Ignite Creation Date:
2025-12-24 @ 4:22 PM
Ignite Modification Date:
2025-12-31 @ 6:54 PM
Study NCT ID:
NCT06976866
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-16
First Post:
2025-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Topical Application of Atorvastatin Gel Versus Hyaluronic Acid on Immediate Loading Dental Implant in Posterior Maxilla
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': ['CARE_PROVIDER']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-05-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-09', 'studyFirstSubmitDate': '2025-04-22', 'studyFirstSubmitQcDate': '2025-05-09', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical evaluation', 'timeFrame': '6 months', 'description': 'Clinical evaluation of implant stability was performed at the time of implant insertion and after 3 and 6 months postoperative.'}, {'measure': 'clinical evaluation', 'timeFrame': '6 months', 'description': 'Clinical evaluation of implant stability was performed at the time of implant insertion and after 3 and 6 months postoperative. Also, peri-implant pocket depth (PPD) and modified sulcus bleeding index (mSBI) were evaluated.'}, {'measure': 'clinical evaluation', 'timeFrame': '6 months', 'description': 'peri-implant pocket depth (PPD) around the implant at 3 months and 6 months after loading'}], 'secondaryOutcomes': [{'measure': 'radiographic evaluation', 'timeFrame': '6 months', 'description': 'Radiographical evaluation of bone density (BD) was performed immediately and after 6 months postoperatively of implant loading using CBCT'}, {'measure': 'clinical evaluation', 'timeFrame': '6 months', 'description': 'modified sulcus bleeding index (mSBI) were evaluated at 3 months and 6 months after loading'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immediate loading', 'Hyaluronic acid', 'Atorvastatin', '; Bone density; Posterior maxilla.'], 'conditions': ['In Recent Years, There Has Been a Rise in the Use of Immediate Loading Protocols', 'Dental Implant Stability']}, 'descriptionModule': {'briefSummary': 'Background: In recent years, there has been a rise in the use of immediate loading protocols; however, the complex anatomy of the posterior maxilla presents challenges. Currently, there is a lack of comparative studies assessing the effects of hyaluronic acid and atorvastatin gel on enhancing bone density in this region in conjunction with immediate loading. This study aimed to compare the effect of topical application of atorvastatin gel versus hyaluronic acid around immediately loaded dental implant that replacing missed maxillary posterior teeth.\n\nPatients and methods: twenty one patients were chosen from the Outpatient Clinic in the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University seeking implant placement. Patients were divided randomly and equally into three groups: group I (control group): 7 patients received implants without coating by any materials. Group II \\[Hyaluronic acid (HA) group\\]: 7 patients received implants coated with HA gel .Group III \\[atorvastatin (ATV) group\\]: 7 patients received implants coated with ATV gel. Clinical evaluation of implant stability was performed at the time of implant insertion and after 3 and 6 months postoperative. Also, peri-implant pocket depth (PPD) and modified sulcus bleeding index (mSBI) were evaluated. Radiographical evaluation of bone density (BD) was performed immediately and after 6 months postoperatively of implant loading using CBCT. All clinical and radiographic data were subjected to statistical analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\-\n\nInclusion criteria:\n\n* patients with one or more missing maxillary posterior teeth\n* age ranging from 18 to 45 years\n* patient's cooperation\n* motivation and good oral hygiene\n* adequate occlusion (proper interarch space).\n\nExclusion Criteria:\n\n* individuals with systemic or local diseases that are contraindicative of surgery or implant placement\n* pregnant individuals\n* individuals with any bone diseases that may impede bone healing\n* smokers\n* individuals who exhibit parafunctional habits like bruxism and clenching."}, 'identificationModule': {'nctId': 'NCT06976866', 'briefTitle': 'Effect of Topical Application of Atorvastatin Gel Versus Hyaluronic Acid on Immediate Loading Dental Implant in Posterior Maxilla', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Effect of Topical Application of Atorvastatin Gel Versus Hyaluronic Acid on Immediate Loading Dental Implant in Posterior Maxilla', 'orgStudyIdInfo': {'id': 'M0103023OS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hyaluronic acid', 'description': '\\[Hyaluronic acid (HA) group\\]: 7 patients received implants coated with HA gel .', 'interventionNames': ['Procedure: implant surgery']}, {'type': 'EXPERIMENTAL', 'label': 'atorvastatin', 'description': '\\[atorvastatin (ATV) group\\]: 7 patients received implants coated with ATV gel', 'interventionNames': ['Procedure: implant surgery']}, {'type': 'EXPERIMENTAL', 'label': 'control', 'description': 'group I (control group): 7 patients received implants without coating by any materials.', 'interventionNames': ['Procedure: implant surgery']}], 'interventions': [{'name': 'implant surgery', 'type': 'PROCEDURE', 'otherNames': ['hyaluronic acid around implant', 'atorvastatin around implant'], 'description': 'surgery', 'armGroupLabels': ['atorvastatin', 'control', 'hyaluronic acid']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Amira Attia', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amira attia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Amira attia', 'investigatorAffiliation': 'Mansoura University'}}}}