Ignite Creation Date:
2025-12-24 @ 4:38 PM
Ignite Modification Date:
2026-01-01 @ 5:20 PM
Study NCT ID:
NCT06164366
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-11
First Post:
2023-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Satisfaction and Adaptation of Dentures Printed at 0 Versus 45 Degrees
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007575', 'term': 'Jaw, Edentulous'}], 'ancestors': [{'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009066', 'term': 'Mouth, Edentulous'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-01', 'studyFirstSubmitDate': '2023-08-06', 'studyFirstSubmitQcDate': '2023-12-01', 'lastUpdatePostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'patient satisfaction', 'timeFrame': '6 months', 'description': 'Measured through a questionnaire using a likert scale from 1 - 5 with 1 being extremely satisfied with the intervention and 5 being extremely satisfied with the intervention'}, {'measure': 'denture adaptation', 'timeFrame': '4 weeks', 'description': 'measured using 3d metrology software in terms of the root mean square (RMS) values of trueness and adaptation'}], 'secondaryOutcomes': [{'measure': 'Denture retention', 'timeFrame': '6 months', 'description': 'Measured using Kapur scoring system. The grading will follow a Scoring System with four possible scores for retention from least (0) to best retention (3)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Edentulous Jaw']}, 'descriptionModule': {'briefSummary': 'This pilot study aims to compare the difference, if present in patient satisfaction, denture base adaptation and retention in 3d printed maxillary complete dentures fabricated at a build angle of 0 degrees versus 45 degrees.', 'detailedDescription': 'This pilot study aims to compare the difference, if present in patient satisfaction, denture base adaptation and retention in 3d printed maxillary complete dentures fabricated at a build angle of zero degrees versus forty five degrees. Since there is no sufficient evidence surrounding the topic at hand, a randomized clinical trial must be conducted in an attempt to gap the clinical knowledge regarding printing orientation and its effect on denture base adaptation and patient satisfaction. The main question and the one that needs further investigations as stated by Goodacre would these differences in these build up angles have a true clinical effect on denture adaptation and denture retention'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients above the age of 40\n2. Patients with opposing full natural dentition or completely or partially edentulous arches\n3. Opposing arch should be either having a set of full natural dentition or is restored by fixed partial dentures or implants\n4. Cooperative patients that are willing to attend all follow-up periods.\n5. Patients with healthy attached mucosa of appropriate thickness free from any inflammation.\n\n6- Patients free from any systemic disease that might affect the health of the bone or of the mucosa eg diabetes\n\nExclusion Criteria:\n\n1. Patients with any temporomandibular joint disorder or parafunctional habits\n2. Patients with flabby or flat ridges\n3. Patients with extreme anatomical limitations such as a large torus that requires surgical excision.\n4. Patients with a history of allergy to dentures made of resins.\n5. Patients with pathological changes of residual ridges as recurrent or persistent ulcers, osteomyelitis and infections.\n6. Patients with medical or psychological conditions as physical disability or mental retardation that hinder cooperation in the follow up visits and answering the questionnaires.'}, 'identificationModule': {'nctId': 'NCT06164366', 'briefTitle': 'Patient Satisfaction and Adaptation of Dentures Printed at 0 Versus 45 Degrees', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Patient Satisfaction and Adaptation of Maxillary Resin Dentures Printed at 0 Versus 45 Degrees Build Angle: A Randomized Pilot Cross-over Clinical Trial', 'orgStudyIdInfo': {'id': '245326677'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '0 Degrees Group', 'description': 'dentures will be printed at a 0 degrees build angle', 'interventionNames': ['Device: 0 degrees 3D printed upper complete dentures']}, {'type': 'ACTIVE_COMPARATOR', 'label': '45 Degrees Group', 'description': 'dentures will be printed at a 45 degrees build angle', 'interventionNames': ['Device: 45 degrees 3D printed upper complete dentures']}], 'interventions': [{'name': '0 degrees 3D printed upper complete dentures', 'type': 'DEVICE', 'description': '3d printed dentures at a build angle of 0 degrees', 'armGroupLabels': ['0 Degrees Group']}, {'name': '45 degrees 3D printed upper complete dentures', 'type': 'DEVICE', 'description': '3d printed dentures at a build angle of 45 degrees', 'armGroupLabels': ['45 Degrees Group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Iman Abd-ElWahab Radi, PhD', 'investigatorAffiliation': 'Cairo University'}}}}