Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-01-02 @ 8:53 AM
Study NCT ID:
NCT06130657
Status:
COMPLETED
Last Update Posted:
2023-11-14
First Post:
2023-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Volumetric Analysis of Maxillary Sinus After Guided Lateral Sinus Lift Procedure
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', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-09', 'studyFirstSubmitDate': '2023-11-09', 'studyFirstSubmitQcDate': '2023-11-09', 'lastUpdatePostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maxillary sinus volume', 'timeFrame': 'Preoperative, Immediate postoperative, 6 Months', 'description': 'In cubic centimetre (cm3)'}], 'secondaryOutcomes': [{'measure': 'Bone Gain', 'timeFrame': 'Immediate postoperative, 6 Months', 'description': 'Im Millimeter (mm)'}, {'measure': 'Implant stability', 'timeFrame': 'Intra-operative, 6 Months', 'description': 'In implant stability quotient (ISQ)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sinus lifting', 'Dental implant'], 'conditions': ['Lateral Sinus Lifting', 'Dental Implant']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to present a guided lateral window sinus lift (GLSL) procedure with the aid of a fully digital workflow using surgical templates for window osteotomy preparation and implant placement.', 'detailedDescription': 'In Group 1; The surgical procedure began with the adaptation of a prefabricated guide to the surgical site, ensuring firm stabilization. Implant positions were marked, and after the removal of the guide, a crestal incision was made. A mucoperiosteal flap was reflected, exposing the maxillary sinus and alveolar crest. The guide was readapted, marking implant positions, and a lateral window was formed using a bur or piezotome. Sinus membrane elevation was performed carefully. Implants were placed with graft material beneath the elevated membrane. In cases of bony plate preservation, the window was covered. In Group 2 (Lateral Maxillary Sinus Floor Elevation without a surgical guide), a crestal incision and mucoperiosteal flap exposed the sinus. A bony window was created, and careful elevation of the sinus floor followed. Implant osteotomies were completed, and graft material was packed into the sinus. A resorbable membrane was applied, and the flap was sutured. NanoboneÒ was used as the standard graft material in both groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult patients (over 18 years of age), without any systemic complication.\n* Patients who need for dental implant in posterior maxilla with bone height below the maxillary sinus is \\< 6 mm.\n* Non smokers or patients who smoked less than 11 cig/day Will be included.\n\nExclusion Criteria:\n\n* Uncontrolled systemic diseases which affect bone healing.\n* Presence of any pathology in the site of operation.'}, 'identificationModule': {'nctId': 'NCT06130657', 'briefTitle': 'Volumetric Analysis of Maxillary Sinus After Guided Lateral Sinus Lift Procedure', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Volumetric Analysis of Maxillary Sinus After Guided Lateral Sinus Lift Procedure With Simultaneous Implant Placement', 'orgStudyIdInfo': {'id': 'AUAREC202100012-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1: Lateral Maxillary Sinus Floor Elevation using surgical guide', 'interventionNames': ['Procedure: Lateral Maxillary Sinus Floor Elevation using surgical guide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2: Lateral Maxillary Sinus Floor Elevation without surgical guide', 'interventionNames': ['Procedure: Lateral Maxillary Sinus Floor Elevation without surgical guide']}], 'interventions': [{'name': 'Lateral Maxillary Sinus Floor Elevation using surgical guide', 'type': 'PROCEDURE', 'description': 'The surgical procedure begins with securing a prefabricated guide firmly to the surgical site. Implant positions are marked, and after guide removal, a crestal incision is made 1 mm palatal to the marked point, extending with sulcular and vertical incisions. A full-thickness mucoperiosteal flap is reflected to expose the maxillary sinus and alveolar crest. After readapting the surgical guide to the bone, implant positions are marked, and cutting edges are tracked. The lateral window is formed by extending and connecting mesial and distal borders, created using piezotome. The sinus membrane is carefully reflected and elevated with a surgical curette to avoid iatrogenic perforation. Implant fixtures are then placed using the identical surgical guide, followed by graft material placement beneath the elevated sinus membrane. If the bony plate is preserved, the lateral window is covered with the plate.', 'armGroupLabels': ['Group 1: Lateral Maxillary Sinus Floor Elevation using surgical guide']}, {'name': 'Lateral Maxillary Sinus Floor Elevation without surgical guide', 'type': 'PROCEDURE', 'description': "The sinus's lateral wall is exposed through a crestal incision and a mucoperiosteal flap. A bony window is created, and upon its removability, the sinus floor is carefully elevated using sinus elevation curettes, taking care to avoid membrane perforation. In cases of perforation, a resorbable collagen membrane is applied to cover the hole. Implant osteotomies are then completed following the standard sequential placement protocol. Graft material, mixed with normal saline, is gently packed into the sinus to fill the cavity with bone substitute material and achieve the desired bone height. Finally, a resorbable membrane is placed on the outer surface of the window, and the flap is sutured for primary closure.", 'armGroupLabels': ['Group 2: Lateral Maxillary Sinus Floor Elevation without surgical guide']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Faculty of Dental Medicine', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ahmed Zewail', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Resident at the Department of Oral and Maxillofacial Surgery', 'investigatorFullName': 'Ahmed Zewail', 'investigatorAffiliation': 'Al-Azhar University'}}}}