Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-01-02 @ 2:45 AM
Study NCT ID:
NCT07031856
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-22
First Post:
2025-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Clinical Performance of Partial Restorations Fabricated With Three-Dimensional Printer and CAD-CAM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}, {'id': 'D014076', 'term': 'Tooth Diseases'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-19', 'studyFirstSubmitDate': '2025-05-20', 'studyFirstSubmitQcDate': '2025-06-19', 'lastUpdatePostDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical performance of dental restorations evaluated using FDI World Dental Federation criteria', 'timeFrame': 'Baseline, six months, 12 months', 'description': 'Esthetic Properties Color match (shade stability) Surface staining Translucency/opacity Anatomical form preservation Functional Properties Fracture and retention Marginal adaptation (gap formation) Wear resistance Occlusal contact stability Biological Properties (Newly added) Postoperative hypersensitivity (pulp reactions) Secondary caries development Periodontal response (gingival inflammation, bleeding on probing) Tooth integrity (adjacent tooth structure)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Caries', 'Dental Restoration, Permanent', 'Tooth Diseases']}, 'descriptionModule': {'briefSummary': 'The aim of this clinical study is to compare CAD-CAM and 3D restorations in individuals with two hard tissue losses or restorations in their mouths. The main question it aims to answer is: Is there a difference between CAD-CAM and 3D restorations according to FDI criteria? Researchers will compare participants to see if there is a difference between the two restorations according to FDI criteria. In this split-mouth study, participants will be randomized to receive a CAD-CAM partial restoration on one tooth and a 3D partial restoration on the other tooth.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'İncluiding:\n\n\\-- Patients with periodontally stable and appropriate oral hygiene habits without serious systemic diseases that preclude restoration. - Male and female patients with hard tissue loss in their mouth or with 2 teeth in need of restoration replacement (eligibility for split-mouth design). - People who can comply with the treatment and volunteer for follow-up for 2 years-\n\nExclusion Criteria:\n\nPatients with systemic conditions that may affect the study process (e.g. diabetes, autoimmune diseases).\n\n* Patients with excessive bruxism or parafunctional habits.\n* Pregnant or lactating women.\n* Patients with gum disease or severe bone loss.\n* Patients with a history of allergic reactions.'}, 'identificationModule': {'nctId': 'NCT07031856', 'briefTitle': 'Comparison of Clinical Performance of Partial Restorations Fabricated With Three-Dimensional Printer and CAD-CAM', 'organization': {'class': 'OTHER', 'fullName': 'Cukurova University'}, 'officialTitle': 'Comparison of Clinical Performance of Partial Restorations Fabricated With Three-Dimensional Printer and CAD-CAM: A Split-Mouth Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'T.C. Ç.Ü BAP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3D printer partial crown', 'description': 'Participant with restoration produced with 3D printer', 'interventionNames': ['Other: 3D printer partial crown']}, {'type': 'OTHER', 'label': 'Cad-Cam partial crown', 'description': 'Participant with restoration produced with Cad-Cam', 'interventionNames': ['Other: Treatment as usual']}], 'interventions': [{'name': '3D printer partial crown', 'type': 'OTHER', 'description': 'Comprasion of partial restorations made with 3D printer', 'armGroupLabels': ['3D printer partial crown']}, {'name': 'Treatment as usual', 'type': 'OTHER', 'description': 'Cad-cam printer partial crown', 'armGroupLabels': ['Cad-Cam partial crown']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Research Assistant', 'role': 'CONTACT', 'email': 'yarenncoskun@gmail.com', 'phone': '+90 0544 745 8633'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cukurova University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Yaren Cosgun', 'investigatorAffiliation': 'Cukurova University'}}}}