Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2026-01-11 @ 10:34 AM
Study NCT ID:
NCT06468592
Status:
COMPLETED
Last Update Posted:
2024-06-21
First Post:
2024-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implantation in Posterior Maxilla in Cases With Insufficient Bone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-20', 'studyFirstSubmitDate': '2024-06-15', 'studyFirstSubmitQcDate': '2024-06-20', 'lastUpdatePostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The initial implant stability', 'timeFrame': 'one time assessment at five minutes following the completion of inserting implants.', 'description': 'Primary stability was recorded for all implants in both groups, estimated by Newton/cm (N/cm), using a manual torque wrench.\n\nThis manual measure consists of a fixed arm installed above the implants and a moving arm moving away from the fixed arm in a clockwise direction, graduating from 5-45 Newtons. When the moving arm stops, the distance between it and the fixed arm expresses the first degree of the initial primary stability.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bone Loss in Jaw', 'Implant Site Reaction']}, 'referencesModule': {'references': [{'pmid': '8055514', 'type': 'BACKGROUND', 'citation': 'Summers RB. The osteotome technique: Part 2--The ridge expansion osteotomy (REO) procedure. Compendium. 1994 Apr;15(4):422, 424, 426, passim; quiz 436.'}, {'pmid': '7994726', 'type': 'BACKGROUND', 'citation': 'Summers RB. The osteotome technique: Part 3--Less invasive methods of elevating the sinus floor. Compendium. 1994 Jun;15(6):698, 700, 702-4 passim; quiz 710.'}, {'pmid': '8598008', 'type': 'BACKGROUND', 'citation': 'Summers RB. The osteotome technique: Part 4--Future site development. Compend Contin Educ Dent. 1995 Nov;16(11):1090, 1092 passim; 1094-1096, 1098, quiz 1099.'}, {'pmid': '10146541', 'type': 'BACKGROUND', 'citation': 'Boyne PJ. Analysis of performance of root-form endosseous implants placed in the maxillary sinus. J Long Term Eff Med Implants. 1993;3(2):143-59.'}, {'pmid': '24977252', 'type': 'BACKGROUND', 'citation': 'Del Fabbro M, Ceresoli V. The fate of marginal bone around axial vs. tilted implants: a systematic review. Eur J Oral Implantol. 2014 Summer;7 Suppl 2:S171-89.'}, {'pmid': '25853626', 'type': 'BACKGROUND', 'citation': 'Barnea E, Tal H, Nissan J, Tarrasch R, Peleg M, Kolerman R. The Use of Tilted Implant for Posterior Atrophic Maxilla. Clin Implant Dent Relat Res. 2016 Aug;18(4):788-800. doi: 10.1111/cid.12342. Epub 2015 Apr 8.'}, {'pmid': '23627307', 'type': 'BACKGROUND', 'citation': 'Malo P, de Araujo Nobre M. Partial rehabilitation of the posterior edentulous maxilla using axial and tilted implants in immediate function to avoid bone grafting. Compend Contin Educ Dent. 2011 Nov-Dec;32(9):E136-45.'}, {'pmid': '22121829', 'type': 'BACKGROUND', 'citation': 'Penarrocha-Oltra D, Candel-Marti E, Ata-Ali J, Penarrocha-Diago M. Rehabilitation of the atrophic maxilla with tilted implants: review of the literature. J Oral Implantol. 2013 Oct;39(5):625-32. doi: 10.1563/AAID-JOI-D-11-00068. Epub 2011 Nov 28.'}, {'pmid': '31449578', 'type': 'BACKGROUND', 'citation': "Bruschi E, Manicone PF, De Angelis P, Papetti L, Pastorino R, D'Addona A. Comparison of Marginal Bone Loss Around Axial and Tilted Implants: A Retrospective CBCT Analysis of Up to 24 Months. Int J Periodontics Restorative Dent. 2019 Sep/Oct;39(5):675-684. doi: 10.11607/prd.4110."}]}, 'descriptionModule': {'briefSummary': 'Dental implant procedures are performed on two groups of individuals who share the common characteristic of insufficient bone for traditional implantation.\n\nThe first group lacks a palatal process, while the second group has a palatal process. Then, compare the initial primary stability of implants in the maxillary bone-type (D4) that were inserted tilted in the palatal process of the maxilla, palatally from the maxillary sinus, with implants inserted axially into the maxillary sinus by using a manual torque wrench.', 'detailedDescription': 'Increasing the initial primary stability intensity value increases the success rate of implants in general and also allows immediate or early loading procedures to begin. In addition, to avoid complications resulting from inserting implants into the compromised maxillary sinus according to the Summers method. The most important of these is perforation of the mucous membrane lining the maxillary sinus and the possibility of its application in pathological cases of the maxillary sinus, such as chronic maxillary sinusitis and the presence of mucous retention cysts, in which intervention according to the usual Summers method is not indicated.\n\nDespite the previous advantages obtained by this method, there are some disadvantages to the technique of tilting the implants in the palatal direction from the maxillary sinus, which are the limitation of its application to cases with a palatal process of the maxilla in the upper jawbone, which requires performing a three-dimensional radiograph. It was observed in this study and after studying the cross-sections that sufficient thickness for this process was less likely present than in cases of its absence. In addition, prosthetic procedures are generally difficult in tilted implants compared to axial implants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '73 Years', 'minimumAge': '32 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria for both groups:\n\n* Patients must have inadequate bone density in the posterior region of the upper jaw.\n* Patients should maintain good oral hygiene.\n* The surgical site must be free from infection.\n* There should be no contraindications for oral surgery.\n\nFor the first group:\n\n\\- Patients in the first group must have a palatal process of the maxillary bone determined by radiographic examination.\n\nExclusion criteria:\n\n* Patients with adequate bone volume to receive an implant.\n* Patients with systemic diseases that impair metabolism or healing at the surgical site.\n* Patients with contraindications for surgery, including cardiovascular disorders, blood clotting disorders, anticoagulant use, or uncontrolled diabetes.\n* Patients receiving medications that affect bone metabolism, such as corticosteroids, oral contraceptives, hormonal treatments, or those undergoing chemical or radiological therapies.'}, 'identificationModule': {'nctId': 'NCT06468592', 'briefTitle': 'Implantation in Posterior Maxilla in Cases With Insufficient Bone', 'organization': {'class': 'OTHER', 'fullName': 'Damascus University'}, 'officialTitle': 'Implantation in the Palatal Process of the Maxilla as a Modification of the Osteotome Sinus Floor Elevation (Summers Technique)', 'orgStudyIdInfo': {'id': 'UDDS-OMFS-1-2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tilted implants', 'description': 'The tilted implants are inserted palatally into the maxillary sinus', 'interventionNames': ['Procedure: Tilted insertion of implants']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Straight implants', 'description': 'The implants inserted into the maxillary sinus in an axial direction', 'interventionNames': ['Procedure: Straight insertion of implants']}], 'interventions': [{'name': 'Tilted insertion of implants', 'type': 'PROCEDURE', 'description': 'Using osteotomes, implants are inserted and tilted from 30° to 45° into the palatal direction from the maxillary sinus.', 'armGroupLabels': ['Tilted implants']}, {'name': 'Straight insertion of implants', 'type': 'PROCEDURE', 'description': "The implants are inserted in an axial direction into the maxillary sinus according to Summers' traditional technique.", 'armGroupLabels': ['Straight implants']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aleppo', 'country': 'Syria', 'facility': 'Orthodontics Department, Faculty of Dentistry, University of Aleppo', 'geoPoint': {'lat': 36.20124, 'lon': 37.16117}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Damascus University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}