Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-03-08 @ 1:06 AM
Study NCT ID:
NCT06422260
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-05-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Four-unit Implant Supported Fixed Partial Dentures Fabricated From Different Materials
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011475', 'term': 'Prosthesis Failure'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'targetDuration': '4 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-01-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-17', 'studyFirstSubmitDate': '2024-05-08', 'studyFirstSubmitQcDate': '2024-05-17', 'lastUpdatePostDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone loss', 'timeFrame': '4 years', 'description': 'Measurement of alveolar bone loss around implants.'}], 'secondaryOutcomes': [{'measure': 'Clinical performance of the prosthesis superstructure', 'timeFrame': '4 years', 'description': 'Such as fracture of the prosthesis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prosthesis Survival', 'Bone Loss']}, 'descriptionModule': {'briefSummary': 'Implant supported superstructure is necessary for long term success and durability of the implant itself in terms of stresses distribution and fracture strength capability. Stresses falling on an implant are too much greater than those applied on a tooth structure with a periodontal ligament offering a degree of elasticity. The important mechanical and physical properties of materials used for the fabrication of dental prostheses include adequate flexural and tensile strength and modulus of elasticity, maximum fracture resistance, optimal bond strength and adequate polishability.', 'detailedDescription': 'One objective of implant dentistry is to provide excellent esthetics and soft-tissue profiles in the esthetic zone. Esthetic requirements have focused primarily on the position, inclination, shape, and color of the restoration. However, the peri-implant soft tissue also plays a major role in the esthetics of an implant-supported restoration especially in the anterior region.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '60 participants who needed an implant-supported fixed partial denture (FPD) in the esthetic zone.', 'eligibilityCriteria': "Inclusion Criteria:\n\n* No systemic diseases that might alter the tissue response to implantation.\n* Mobility grade 3 at the site of the 4 lateral incisors.\n* sufficient available inter-arch space\n* normal maxillomandibular relation.\n* no temporomandibular joint\n\nExclusion Criteria:\n\n* Grade 1 or 2 mobility at the incisor's region.\n* Patients with systematic diseases that contraindicate implant placement."}, 'identificationModule': {'nctId': 'NCT06422260', 'briefTitle': 'Four-unit Implant Supported Fixed Partial Dentures Fabricated From Different Materials', 'organization': {'class': 'OTHER', 'fullName': 'Menoufia University'}, 'officialTitle': 'Clinical and Radiographic Outcomes of Four-unit Implant Supported Fixed Partial Dentures Fabricated From Different Materials', 'orgStudyIdInfo': {'id': 'ADMNF-0030324'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Porcelin fused to metal (PFM) group', 'description': 'Evaluation of biological response and clinical performance of the fixed partial denture anterior bridge constructed from PFM', 'interventionNames': ['Other: Prosthesis superstructure']}, {'label': 'Zirconia group', 'description': 'Evaluation of biological response and clinical performance of the fixed partial denture anterior bridge constructed from ceramics', 'interventionNames': ['Other: Prosthesis superstructure']}, {'label': 'Polyetheretherketone (PEEK) group', 'description': 'Evaluation of biological response and clinical performance of the fixed partial denture anterior bridge constructed from PEEK', 'interventionNames': ['Other: Prosthesis superstructure']}], 'interventions': [{'name': 'Prosthesis superstructure', 'type': 'OTHER', 'description': 'Prosthesis superstructure for 2 implant supported short span fixed bride constructed from different materials', 'armGroupLabels': ['Polyetheretherketone (PEEK) group', 'Porcelin fused to metal (PFM) group', 'Zirconia group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12345', 'city': 'Al Mansurah', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohammed A. El-Sawy', 'role': 'CONTACT', 'email': 'Dr_sawy@windowslive.com', 'phone': '161314522'}], 'facility': 'Mohammed A. El-Sawy', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': 'Mohammed A. El-Sawy, PhD', 'role': 'CONTACT', 'email': 'Dr_sawy@windowslive.com', 'phone': '01061314522'}, {'name': 'Mohammed T. Khater, PhD', 'role': 'CONTACT', 'email': 'mohamed.tarek67@dent.menofia.edu.eg', 'phone': '01003854552'}], 'overallOfficials': [{'name': 'Mohammed A. El-Sawy, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Menoufia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The result can be shared upon request from the corresponding author'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Menoufia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer, Department of prosthodontics, principle investigator', 'investigatorFullName': 'Mohammed El-Sawy', 'investigatorAffiliation': 'Menoufia University'}}}}