Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2026-01-01 @ 2:14 AM
Study NCT ID:
NCT06766292
Status:
COMPLETED
Last Update Posted:
2025-08-11
First Post:
2025-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Osteogenic Potential of Schneiderian Membrane
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-07', 'studyFirstSubmitDate': '2025-01-05', 'studyFirstSubmitQcDate': '2025-01-05', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bone height', 'timeFrame': '8 months', 'description': 'will be measured using CBCT (Cone Beam Computed Tomography)'}], 'secondaryOutcomes': [{'measure': 'histological analysis', 'timeFrame': '8 months', 'description': 'will be measured using hematoxylin and eosin stains'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sinus lifting', 'maxillary sinus augmentation'], 'conditions': ['Bone Healing', 'Sinus Membrane Osteoginicity']}, 'descriptionModule': {'briefSummary': 'Maxillary sinus augmentation is commonly performed by creating a space below the Schneiderian membrane which is further filled using autografts, bone graft substitutes, or a combination of both to allow for new bone formation. Recently, a new method called non-grafting sinus floor augmentation has been introduced as an alternative approach. This method is based on the idea of elevating the membrane and supporting it through implant insertion or the use of space-maintaining devices like titanium screws or mesh. This study was conducted to evaluate the efficacy of new bone formation after sinus floor elevation using space maintaining resorbable pins without graft material.', 'detailedDescription': 'A randomized control trial was performed on 14 patients with partially edentulous or free end saddle posterior maxilla. The patients were divided randomly into two groups. Both groups underwent maxillary sinus open lifting procedure and augmentation using xenograft \\* as group A and in group B the sinus membrane was elevated and stabilized by resorbable pins\\*\\* to maintain the created space stable and without grafting. The study was a double blind one (participants and out¬come assessors were blinded throughout the study).\n\nAll the surgical procedures were carried out un¬der local anesthesia using infraorbital and posterior superior alveolar nerve block with palatal infiltration. Full thickness mucoperiosteal flap was elevated to expose the lateral wall of the maxillary sinus. Then the maxil¬lary sinus floor elevation using the lateral window technique was performed. A bone window was outlined using a no. 8 diamond bur mounted on straight hand piece with copious irrigation (sterile saline solution) with cautious taken to not penetrate the sinus membrane. The process of bone removal was done through the cortical bone to reach the membrane without perforation. Complete osteotomy along the boundary of the osseous window until the Schneiderian mem-brane. The Schneiderian membrane was carefully elevated till the desired height.\n\nxenograft Preparation: (control group/ group A)\n\nXenograft was mixed with saline followed by the protocol of graft packed and compacted against inferior walls and to the sides of the antrum until the new available volume created was filled. The lateral window was covered by collagen membrane before flap closure. Resorbable pins (test group/ group B):\n\nIn the study group: 2.0 mm screws were fixed to the lateral wall of the sinus above the superior osteotomy and placed buccopalatally where the schneiderian membrane was elevated and maintained. Then the soft tissue flap was readapted and sutured using continuous and interrupted sutures (3-0 resorbable vicryl)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult male/female patients above the age of 25.\n2. Patients with one or more teeth requiring implant supported dental restoration in atrophic maxilla (unilateral or bilateral).\n3. Alveolar bone height less than 4 mm at the defective site.\n4. Good oral hygiene.\n\nExclusion Criteria:\n\n1. Medically compromised patients with conditions contraindicating surgery (eg. uncontrolled diabetics, bisphosphonate intake, radio or chemotherapy).\n2. Patients with active infection at or related to the site of surgery (eg. acute sinusitis).\n3. Heavy smokers.\n4. Patients not indicated for an implant supported restoration at the time of enrollment (eg. active/untreated periodontal disease).'}, 'identificationModule': {'nctId': 'NCT06766292', 'briefTitle': 'Osteogenic Potential of Schneiderian Membrane', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Clinical, Radiographic and Histologic Assessment of the Osteogenic Potential of Schneiderian Membrane After Maxillary Sinus Lifting: A Randomized Controlled Clinical Trial.', 'orgStudyIdInfo': {'id': '672/2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'in this group, the patients underwent open sinus lifting surgery and augmentation of the sinuses by xenograft without any additives', 'interventionNames': ['Procedure: open sinus lifting with xenograft only']}, {'type': 'EXPERIMENTAL', 'label': 'study group', 'description': 'In the study group: 2.0 mm screws were fixed to the lateral wall of the sinus above the superior osteotomy and placed buccopalatally where the schneiderian membrane was elevated and maintained.', 'interventionNames': ['Procedure: primary intervention']}], 'interventions': [{'name': 'primary intervention', 'type': 'PROCEDURE', 'description': 'In the study group: 2.0 mm screws were fixed to the lateral wall of the sinus above the superior osteotomy and placed buccopalatally where the schneiderian membrane was elevated and maintained. this technique will suspends the membrane in position to allow the blood clot to organized and formation of bone.', 'armGroupLabels': ['study group']}, {'name': 'open sinus lifting with xenograft only', 'type': 'PROCEDURE', 'description': 'll Patients in this group underwent open sinus procedures to lift the sinus membrane followed by application of the xenograft as an augmentation material xenograft is used instead of autogenous bone graft to avoid the morbidity of the donor side', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41522', 'city': 'Ismailia', 'country': 'Egypt', 'facility': 'Suez Canal University', 'geoPoint': {'lat': 30.60427, 'lon': 32.27225}}], 'overallOfficials': [{'name': 'rehab soliman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Misr International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'rehab soliman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'lecturer of oral and maxillofacial surgery', 'investigatorFullName': 'rehab soliman', 'investigatorAffiliation': 'Ain Shams University'}}}}