Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-01-03 @ 1:11 PM
Study NCT ID:
NCT04192851
Status:
COMPLETED
Last Update Posted:
2020-07-28
First Post:
2019-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of "Tent-Pole" Grafting Technique for Reconstruction of Mandibular Ridge Vertical Defects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007569', 'term': 'Jaw Abnormalities'}], 'ancestors': [{'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D019767', 'term': 'Maxillofacial Abnormalities'}, {'id': 'D019465', 'term': 'Craniofacial Abnormalities'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a single-arm trial of 12 patients with mandibular large vertical defects treated using synthetic bone graft around titanium screws to tent out the soft tissue matrix.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-25', 'studyFirstSubmitDate': '2019-12-07', 'studyFirstSubmitQcDate': '2019-12-07', 'lastUpdatePostDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain assessment using Visual Analogue Scale', 'timeFrame': '2 weeks', 'description': 'Pain was assessed through on a 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)'}, {'measure': 'Postoperative edema', 'timeFrame': '2 weeks', 'description': 'Edema was evaluated by its ability to pit.The examiner fingers pressed into dependent area of the patient skin for 5 seconds. The finger sinks into the tissue and leave an impression when they are removed. The pitting was graded on a scale of +1 to +4 as follows:\n\n* 1 (trace) slight indentation rapid return to normal.\n* 2 (mild) the indentation returns to normal in a few seconds.\n* 3 (moderate) 6 mm indentation rebounds in 10-20 seconds.\n* 4 (severe) 8 mm indentation rebounds in more than 30 seconds.'}, {'measure': 'Radiographic Evaluation for Bone Density using Cone Beam CT', 'timeFrame': '6 months', 'description': 'A Cone Beam Computerized Tomography was obtained to assess the gained bone height \\&density.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Jaw Deformity']}, 'referencesModule': {'references': [{'pmid': '19885447', 'type': 'BACKGROUND', 'citation': 'Jensen SS, Terheyden H. Bone augmentation procedures in localized defects in the alveolar ridge: clinical results with different bone grafts and bone-substitute materials. Int J Oral Maxillofac Implants. 2009;24 Suppl:218-36.'}, {'pmid': '19885448', 'type': 'BACKGROUND', 'citation': 'Chiapasco M, Casentini P, Zaniboni M. Bone augmentation procedures in implant dentistry. Int J Oral Maxillofac Implants. 2009;24 Suppl:237-59.'}, {'pmid': '18437791', 'type': 'BACKGROUND', 'citation': 'Aghaloo TL, Moy PK. Which hard tissue augmentation techniques are the most successful in furnishing bony support for implant placement? Int J Oral Maxillofac Implants. 2007;22 Suppl:49-70.'}, {'pmid': '18332757', 'type': 'BACKGROUND', 'citation': 'Le B, Burstein J, Sedghizadeh PP. Cortical tenting grafting technique in the severely atrophic alveolar ridge for implant site preparation. Implant Dent. 2008 Mar;17(1):40-50. doi: 10.1097/ID.0b013e318166d503.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate clinically and radio-graphically the efficiency of "Tent- Pole "grafting technique for reconstruction of anterior or posterior mandibular ridge defects using synthetic bone graft and Platelet Rich Fibrin (PRF) membrane.', 'detailedDescription': 'Various techniques have been described for the reconstruction of large vertical defects before implant placement . In this study we assessed the efficacy of tenting the periosteum and soft tissue matrix with titanium screws maintaining a space for the graft material in order to augment large vertical defects of mandibular ridge (anterior or posterior region) using data from 12 patients . After 6 months we assessed the increase in bone height and density.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with missing lower tooth or teeth and have a related large vertical bony defect .\n* Patients with about 7mm residual bone hight and requiring about 5 mm increase in the vertical height of the mandibular alveolar ridge for future prosthetic rehabilitation.\n* Patients with an acceptable oral hygiene and willing to improve it\n\nExclusion Criteria:\n\n* Presence of infection or local lesions.\n* Parafunctional habits.\n* Current chemotherapy or radiotherapy.\n* Heavy smokers.\n* Alcohol or drug abuse.\n* Medically compromised patients with diseases that affect passively the clinical procedure or result.'}, 'identificationModule': {'nctId': 'NCT04192851', 'briefTitle': 'Evaluation of "Tent-Pole" Grafting Technique for Reconstruction of Mandibular Ridge Vertical Defects', 'organization': {'class': 'OTHER', 'fullName': 'University of Alexandria'}, 'officialTitle': 'Evaluation of "Tent-Pole" Grafting Technique for Reconstruction of Mandibular Ridge Vertical Defects (Clinical and Radiographic Study)', 'orgStudyIdInfo': {'id': 'Tent-pole graft'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tent Pole Grafting Technique', 'description': '* Bone graft \\[NanoBone® granulate 0,6 mm (24% Silica / 76% Hydroxylapatite)\\] is mixed with the patient blood and placed to cover the screws completely, the defect is overcorrected with particulate material in anticipation of future graft resorption.\n* PRF membrane is prepared by:\n\nTen milliliters of whole venous blood will be collected in sterile glass test tubes without anticoagulant. Then the test tubes will be placed in a table centrifuge machine at 3000 revolutions per minute (rpm) for 10 minutes.After separation of PRF, the membrane is prepared compression device.', 'interventionNames': ['Procedure: Tent Pole Technique']}], 'interventions': [{'name': 'Tent Pole Technique', 'type': 'PROCEDURE', 'description': '* All patients were operated under local or general anaesthesia according to the case and patient tolerability.\n* The oral cavity was prepared by 0.12% chlorhexidine mouthrinses solution\\* for thirty seconds.\n* Full thickness incision down to the bone with blade no.15.\n* A periosteal elevator was used to perform mucoperiosteal flap.\n* Gentle elevation of the flap\n* Fixation of the screws over the alveolar ridge with about 5 mm of the screw threads will be exposed\n* Bone graft was mixed with the patient blood and placed to cover the screws completely.\n* PRF membrane was be placed over the grafted sites.\n* Repositioning of the flap and suturing with 3/0 black silk suture material', 'armGroupLabels': ['Tent Pole Grafting Technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21512', 'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Alexandria University', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Asmaa M Abd ElFattah, BDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Dentistry, Alexandria University, Egypt'}, {'name': 'Abd El Aziz F Khalil, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculty of Dentistry, Alexandria University, Egypt'}, {'name': 'Lydia N.F Melek, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Dentistry, Alexandria University, Egypt'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nourhan M.Aly', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alexandria University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Instructor of Dental Public Health', 'investigatorFullName': 'Nourhan M.Aly', 'investigatorAffiliation': 'University of Alexandria'}}}}