Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2025-12-29 @ 1:23 PM
Study NCT ID:
NCT06195761
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-27
First Post:
2023-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Computer Guided Modified Ridge Splitting Versus Free Hand Technique in Horizontal Deficiency in Posterior Mandible
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']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'treatment plan includes harvesting and fixing the bone graft in posterior mandibular area using a computer-modified surgical guide'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-25', 'studyFirstSubmitDate': '2023-12-23', 'studyFirstSubmitQcDate': '2023-12-23', 'lastUpdatePostDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of the Computer Assessed Guide in the study group', 'timeFrame': 'immediately postoperative', 'description': 'Accuracy of the Computer Assessed Guide in the study group In comparison with the control group between predicted and immediately postoperative horizontal bone width with Cone beam computed tomography in Millimeters'}], 'secondaryOutcomes': [{'measure': 'Alveolar ridge horizontal bone gain', 'timeFrame': '4 months', 'description': 'measure the amount of horizontal bone width gaining by postoperative cone beam computed tomography in millimeters'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['computer guided modified ridge splitting', 'computer guided modified cortical shell technique', 'guided modified ridge splitting in posterior mandible'], 'conditions': ['Horizontal Bone Augmentation', 'Horizontal Ridge Deficiency']}, 'referencesModule': {'references': [{'pmid': '22233422', 'type': 'RESULT', 'citation': 'Al-Ani O, Nambiar P, Ha KO, Ngeow WC. Safe zone for bone harvesting from the interforaminal region of the mandible. Clin Oral Implants Res. 2013 Aug;24 Suppl A100:115-21. doi: 10.1111/j.1600-0501.2011.02393.x. Epub 2012 Jan 11.'}, {'pmid': '33161168', 'type': 'RESULT', 'citation': 'Sanchez-Labrador L, Molinero-Mourelle P, Perez-Gonzalez F, Saez-Alcaide LM, Brinkmann JC, Martinez JL, Martinez-Gonzalez JM. Clinical performance of alveolar ridge augmentation with xenogeneic bone block grafts versus autogenous bone block grafts. A systematic review. J Stomatol Oral Maxillofac Surg. 2021 Jun;122(3):293-302. doi: 10.1016/j.jormas.2020.10.009. Epub 2020 Nov 5.'}, {'pmid': '27977816', 'type': 'RESULT', 'citation': 'De Stavola L, Fincato A, Bressan E, Gobbato L. Results of Computer-Guided Bone Block Harvesting from the Mandible: A Case Series. Int J Periodontics Restorative Dent. 2017 Jan/Feb;37(1):e111-e119. doi: 10.11607/prd.2721.'}, {'pmid': '15968184', 'type': 'RESULT', 'citation': 'Schwartz-Arad D, Levin L, Sigal L. Surgical success of intraoral autogenous block onlay bone grafting for alveolar ridge augmentation. Implant Dent. 2005 Jun;14(2):131-8. doi: 10.1097/01.id.0000165031.33190.0d.'}, {'pmid': '25851960', 'type': 'RESULT', 'citation': 'Assaf A, Saad M, Daas M, Abdallah J, Abdallah R. Use of narrow-diameter implants in the posterior jaw: a systematic review. Implant Dent. 2015 Jun;24(3):294-306. doi: 10.1097/ID.0000000000000238.'}]}, 'descriptionModule': {'briefSummary': 'To assess the accuracy of the computer assessed guides in horizontal bone augmentation achieved at posterior mandible using guided modified ridge splitting technique versus free hand modified ridge splitting technique', 'detailedDescription': 'The first treatment plan includes harvesting and fixing the bone graft in posterior mandibular area using a computer-modified surgical guide.\n\nThe second treatment plan includes manually harvesting and fixing the bone graft in posterior mandibular area without a surgical guide.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* posterior mandible with horizontal deficient alveolar ridge that is from 2 to 4 mm measured from the crest of the alveolar ridge buccolingually\n* Age range from 25-55 years. No sex predilection.\n* Patients free from any systemic conditions and bone metabolism diseases that might interfere with the surgical intervention, soft tissue or hard tissue healing.\n* Patients of adequate alveolar bone width.\n* Both genders males and females will be included\n* Normal vertical dimension with normal inter-arch space. The minimum number of missing teeth in the posterior mandible alveolar ridge is two adjacent anterior teeth\n\nExclusion Criteria:\n\n* Intra-bony lesions (e.g. cysts) or infections (e.g. abscess) that may retard the osteotomy healing.\n* Previous grafting procedures in the edentulous area.\n* General contraindications to implant surgery.\n* Subjected to irradiation in the head and neck area less than 1 year before implantation.\n* Untreated periodontitis.\n* Poor oral hygiene and motivation.\n* Uncontrolled diabetes.\n* Pregnant or nursing.\n* Immunosuppressed or immunocompromised\n* Heavy smokers\n* Patients undergo medication interfere with bone healing'}, 'identificationModule': {'nctId': 'NCT06195761', 'briefTitle': 'Computer Guided Modified Ridge Splitting Versus Free Hand Technique in Horizontal Deficiency in Posterior Mandible', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Radiographic Assessment of Computer Guided Modified Ridge Splitting Technique Versus Conventional Free Hand Technique in Management of Horizontal Deficiency in Posterior Mandible: a Randomized Control Clinical Trial', 'orgStudyIdInfo': {'id': 'computer guided modified ridge'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'computer guided modified ridge splitting technique (study group)', 'description': 'The first treatment plan includes harvesting and fixing the bone graft in posterior mandibular area using a computer-modified surgical guide.', 'interventionNames': ['Procedure: computer guided modified ridge splitting technique in horizontal bone deficiency in posterior mandible']}, {'type': 'EXPERIMENTAL', 'label': 'conventional modified ridge splitting technique (control group)', 'description': 'The second treatment plan includes manually harvesting and fixing the bone graft in posterior mandibular area without a surgical guide', 'interventionNames': ['Procedure: free hand modified ridge splitting technique in horizontal bone deficiency in posterior mandible']}], 'interventions': [{'name': 'computer guided modified ridge splitting technique in horizontal bone deficiency in posterior mandible', 'type': 'PROCEDURE', 'otherNames': ['computer guided modified cortical shell technique'], 'description': 'treatment plan includes harvesting and fixing the bone graft in posterior mandibular area using a computer-modified surgical guide', 'armGroupLabels': ['computer guided modified ridge splitting technique (study group)']}, {'name': 'free hand modified ridge splitting technique in horizontal bone deficiency in posterior mandible', 'type': 'PROCEDURE', 'otherNames': ['conventional modified cortical shell technique'], 'description': 'treatment plan includes manually harvesting and fixing the bone graft in posterior mandibular area without a surgical guide.', 'armGroupLabels': ['conventional modified ridge splitting technique (control group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12613', 'city': 'Cairo', 'state': 'Manial', 'country': 'Egypt', 'facility': 'Faculty of Dentistry - Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mina ElHadidi Sobhi Ramzi, BDS', 'role': 'CONTACT', 'email': 'mina.ramzi@dentistry.cu.edu.eg', 'phone': '+201225339712'}], 'overallOfficials': [{'name': 'Mohamed Mounir Shaker, BDS,MSc,PHD', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo University'}, {'name': 'Rofaida Atef Abaas, BDS,MSc,PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mina ElHadidi Sobhi Ramzi Michael', 'investigatorAffiliation': 'Cairo University'}}}}