Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT06395818
Status:
COMPLETED
Last Update Posted:
2024-12-11
First Post:
2024-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
the Effect of Hyaluronic Acid on a Prefabricated CAD-CAM Bone Blocks for Ridge Augmentation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'using closed envelop for participants the data will be given to outcomes assessors without defining the intervention for each group'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'parallel assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-06', 'studyFirstSubmitDate': '2024-04-29', 'studyFirstSubmitQcDate': '2024-04-29', 'lastUpdatePostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'measurement the width and the height of the alveolar ridge', 'timeFrame': '6 months', 'description': 'using CBCT the width and the height will be measured with measuring tools in milimeter (mm)'}, {'measure': 'the amount of new bone formation', 'timeFrame': '6 months', 'description': 'core biopsy will be underwent histomorphometric analysis to determine the percentage of new bone formation (%)'}], 'secondaryOutcomes': [{'measure': 'the sucess of dental implants', 'timeFrame': '12 months', 'description': 'usingCBCT to determine the amount of marginal bone loss in (mm)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CAD-CAM bone blocks', 'hyaluronic acid', 'histomorphometric analysis'], 'conditions': ['Atrophy of Edentulous Alveolar Ridge']}, 'referencesModule': {'references': [{'pmid': '40231349', 'type': 'DERIVED', 'citation': 'Helal MH, Sheta MS, Alsherif AA, Hassan MA, Aboushelib MN, Ghouraba RF. The Effectiveness of Hyaluronic Acid on Prefabricated CAD CAM Bone Blocks for Ridge Augmentation: A Split Mouth Study. Clin Implant Dent Relat Res. 2025 Apr;27(2):e70035. doi: 10.1111/cid.70035.'}]}, 'descriptionModule': {'briefSummary': 'Each patient will receive 2 prefabricated CAD-CAM allogeneic bone blocks sterilized with gamma rays with different rehydration methods.\n\nSide I: prefabricated CAD-CAM allogeneic bone block sterilized with gamma rays hydrated using hyaluronic acid \\* Side II: prefabricated CAD-CAM allogeneic bone block sterilized with gamma rays hydrated using saline solution Both blocks are fixed with osteosynthesis screws, covered with non resorbable membranes\\*\\* The membranes will be removed after 6 months, dental implants will be placed and core biopsy will be collected from the site of the implant placement for histologic evaluation', 'detailedDescription': '10 patients will be included in this study with bilateral atrophic posterior mandible for split mouth research\n\n. group I: prefabricated CAD-CAM allogeneic bone block sterilized with gamma rays hydrated using hyaluronic acid group II: prefabricated CAD-CAM allogeneic bone block sterilized with gamma rays hydrated using saline solution under LA mucoperiosteal flap will be elevated to expose the atrophic ridge then the prefabricated CAD-CAM allogenic block either mixed with hyaluronic acid (group I) or saline (group II) will be fixed in its position with titanium miniscrews , The block was coated with a nonporous d-PTFE membrane then closure of flap with nylon second stage: 6 months later exposure of alveolar ridge core biopsy was taken for histological study then insertion of titanium implants.\n\nthe aim of the study is to investigate the effect of hyaluronic acid on a prefabricated CAD- CAM bone blocks for ridge augmentation radiographically and histologically.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patients between 40 to 65 years old.\n* Posterior atrophic mandibular ridge indicated for horizontal and vertical ridge augmentation for dental implant placement.\n* Good oral hygiene\n\nExclusion Criteria:\n\n* Systemic diseases that affect host healing responses.\n* Heavy smoking.\n* Poor oral hygiene.\n* Traumatic occlusion, sever para-functional habits (ex. bruxism, clenching,)'}, 'identificationModule': {'nctId': 'NCT06395818', 'briefTitle': 'the Effect of Hyaluronic Acid on a Prefabricated CAD-CAM Bone Blocks for Ridge Augmentation', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'The Effectiveness of Hyaluronic Acid on Prefabricated CAD CAM Bone Blocks for Ridge Augmentation: A Split Mouth Study', 'orgStudyIdInfo': {'id': '6789'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'prefabricated CAD-CAM allogeneic bone block hydrated using hyaluronic acid', 'description': 'mucoperiosteal flap will be elevated to expose the atrophic ridge then the prefabricated CAD-CAM allogenic block will be fixed in its position with titanium miniscrews , The block was coated with a nonporous d-PTFE membrane', 'interventionNames': ['Procedure: prefabricated CAD-CAM allogeneic bone block hydrated using hyaluronic acid']}, {'type': 'EXPERIMENTAL', 'label': 'prefabricated CAD-CAM allogeneic bone block sterilized hydrated using saline solution', 'description': 'mucoperiosteal flap will be elevated to expose the atrophic ridge then the prefabricated CAD-CAM allogenic block will be fixed in its position with titanium miniscrews ,The block was coated with a nonporous d-PTFE membrane', 'interventionNames': ['Procedure: prefabricated CAD-CAM allogeneic bone block sterilized hydrated using saline solution']}], 'interventions': [{'name': 'prefabricated CAD-CAM allogeneic bone block hydrated using hyaluronic acid', 'type': 'PROCEDURE', 'description': 'exposure of atrophic posterior mandibular ridge, augmentation with CAD-CAM prefabricated allogenic bone block which fixed with titanium screws ,The block was coated with a nonporous d-PTFE membrane', 'armGroupLabels': ['prefabricated CAD-CAM allogeneic bone block hydrated using hyaluronic acid']}, {'name': 'prefabricated CAD-CAM allogeneic bone block sterilized hydrated using saline solution', 'type': 'PROCEDURE', 'description': 'exposure of atrophic posterior mandibular ridge, augmentation with CAD-CAM prefabricated allogenic bone block which fixed with titanium screws. The block was coated with a nonporous d-PTFE membrane', 'armGroupLabels': ['prefabricated CAD-CAM allogeneic bone block sterilized hydrated using saline solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3111', 'city': 'Tanta', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'overallOfficials': [{'name': 'mohamed h helal, lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tanta University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of oral medicine, periodontology, oral diagnosis and radiology department', 'investigatorFullName': 'Mohamed Hamdy Helal', 'investigatorAffiliation': 'Tanta University'}}}}