Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-28 @ 5:08 AM
Study NCT ID:
NCT06031168
Status:
UNKNOWN
Last Update Posted:
2023-09-11
First Post:
2023-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
1% Metformin Gel-coated Implants and Osteointegration and Crestal Marginal Bone Loss
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': 26}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-09-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-03', 'studyFirstSubmitDate': '2023-09-03', 'studyFirstSubmitQcDate': '2023-09-03', 'lastUpdatePostDateStruct': {'date': '2023-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in implant stability', 'timeFrame': 'Baseline and 4 months', 'description': 'stability will be assessed by using ostell device'}], 'secondaryOutcomes': [{'measure': 'change in marginal bone loss', 'timeFrame': 'Baseline and 4 months', 'description': 'To evaluate the amount of bone loss around osseointegrated implants all patient will be subjected to periapical x-ray.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteointegration']}, 'descriptionModule': {'briefSummary': 'Achieving and maintaining a long term osseointegrated dental implant is a golden goal of success in field of dentistry. Osteointegration depends on surface treatment of dental implants. various techniques of implant coating have been introduced to enhance and accelerate osteointegration. The purpose of present study is to clinically and radiographically evaluate the osseointegration around hydrophilic dental implants coated with 1% Metformin gel Materials and Methods: We executed a randomized controlled clinical trial. The sample will include patients demanding dental implant treatment. Patients will be randomly allocated into the two groups of the study. The group A will be treated with 1% concentrated metformin gel coated hydrophilic dental implant. Group B will be treated with uncoated hydrophilic dental implant. The primary outcome variable will be implant osteointegration and crestal marginal bone loss around implants. It will be measured at time of implant placement and reevaluated after 4, 6-months with periapical x-ray and 3-dimensional imaging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Good general periodontal health and maintenance.\n* Adequate amount of bone volume at implant site, allowing to perform the dental implant surgery procedure without bone grafting techniques\n\nExclusion criteria\n\n* Heavy smokers who smoke more than ten cigarettes per day\n* Diabetic patients who have received metformin as antidiabetic drug\n* local or systemic conditions that will interfere with routine implant placement (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': 'NCT06031168', 'briefTitle': '1% Metformin Gel-coated Implants and Osteointegration and Crestal Marginal Bone Loss', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Evaluation the Effect of Topically Coated Dental Implants With 1% Metformin Gel on Osteointegration and Crestal Marginal Bone Loss (a Randomized Controlled Clinical Trial)', 'orgStudyIdInfo': {'id': 'Implants_2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test group', 'interventionNames': ['Other: Metformin gel coated implants']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'interventionNames': ['Other: uncoated hydrophilic dental implants']}], 'interventions': [{'name': 'Metformin gel coated implants', 'type': 'OTHER', 'description': 'Patients will be treated with 1% concentrated metformin gel coated hydrophilic dental implant.', 'armGroupLabels': ['Test group']}, {'name': 'uncoated hydrophilic dental implants', 'type': 'OTHER', 'description': 'Patients treated by uncoated implants', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed Adel, BDS', 'role': 'CONTACT', 'email': 'adelo.free81@gmail.com', 'phone': '01142212300'}, {'name': 'Mohamed Adel, BDS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Alexandria Faculty of Dentistry', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'centralContacts': [{'name': 'Mohamed Adel, BDS', 'role': 'CONTACT', 'email': 'adelo.free81@gmail.com', 'phone': '01142212300'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hams Hamed Abdelrahman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer of DPH and Clinical statistician', 'investigatorFullName': 'Hams Hamed Abdelrahman', 'investigatorAffiliation': 'Alexandria University'}}}}