Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 3:11 AM
Study NCT ID:
NCT07395167
Status:
COMPLETED
Last Update Posted:
2026-02-09
First Post:
2026-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
This Study Aims to Evaluate the Soft Tissue Response and Prosthetic Complications Associated With Three Different Types of Provisional Prosthesis Used in Immediate Loading Full-arch Implant Prosthetic Treatment. The Patients Are Randomly Assigned to the Three Groups to Compare the Clinical Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-03', 'studyFirstSubmitDate': '2026-01-10', 'studyFirstSubmitQcDate': '2026-02-03', 'lastUpdatePostDateStruct': {'date': '2026-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical evaluation of dental implant (bone Level)', 'timeFrame': '3 months', 'description': 'Evaluation included alveolar bone level around implant which is evaluated using periapical x-rays comparing T0 (at implant insertion) to T1 ( at one and half month) and T2 (at three months ) measuring amount of bone resorption around implant'}], 'secondaryOutcomes': [{'measure': 'modified plaque index', 'timeFrame': '3 months', 'description': 'the Modified Plaque Index (MPI) to assess peri-implant biofilm at four surfaces using scores from 0 (no plaque) to 3 (abundant plaque) using periodontal probe.'}, {'measure': 'the Modified Gingival Index (MGI)', 'timeFrame': '3 months', 'description': 'evaluate peri-implant soft tissue inflammation, scored from 0 (healthy mucosa) to 3 (severe inflammation)'}, {'measure': 'peri-implant probing depth (PD)', 'timeFrame': '3 months', 'description': 'measured with pressure-sensitive probes, where an increase over time indicates possible bone loss, with an ideal sulcus depth of less than 5 mm to allow effective oral hygiene'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Immediate Provisional Prosthesis']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the soft tissue response and prosthetic complications associated with three different types of provisional prostheses used in immediate loading full-arch implant prosthetic treatment. The patients are randomly assigned to the three groups to compare the clinical outcomes and determine which provisional prosthesis provides better soft tissue health and fewer prosthetic complications'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- In good general health. Controlled systemic diseases such as well-managed diabetes or hypertension. Good oral hygiene Adequate bone quality and quantity (Type I-III bone, ≥10mm height, ≥6mm width).\n\nExclusion Criteria:\n\n* Uncontrolled systemic diseases Bone insufficiency Active infection or periodontal disease. Pregnancy. Heavy smokers (\\>10 cigarettes/day). History of previous implant failure in the same site. Immunocompromised patients (e.g., HIV, recent radiation therapy'}, 'identificationModule': {'nctId': 'NCT07395167', 'briefTitle': 'This Study Aims to Evaluate the Soft Tissue Response and Prosthetic Complications Associated With Three Different Types of Provisional Prosthesis Used in Immediate Loading Full-arch Implant Prosthetic Treatment. The Patients Are Randomly Assigned to the Three Groups to Compare the Clinical Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Evaluation of Soft Tissue Response and Prosthetic Complication of Three Different Provisional Prosthesis Used for Immediate Load Full Arch Implant Prosthesis. Randomized Control Clinical Trial', 'orgStudyIdInfo': {'id': 'A08012024RP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Printed provisional', 'description': 'patients received 3D printed provisional full arch prosthesis', 'interventionNames': ['Device: 3D printed provisional full arch prosthesis']}, {'type': 'EXPERIMENTAL', 'label': 'Bar reinforced provisional', 'description': 'patients received Bar reinforced 3D printed provisional full arch prosthesis.', 'interventionNames': ['Device: Bar reinforced 3D printed provisional full arch prosthesis']}, {'type': 'EXPERIMENTAL', 'label': 'Milled provisional', 'description': 'patient received Milled PMMA provisional full arch prosthesis.', 'interventionNames': ['Device: Milled PMMA provisional full arch prosthesis']}], 'interventions': [{'name': '3D printed provisional full arch prosthesis', 'type': 'DEVICE', 'description': 'patients received 3D printed provisional full arch prosthesis after implant placement', 'armGroupLabels': ['Printed provisional']}, {'name': 'Bar reinforced 3D printed provisional full arch prosthesis', 'type': 'DEVICE', 'description': 'patients received bar reinforced 3D printed provisional full arch prosthesis after implant placement', 'armGroupLabels': ['Bar reinforced provisional']}, {'name': 'Milled PMMA provisional full arch prosthesis', 'type': 'DEVICE', 'description': 'patients received Milled PMMA provisional full arch prosthesis after implant placement', 'armGroupLabels': ['Milled provisional']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35511', 'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Mansoura university faculty of dentistry', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}