed by the randomization to be tabulated."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* completely edentulous patients\n* well formed edentulous ridge\n* healthy, pink, non edematous mucosa of even thickness\n\nExclusion Criteria:\n\n* heavy smokers\n* patients with parafunctional habits, temporomandibular joint disorders or orofacial motor disorders\n* patients with physicological or psychiatric condition'}, 'identificationModule': {'nctId': 'NCT06324292', 'briefTitle': 'Effect Of Digital Smile Design on Quality Of Life In Complete Denture Wearers', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Effect Of Digital Smile Design on Quality Of Life In Complete Denture Wearers: Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'FDASU-RecID112324'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'conventional denture followed by a digital one', 'description': 'the participants will receive a conventional complete denture followed by a digital one having digital smile design', 'interventionNames': ['Procedure: complete denture, CG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Digital denture followed by a conventional one', 'description': 'the participants will receive a digital complete denture having digital smile design followed by a conventional one', 'interventionNames': ['Procedure: complete denture, DG']}], 'interventions': [{'name': 'complete denture, CG', 'type': 'PROCEDURE', 'description': 'fabrication of conventional complete denture followed by a digital denture', 'armGroupLabels': ['conventional denture followed by a digital one']}, {'name': 'complete denture, DG', 'type': 'PROCEDURE', 'description': 'fabrication of digital complete denture followed by a conventional one', 'armGroupLabels': ['Digital denture followed by a conventional one']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11361', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Dentistry Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'zip': '11361', 'city': 'Cairo', 'country': 'Egypt', 'contacts': [{'name': 'ahmed MA mohamed, Bsc, Msc,MD', 'role': 'CONTACT', 'email': 'ahmedmostafa@dent.asu.edu.eg', 'phone': '01111191337', 'phoneExt': '020'}], 'facility': 'Faculty of Dentistry, Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Ahmed MA Mohamed, BSc MSc,MD', 'role': 'CONTACT', 'email': 'ahmedmostafa@dent.asu.edu.eg', 'phone': '01111191337', 'phoneExt': '020'}], 'overallOfficials': [{'name': 'Ahmed MA Mohamed, BDS MSc MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ain Shams University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Study protocol and statistical analysis plan will be available matching the criteria of the journal. However, data will be available from the corresponding author upon request once the paper is published.', 'ipdSharing': 'YES', 'description': 'Study protocol and statistical analysis plan will be available matching the criteria of the journal. However, data will be available from the corresponding author upon request once the paper is published.', 'accessCriteria': 'data will be available from the corresponding author upon request once the paper is published.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor of oral and maxillofacial prosthodontics', 'investigatorFullName': 'Ahmed Mostafa Abdelfatah', 'investigatorAffiliation': 'Ain Shams University'}}}}