Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-04 @ 9:32 PM
Study NCT ID:
NCT06665451
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-30
First Post:
2024-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Erythropoietin Gel Effect on Dental Implant Stability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-29', 'studyFirstSubmitDate': '2024-10-25', 'studyFirstSubmitQcDate': '2024-10-29', 'lastUpdatePostDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in implant stability', 'timeFrame': 'Baseline and after 6 month', 'description': 'Implant stability will be assessed by using ( AnyCheck - Implant Stability Tester ) Utilizes physical tapping technique and dumping capacity analysis to measure implant stability with precision'}], 'secondaryOutcomes': [{'measure': 'Change in marginal bone level and bone density around implants', 'timeFrame': 'Baseline and after 6 month', 'description': 'To evaluate the amount of marginal bone loss and bone density around osseointegrated implants, all patient will be subjected to Cone beam computed tomography (CBCT) immediate postoperative and after 6 months.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osseointegration']}, 'descriptionModule': {'briefSummary': '* Achieving and maintaining long-term osseointegration for dental implants is a key objective in the field of dentistry. The success of osseointegration is influenced by the surface treatment applied to dental implants. Numerous coating techniques have been developed to improve and speed up osseointegration.\n* The aim of the current study is to assess immediate dental implant stability coated with erythropoietin gel, both clinically and radiographically.\n* Materials and Methods: We conducted a randomized controlled clinical trial.The sample will include patients demanding immediate implant treatment in the anterior maxilla . Patients will be randomly allocated into the two groups of the study. The group A will be treated with erythropoietin gel coated dental implant immediately after extraction of non restorable teeth in the anterior maxilla . Group B will be treated with non coated dental implant immediately after extraction of non restorable teeth in the anterior maxilla .\n* The primary outcome variable will be implant stability and the secondary outcome will be crestal marginal bone level and bone density around implants. It will be measured at time of implant placement and reevaluated after 6-months .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All patients Should have nonrestorable teeth in the anterior maxilla indicated for extraction and seeking implant placement.\n* Good general periodontal health and maintenance.\n\nExclusion Criteria:\n\n* Heavy smokers who smoke more than ten cigarettes per day\n* Acute infected socket\n* Ant socket with wall defect.\n* Pregnency\n* Local or systemic conditions that will interfere with bone healing (uncontrolled diabetes mellitus or human immune deficiency virus infections, resonance therapy), bone disorders (hyperparathyroidism, osteoporosis, or Paget's disease.\n* Patients who had subjected to intravenous and/or oral bisphosphonate therapy."}, 'identificationModule': {'nctId': 'NCT06665451', 'briefTitle': 'Erythropoietin Gel Effect on Dental Implant Stability', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Evaluation of Erythropoietin Gel Effect on Stability of Immediate Implant ( Clinical and Radiographical Study )', 'orgStudyIdInfo': {'id': 'Implant surface modification'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test Group', 'description': 'Patients with fresh extraction sockets in the anterior maxilla will be treated by immediate implant coated by erythropoietin gel .', 'interventionNames': ['Other: Erythropoietin gel coated implants']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Patients with fresh extraction sockets in the anterior maxilla will be treated by non coated immediate implant .', 'interventionNames': ['Other: Non coated dental implants']}], 'interventions': [{'name': 'Non coated dental implants', 'type': 'OTHER', 'description': 'Patients with fresh extraction sockets in the anterior maxilla will be treated by non coated immediate implant .', 'armGroupLabels': ['Control group']}, {'name': 'Erythropoietin gel coated implants', 'type': 'OTHER', 'description': 'Patients with fresh extraction sockets in the anterior maxilla will be treated by immediate implant coated by erythropoietin gel.', 'armGroupLabels': ['Test Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '088', 'city': 'Asyut', 'state': 'Asyut Governorate', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed Mahjob Head of oral and maxillofacial surgery department', 'role': 'CONTACT', 'phone': '00201001544056'}, {'name': 'Mohamed Alaa Lecturer of OMFS', 'role': 'CONTACT', 'phone': '00201091919870'}, {'name': 'Ahmed Mohsen Principle investigator', 'role': 'CONTACT'}, {'name': 'Mohamed Mahjob Head of oral and maxillofacial surgery department', 'role': 'CONTACT'}], 'facility': 'Faculty of dental medicine Al-Azhar university', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Ahmed Mohsen Principle investigator', 'role': 'CONTACT', 'email': 'a7medmohsen453@gmail.com', 'phone': '00201020994802'}, {'name': 'Mohamed Mahjob Head of oral and maxillofacial surgery department', 'role': 'CONTACT', 'phone': '00201001544056'}], 'overallOfficials': [{'name': 'Mohamed Alaa Lecturer of OMFS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'faculty of Dental medicine Al-Azhar University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Ahmed Mohsen Farghaly', 'investigatorAffiliation': 'Al-Azhar University'}}}}