Ignite Creation Date:
2025-12-26 @ 2:38 PM
Ignite Modification Date:
2026-03-03 @ 2:17 PM
Study NCT ID:
NCT03607006
Status:
COMPLETED
Last Update Posted:
2024-04-09
First Post:
2018-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ridge Augmentation Using Patient Specific PEEK Sheets vs. Autogenous Bone Shell Technique.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': "None because the two interventions requires different preoperative preparations , both the participants and the investigator can't be blinded ."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '* A randomized clinical trial.\n* Parallel group study.\n* A trial will be carried out in hospital of Oral and Maxillofacial surgery department - Faculty of Oral and Dental Medicine - Cairo University .\n* Equal randomization : participants with equal probabilities for intervention.\n* Positive controlled : Both groups receiving treatment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-06', 'studyFirstSubmitDate': '2018-07-23', 'studyFirstSubmitQcDate': '2018-07-29', 'lastUpdatePostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': '8 months', 'description': 'Questionnaire will be used to evaluate the satisfaction , measuring unit Binary (YES/NO)'}], 'secondaryOutcomes': [{'measure': 'Bone gain', 'timeFrame': '4-6 months post-operative', 'description': 'Bone gain will be evaluated using the Computed tomography , measuring unit (mm)'}, {'measure': 'Bone quality', 'timeFrame': '4-6 months post-operative', 'description': 'Histological analysis of bone core biopsy , measuring unit Osteon number'}, {'measure': 'Soft tissue reaction', 'timeFrame': '4-6 months postoperative', 'description': 'Clinical evaluation by caliber to measure thickness of keratinized mucosa ,measuring unit (mm)'}, {'measure': 'Intraoperative time', 'timeFrame': 'Intraoperative', 'description': 'Using stop watch to measure the operative time'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anterior maxillary region', 'Patient specific', 'Autogenous bone shell', 'PEEK', 'Ridge augmentation'], 'conditions': ['Ridge Deficiency']}, 'referencesModule': {'references': [{'pmid': '33231752', 'type': 'DERIVED', 'citation': 'Mounir M, Morsy OAE, Amer H, Mounir S, Gibaly A. Assessment of bone quality using buccal and palatal autogenous cortical shells harvested from two different mandibular donor sites for maxillary alveolar ridge augmentation: a histomorphometric randomized clinical trial. Oral Maxillofac Surg. 2021 Jun;25(2):263-269. doi: 10.1007/s10006-020-00924-w. Epub 2020 Nov 24.'}]}, 'descriptionModule': {'briefSummary': 'Comparative study to assess the ability of the patient specific PEEK sheets in ridge augmentation with using mixed Autogenous/Xenogenic bone graft vs the Bone Shell Technique regarding the time, accuracy and donor site morbidity .', 'detailedDescription': 'A- Intervention Group (Patient specific PEEK sheets)\n\n* Preoperative Computed tomography will be done to the patients.\n* Using special software, 3D models will be obtained and used to design the custom made PEEK sheets. The final STL (Standard Tessellation Language) files will be sent to the lab to be milled/printed.\n* Autogenous bone graft will be taken from Chin/Retromolar graft and will be mixed with xenogenic bone graft in 1:1 ratio.\n* After bone exposure, the ridge will be decorticated and the prefabricated PEEK sheets will be fixed with titanium screws and the space between the sheets and the ridge will be filled with the prepared bone graft.\n* Wounds closure will be done.\n* CT scan will be done postoperative.\n* After 6 months another CT scan will be done for evaluation and comparison. Then the titanium screws will be removed and implants will be placed.\n\nB- Control Group (Autogenous bone shell technique)\n\n* Preoperative Computed tomography will be done to the patients\n* Bone graft will be harvested from the chin/retromolar region and a cortico- cancellous bone block will be obtained then divided into two pieces used as the shells.\n* The bone shells will be trimmed and adjusted to the recipient site and the remaining bone will be milled and mixed with Xenogenic bone graft with ratio 1:1\n* The bone shells will be anchored in the host bone with titanium screws and the space between the shells and the alveolar bone will be filled by the bone graft mix.\n* Wounds closure will be done.\n* CT scan will be done.\n* After 6 months another CT scan will be done for evaluation and comparison. Then the patient will go for micro screws removal along with implant placement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with deficient alveolar bone in the anterior maxilla.\n* Patient seeking fixed prosthesis at the anterior maxillary region.\n* Highly motivated patients.\n* Good oral hygiene.\n* Patients willing for the surgical procedure and follow-up, with an informed consent.\n* Bounded anterior maxilla cases.\n\nExclusion Criteria:\n\n* Medically compromised patients.\n* Uncooperative patients.\n* Poor oral hygiene.\n* Periodontal diseases.\n* No history of any grafting procedure at the designated edentulous ridge.Criteria\n* Patients with any diseases that compromise bone or soft tissue healing.\n* Patients with no local pathosis that interfere with the bone healing.'}, 'identificationModule': {'nctId': 'NCT03607006', 'briefTitle': 'Ridge Augmentation Using Patient Specific PEEK Sheets vs. Autogenous Bone Shell Technique.', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': '3D Ridge Augmentation in the Anterior Maxillary Region Using Patient Specific Polyether Ether Ketone (PEEK) Sheets vs. Autogenous Bone Shell Technique. A Randomized Clinical Trial: Comparative Study', 'orgStudyIdInfo': {'id': 'CEBD-CU-2018-07-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient specific PEEK sheets', 'description': 'Patient specific PEEK sheets will be fixed with titanium screws and act as containment system for the mixed autogenous/xenogenic bone graft that will fill the gap between the sheets and the ridge .', 'interventionNames': ['Procedure: Patient specific PEEK sheets']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Autogenous bone shell technique', 'description': 'Bone shells will be fixed with titanium screws to the ridge and mixed autogenous/xenogenic bone graft will fill the gap between the shells and the ridge .', 'interventionNames': ['Procedure: Autogenous bone shell']}], 'interventions': [{'name': 'Patient specific PEEK sheets', 'type': 'PROCEDURE', 'description': 'Computer aided sheet design', 'armGroupLabels': ['Patient specific PEEK sheets']}, {'name': 'Autogenous bone shell', 'type': 'PROCEDURE', 'description': 'autogenous retromolar/chin bone graft', 'armGroupLabels': ['Autogenous bone shell technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12613', 'city': 'Giza', 'country': 'Egypt', 'facility': 'Faculty of Oral and Dental Medicine - Cairo University', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'Ahmed A Brakart, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}, {'name': 'Mohamed M Shaker, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ola Alaa El-Din Abd El-Monem Mohamed', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cairo University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Ola Alaa El-Din Abd El-Monem Mohamed', 'investigatorAffiliation': 'Cairo University'}}}}