Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-01-01 @ 7:36 PM
Study NCT ID:
NCT05031156
Status:
UNKNOWN
Last Update Posted:
2021-09-01
First Post:
2021-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Splinted and Unsplinted OT Bridge Systems in Screw Retained Implant Restoration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-06-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-29', 'studyFirstSubmitDate': '2021-08-29', 'studyFirstSubmitQcDate': '2021-08-29', 'lastUpdatePostDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Marginal Bone loss', 'timeFrame': '3 monts', 'description': 'Measures the changes around the dental implants along the healing period using paralleling technique radiograph and DIGORA system'}], 'secondaryOutcomes': [{'measure': 'Early implant failure', 'timeFrame': '3 months', 'description': 'not fulfilling one of Alberksston implant success criteria'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Evaluate the Immediate Loading Implants in All on 4 Cases Using Conversion Denture and OT Bridge System']}, 'descriptionModule': {'briefSummary': 'Evaluation of Bone level changes around dental implants in All on 4 cases with immediate loading using conversion denture and OT Bridge system either splinted or not'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any completely edentulous patient (mandible) with an old satisfactory denture requiring an implant-supported restoration.\n* Patients aged from 40 to 70, able to sign an informed consent will be considered eligible for this trial.\n* Implant sites must allow the placement of four implants.\n* Non- heavy Smokers will be included (smoking up to 10 cigarettes/day)\n* In case of post-extractive sites, they must have been healed for at least 3-month before being treated in the study.\n* Patients with no systemic condition that may interfere with implant placement (e.g., Immunosuppressed or immunocompromised patients, patients under treatment of intravenous amino-bisphosphonates)\n\nExclusion Criteria:\n\n* \\- Patients with poor oral hygiene and motivation.\n* Pregnancy or nursing.\n* Drug abusers.\n* Psychiatric problems or unrealistic expectations.\n* Patients with infection and or inflammation in the area intended for implant placement.\n* Patients participating in other studies, if the present protocol cannot be properly adhered to.\n* Patients with signs of hyperactive muscles.'}, 'identificationModule': {'nctId': 'NCT05031156', 'acronym': 'OTBS', 'briefTitle': 'Splinted and Unsplinted OT Bridge Systems in Screw Retained Implant Restoration', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Mandibular Immediately Loaded, Screw-retained Splinted and Non-splinted OT Bridge Implant Restoration on Bone Height Changes of Completely Edentulous Patients (A Randomized Clinical Trial)', 'orgStudyIdInfo': {'id': 'OTBridge'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'non-splinting of OT Bridge system', 'description': 'Leaving the dental implants abutments solitary followed by denture pick up', 'interventionNames': ['Procedure: Splinting of OT Bridge system']}, {'type': 'EXPERIMENTAL', 'label': 'splinting of OT Bridge', 'description': 'Splinting of implants abutments using titanium wire then followed by denture pick up', 'interventionNames': ['Procedure: Splinting of OT Bridge system']}], 'interventions': [{'name': 'Splinting of OT Bridge system', 'type': 'PROCEDURE', 'description': "splinting of implant abutment using titanium wire followed by pick up using the patient's denture", 'armGroupLabels': ['non-splinting of OT Bridge system', 'splinting of OT Bridge']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Tasneem El Mashad, Master degree holder', 'role': 'CONTACT', 'email': 'tasneem.elmashad@gmail.com', 'phone': '01005754571', 'phoneExt': '+02'}], 'overallOfficials': [{'name': 'Tasneem El Mashad', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer of Prosthodontics', 'investigatorFullName': 'tasneem gamal youssef el mashad', 'investigatorAffiliation': 'Cairo University'}}}}