Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-03-01 @ 2:44 AM
Study NCT ID:
NCT06781320
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-17
First Post:
2024-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digital Occlusal Analysis and Enamel Wear Assessment in Temporomandibular Disorder Patients Treated with Fully Digital Versus Conventional Stabilization Splints
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013705', 'term': 'Temporomandibular Joint Disorders'}], 'ancestors': [{'id': 'D017271', 'term': 'Craniomandibular Disorders'}, {'id': 'D008336', 'term': 'Mandibular Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-26', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-07-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-15', 'studyFirstSubmitDate': '2024-12-30', 'studyFirstSubmitQcDate': '2025-01-15', 'lastUpdatePostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1. Occlusal Force Measurement: • Measured using OccluSense in Newtons (N).', 'timeFrame': '6 months', 'description': 'Occlusal Force Measurement:\n\n* Measured using OccluSense in Newtons (N)'}], 'secondaryOutcomes': [{'measure': 'Tooth Wear Measurement using an intraoral scanner', 'timeFrame': '6 months', 'description': 'Comparison of STL datasets using Geomagic Control X software.\n\n* Measured as % of surface overlap or deviation in microns.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['temporomandibular disorder, TMD,', 'Digital occlusal analysis', 'enamel wear assessment', 'stabilization splints'], 'conditions': ['TMD', 'Temporomandibular Disorders (TMD)']}, 'descriptionModule': {'briefSummary': 'This randomized controlled research aimed to analyse the occlusion and assist the enamel wear before and after using of the stabilization splints produced by the conventional methods with the fully digitally fabricated stabilization splints.\n\nResearch question: Will the fully digital stabilization splint offer significantly better occlusal equilibration and enamel wear compared to the conventional stabilization splint? the primary outcome will be Digital occlusal analysis, and secondary outcome will be enamel wear assessment', 'detailedDescription': 'This randomized controlled clinical trial investigates the effectiveness of fully digitally fabricated stabilization splints (FD-SS) versus conventionally manufactured stabilization splints (C-SS) in patients with temporomandibular disorders (TMD). The study focuses on two primary outcomes: digital occlusal analysis and enamel wear assessment over a 6-month period.\n\nParticipants are TMD patients aged 18-40 with stable jaw relations and intact dentition, randomly assigned (1:1) to the FD-SS or C-SS group. Digital occlusal analysis is performed using OccluSense technology, which captures bite force distribution and contact points dynamically and statically. Enamel wear is assessed quantitatively using an intraoral scanner paired with Geomagic Control X 3D software for surface matching analysis. Baseline and follow-up STL datasets are compared to quantify volumetric enamel loss with micrometer precision.\n\nIn the FD-SS group, fully digital stabilization splints are fabricated using a digital workflow that includes intraoral scanning, jaw tracking with Zebris JMA devices, and CAD/CAM design in Exocad software. Splints are manufactured using 3D printing technology. In the C-SS group, conventional splints are fabricated using alginate impressions, plaster casts, and manual adjustments on a semi-adjustable articulator.\n\nThis study aims to advance the understanding of digital technologies in managing TMD, providing evidence for their efficacy in improving occlusal balance and minimizing enamel wear.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18-40 years old\n2. complete dentition\n3. intact tooth\n4. no occlusal disorder\n5. stable jaw relation\n6. No ongoing dental therapy, such as orthodontic or prosthodontics treatment.\n\nExclusion Criteria:\n\n1. pregnant/lactating women\n2. temporomandibular joint lesions found on clinical palpation or medical imaging examination\n3. dentoalveolar pathology or ongoing treatment related to TMD\n4. jaw opening less than 3 fingers\n5. patients with occlusal dysfunctions\n6. Patients with severe or moderate periodontitis.\n7. Unable to undergo examination or treatment due to the presence of a psychological or mental disorder.\n8. Severe jaw functional limitations.\n9. Removable dentures or partially dentate patients\n10. Trauma of recent date towards face, head or neck'}, 'identificationModule': {'nctId': 'NCT06781320', 'briefTitle': 'Digital Occlusal Analysis and Enamel Wear Assessment in Temporomandibular Disorder Patients Treated with Fully Digital Versus Conventional Stabilization Splints', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Digital Occlusal Analysis and Enamel Wear Assessment in Temporomandibular Disorder Patients Treated with Fully Digital Versus Conventional Stabilization Splints: a Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '112/498'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fully Digital Stabilization Splint (FD-SS)', 'description': 'Description:\n\nParticipants in this group will receive a stabilization splint fabricated using a fully digital workflow. The intervention includes:\n\n* Intraoral scanning of the maxillary and mandibular arches to create a digital model.\n* Jaw tracking using the Zebris JMA system to record mandibular movements.\n* CAD design of the splint using Exocad software.\n* Fabrication: 3D printing technology to manufacture the splint.\n\nPurpose:\n\nThe FD-SS is designed to provide optimal occlusal stabilization, reduce TMJ stress, and minimize enamel wear over a 6-month period.\n\nDevice Name: Fully Digital Stabilization Splint (FD-SS)', 'interventionNames': ['Device: stabilization splint']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Stabilization Splint (C-SS)', 'description': 'Description:\n\nParticipants in this group will receive a stabilization splint fabricated using conventional methods. The intervention includes:\n\n* Taking alginate impressions of the maxillary and mandibular arches to create plaster casts.\n* Jaw registration using a Lucia jig and a semi-adjustable articulator for occlusal adjustment.\n* Manual fabrication of the splint using polymethyl methacrylate (PMMA) resin.\n\nPurpose:\n\nThe C-SS is designed to achieve occlusal stabilization and provide symptom relief for patients with temporomandibular disorders (TMD) over 6 months.\n\nDevice Name: Conventional Stabilization Splint (C-SS)', 'interventionNames': ['Device: stabilization splint']}], 'interventions': [{'name': 'stabilization splint', 'type': 'DEVICE', 'description': 'the patients will receive a stabilization splint fabricated using a fully digital workflow includes:\n\nIntraoral scanning of maxillary and mandibular arches to create a digital model.\n\nJaw tracking using the Zebris JMA system to record mandibular movements. CAD design of the splint using Exocad software. Fabrication of the splint via 3D printing technology. The FD-SS is designed to provide optimal occlusal stabilization, reduce TMJ stress, and minimize enamel wear over 6 months.\n\nOr the patient will receive stabilization splint fabricated using conventional methods. The intervention includes:\n\nTaking alginate impressions of maxillary and mandibular arches to create plaster casts.\n\nJaw registration using a Lucia jig and semi-adjustable articulator for proper occlusal adjustment.\n\nManual fabrication of the splint using polymethyl methacrylate (PMMA) resin. The C-SS is designed to achieve occlusal stabilization and symptom relief for TMD patients over 6 months.', 'armGroupLabels': ['Conventional Stabilization Splint (C-SS)', 'Fully Digital Stabilization Splint (FD-SS)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mohamed Sawi Mohamed Sawi, Assistant lecturer', 'role': 'CONTACT', 'email': 'drmohamedelsawi@hotmail.com', 'phone': '00201113669910'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Mohamed Sawi Mohamed', 'investigatorAffiliation': 'Minia University'}}}}