Ignite Creation Date:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2025-12-31 @ 9:25 PM
Study NCT ID:
NCT06752200
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-30
First Post:
2024-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AMOUNT OF INTRAORAL OCCLUSAL ADJUSTMENTS IN OCCLUSAL SPLINTS FABRICATED USING FULLY DIGITAL VERSUS COMBINED DIGITAL WORKFLOW IN TMD PATIENTS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Statistician'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-21', 'studyFirstSubmitDate': '2024-12-21', 'studyFirstSubmitQcDate': '2024-12-21', 'lastUpdatePostDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The amount of intraoral occlusal adjustments (represented by the 3-dimension volumetric changes)', 'timeFrame': '5 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['TMD']}, 'descriptionModule': {'briefSummary': 'Each eligible patient will be randomly into one of two groups:\n\ngroup A: Occlusal splints fabricated using a fully digital workflow including the use of a jaw tracking device.\n\ngroup B: Occlusal splints fabricated using a combined digital workflow using a conventional bite technique.\n\nThe intervention involves the fabrication of 3D printing of occlusal splint with fully digitalization technique by the aid of Jaw Tracing Device (Zebis JMA, Germany). The acquisition and scanning of the patients are done by using an intra oral scanner (Medit i700, South Korea) and designing them using a designing software (Exocad, USA). This device will be printed with a 3D printer (Anycubic, China) utilizing printable resin material with codes for which the outcome assessor is kept totally unaware.\n\nFor the comparator group, upper and lower arches will be scanned intraorally. The bite will be registered at centric by using rubber base bite registration material after patient deprogramming with Lucia jig. Then the bite will be scanned.\n\nThe splint will be designed and printed in the same workflow as the intervention group.\n\nThe amount of intraoral occlusal adjustments (represented by the 3-dimension volumetric changes) will be measured by Medit link by millimeters before the splint insertion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) 18-40 years old\n\n (2) Complete dentition.\n\n (3) Normal jaw opening.\n\n (4) Intact teeth.\n\n (5) No occlusal disorder; stable jaw relation.\n\n (6) No ongoing dental therapy, such as orthodontic or prosthodontic treatment.\n\n (7) TMD patients with more than one of following symptoms or signs: myofascial pain and /or pain in the TMJ, myofascial pain and/or pain in the TMJ on palpation, muscles tenderness, headache or earache.\n\n (8) Patients who had unsuccessfully undergone splint therapy or other TMD treatments in the past were not excluded.\n\nExclusion Criteria:\n\n* (1) Patients with an unstable occlusion\n\n (2) Patients with systemic diseases and comorbidities\n\n (3) Temporomandibular joint lesions found on clinical palpation or medical imaging examination\n\n (4) Jaw opening less than 3 fingers\n\n (5) Patients with occlusal dysfunctions\n\n (6) Patients with severe or moderate periodontitis\n\n (7) Unable to undergo examination or treatment due to the presence of a psychological or mental disorder.'}, 'identificationModule': {'nctId': 'NCT06752200', 'briefTitle': 'AMOUNT OF INTRAORAL OCCLUSAL ADJUSTMENTS IN OCCLUSAL SPLINTS FABRICATED USING FULLY DIGITAL VERSUS COMBINED DIGITAL WORKFLOW IN TMD PATIENTS', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'AMOUNT OF INTRAORAL OCCLUSAL ADJUSTMENTS IN OCCLUSAL SPLINTS FABRICATED USING FULLY DIGITAL VERSUS COMBINED DIGITAL WORKFLOW IN TMD PATIENTS (RANDOMIZED CONTROLLED TRIAL)', 'orgStudyIdInfo': {'id': 'D Ro 3_3_1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Occlusal splints fabricated using a fully digital workflow including the use of a jaw tracking devic', 'description': 'The intervention involves the fabrication of 3D printing of occlusal splint with fully digitalization technique by the aid of Jaw Tracing Device (Zebis JMA, Germany).', 'interventionNames': ['Device: Occlusal splints fabricated using a fully digital workflow including the use of a jaw tracking device.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Occlusal splints fabricated using a combined digital workflow using a conventional bite technique.', 'description': 'For the comparator group, upper and lower arches will be scanned intraorally. The bite will be registered at centric by using rubber base bite registration material after patient deprogramming with Lucia jig. Then the bite will be scanned. The splint will be designed and printed in the same workflow as the intervention group.', 'interventionNames': ['Device: Occlusal splints fabricated using a combined digital workflow using a conventional bite technique']}], 'interventions': [{'name': 'Occlusal splints fabricated using a fully digital workflow including the use of a jaw tracking device.', 'type': 'DEVICE', 'description': 'Occlusal splints fabricated using a fully digital workflow including the use of a jaw tracking device.', 'armGroupLabels': ['Occlusal splints fabricated using a fully digital workflow including the use of a jaw tracking devic']}, {'name': 'Occlusal splints fabricated using a combined digital workflow using a conventional bite technique', 'type': 'DEVICE', 'description': 'upper and lower arches will be scanned intraorally. The bite will be registered at centric by using rubber base bite registration material after patient deprogramming with Lucia jig. Then the bite will be scanned. The splint will be designed and printed in the same workflow as the intervention group.', 'armGroupLabels': ['Occlusal splints fabricated using a combined digital workflow using a conventional bite technique.']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Salma A Tantawy, Master of prosthodontics', 'role': 'CONTACT', 'email': 'Salma.tantawy@dentistry.cu.edu.eg', 'phone': '+20100357380'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'I am not going to share the IPD for privacy and security of the informations'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Teacher assistant', 'investigatorFullName': 'Salma abd el fattah abbass sayed tantawy', 'investigatorAffiliation': 'Cairo University'}}}}