Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-03-03 @ 2:07 PM
Study NCT ID:
NCT03629860
Status:
UNKNOWN
Last Update Posted:
2018-08-14
First Post:
2018-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ascending Ramus Versus Chin Cortical Plates for Reconstruction of Atrophic Maxilla
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001284', 'term': 'Atrophy'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Assessment of ascending ramus cortical plate for reconstruction of atrophic maxillary ridges versus chin cortical plates (Randomized clinical trial)'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Assessment of ascending ramus cortical plate for reconstruction of atrophic maxillary ridges versus chin cortical plates (Randomized clinical trial)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2019-04-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-13', 'studyFirstSubmitDate': '2018-08-06', 'studyFirstSubmitQcDate': '2018-08-13', 'lastUpdatePostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'width and height of the bone gained by the procedure and the new measures from a physiologic vital structures e.g( nasal floor, maxillary sinus or even occlusal plan)', 'timeFrame': '6 months', 'description': 'new bone formation'}], 'secondaryOutcomes': [{'measure': 'Histomorphometric analysis bone area percent', 'timeFrame': '6 months', 'description': 'Nature and quality of new bone histology'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atrophic, augmetation, bone regeneration'], 'conditions': ['Atrophy of Edentulous Maxillary Alveolar Ridge']}, 'referencesModule': {'references': [{'pmid': '25183902', 'type': 'BACKGROUND', 'citation': 'Ali SA, Karthigeyan S, Deivanai M, Kumar A. Implant rehabilitation for atrophic maxilla: a review. J Indian Prosthodont Soc. 2014 Sep;14(3):196-207. doi: 10.1007/s13191-014-0360-4. Epub 2014 Apr 22.'}, {'pmid': '15800467', 'type': 'BACKGROUND', 'citation': 'Sorni M, Guarinos J, Garcia O, Penarrocha M. Implant rehabilitation of the atrophic upper jaw: a review of the literature since 1999. Med Oral Patol Oral Cir Bucal. 2005 Apr 1;10 Suppl 1:E45-56. English, Spanish.'}, {'pmid': '22117951', 'type': 'BACKGROUND', 'citation': 'Dym H, Huang D, Stern A. Alveolar bone grafting and reconstruction procedures prior to implant placement. Dent Clin North Am. 2012 Jan;56(1):209-18, x. doi: 10.1016/j.cden.2011.09.005.'}, {'pmid': '19418861', 'type': 'BACKGROUND', 'citation': 'Bellini CM, Romeo D, Galbusera F, Agliardi E, Pietrabissa R, Zampelis A, Francetti L. A finite element analysis of tilted versus nontilted implant configurations in the edentulous maxilla. Int J Prosthodont. 2009 Mar-Apr;22(2):155-7.'}, {'pmid': '23522364', 'type': 'BACKGROUND', 'citation': 'Bidra AS, Almas K. Mini implants for definitive prosthodontic treatment: a systematic review. J Prosthet Dent. 2013 Mar;109(3):156-64. doi: 10.1016/S0022-3913(13)60035-9.'}, {'pmid': '16104964', 'type': 'BACKGROUND', 'citation': 'Chiriac G, Herten M, Schwarz F, Rothamel D, Becker J. Autogenous bone chips: influence of a new piezoelectric device (Piezosurgery) on chip morphology, cell viability and differentiation. J Clin Periodontol. 2005 Sep;32(9):994-9. doi: 10.1111/j.1600-051X.2005.00809.x.'}, {'pmid': '7000788', 'type': 'BACKGROUND', 'citation': 'Enneking WF, Eady JL, Burchardt H. Autogenous cortical bone grafts in the reconstruction of segmental skeletal defects. J Bone Joint Surg Am. 1980 Oct;62(7):1039-58.'}, {'pmid': '22851285', 'type': 'BACKGROUND', 'citation': 'Menini M, Signori A, Tealdo T, Bevilacqua M, Pera F, Ravera G, Pera P. Tilted implants in the immediate loading rehabilitation of the maxilla: a systematic review. J Dent Res. 2012 Sep;91(9):821-7. doi: 10.1177/0022034512455802. Epub 2012 Jul 31.'}, {'pmid': '10453671', 'type': 'BACKGROUND', 'citation': 'Peleg M, Mazor Z, Garg AK. Augmentation grafting of the maxillary sinus and simultaneous implant placement in patients with 3 to 5 mm of residual alveolar bone height. Int J Oral Maxillofac Implants. 1999 Jul-Aug;14(4):549-56.'}, {'pmid': '20595216', 'type': 'BACKGROUND', 'citation': 'Topolovec-Vranic J, Canzian S, Innis J, Pollmann-Mudryj MA, McFarlan AW, Baker AJ. Patient satisfaction and documentation of pain assessments and management after implementing the adult nonverbal pain scale. Am J Crit Care. 2010 Jul;19(4):345-54; quiz 355. doi: 10.4037/ajcc2010247.'}]}, 'descriptionModule': {'briefSummary': 'Assessment of ascending ramus cortical plate for reconstruction of atrophic maxillary ridges versus chin cortical plates (Randomized clinical trial)', 'detailedDescription': 'Assessment of ascending ramus cortical plate for reconstruction of atrophic maxillary ridges versus chin cortical plates (Randomized clinical trial) To know what is better and more efficient chin or ascending ramus cortical plates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with atrophic maxilla with residual bone height from 3 to 4mm.\n* Both sexes\n\nExclusion Criteria:\n\n* Intraoral soft and hard tissue pathology.\n* Systemic condition that contraindicate implant basement.\n* Psychiatric problems'}, 'identificationModule': {'nctId': 'NCT03629860', 'briefTitle': 'Ascending Ramus Versus Chin Cortical Plates for Reconstruction of Atrophic Maxilla', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Assessment of Mandibular Ascending Ramus Cortical Plates for Reconstruction of Atrophic Maxillary Ridges Versus Chin Cortical Plates(Randomized Clinical Tial)', 'orgStudyIdInfo': {'id': 'Ahmed yousri'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ascending ramus group', 'description': '* Local anesthesia will be given to the patient\n* flap will be reflected to expose the facial wall of the maxilla then The ascending ramus is accessed.\n* A disc bur will be used to make a rectangular osteotomy\n* The block bone graft is removed from ascending ramus to recipient site the fixed by mini screws\n* Doner site flap is closed by using interrupted internal sutures.\n* after atrophic maxillary alveolar ridge augmentation,sub mucosal periosteal releasing cuts is done\n* Post-operative medications will be prescribed as follows: amoxicillin/clavulanic acid tablets 10mg/kg every 12 hours for 7 days, metronidazole 5 mg/kg every 8 hours for 7 days', 'interventionNames': ['Procedure: Atrophic maxillary alveolar ridge augmentation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chin Group', 'description': '* Local anesthesia will be given to the patient\n* flap will be reflected to expose the facial wall of the maxilla then The chin is accessed.\n* A disc bur will be used to make a rectangular osteotomy\n* The block bone graft is removed from chin to recipient site the fixed by mini screws\n* Doner site flap is closed by using interrupted internal sutures\n* after atrophic maxillary alveolar ridge augmentation,submucosal periosteal releasing cuts is done\n* Post-operative medications will be prescribed as follows: amoxicillin/clavulanic acid tablets 10mg/kg every 12 hours for 7 days, metronidazole 5 mg/kg every 8 hours for 7days', 'interventionNames': ['Procedure: Atrophic maxillary alveolar ridge augmentation']}], 'interventions': [{'name': 'Atrophic maxillary alveolar ridge augmentation', 'type': 'PROCEDURE', 'description': 'Autogenous bone blocks from chin and ascending ramus are obtained and used for reconstruction of atrophic maxillary ridges', 'armGroupLabels': ['Chin Group', 'ascending ramus group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11553', 'city': 'Cairo', 'state': 'Al-Manial', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed Y Zayed, BSD', 'role': 'CONTACT', 'email': 'ahmed.zayed@dentistry.cu.edu.eg', 'phone': '01111634311'}, {'name': 'Ahmed Y Usry, BSD', 'role': 'CONTACT', 'email': 'ahmed.zayed.implantology@gmail.com', 'phone': '01140425144'}], 'facility': 'Faculty of Dentistry, Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Ahmed Y Zayed, BSD', 'role': 'CONTACT', 'email': 'ahmed.zayed@dentistry.cu.edu.eg', 'phone': '00201111634311', 'phoneExt': '00201140425144'}, {'name': 'Ahmed Y Usry, BSD', 'role': 'CONTACT', 'email': 'ahmed.zayed.imlantology@gmail.com', 'phone': '00201140425144', 'phoneExt': '00201140425144'}], 'overallOfficials': [{'name': 'Ahmed Y Yousri, Bsd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Websites and papers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'B.D.S,Principal investigator,dentist', 'investigatorFullName': 'ahmed yousri said zayed', 'investigatorAffiliation': 'Cairo University'}}}}