Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-02-26 @ 12:46 AM
Study NCT ID:
NCT05922592
Status:
COMPLETED
Last Update Posted:
2023-06-28
First Post:
2023-06-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Different Techniques of Crestal Sinus Lift
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': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-19', 'studyFirstSubmitDate': '2023-06-19', 'studyFirstSubmitQcDate': '2023-06-19', 'lastUpdatePostDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Height gain', 'timeFrame': '6 months', 'description': 'Bone height after the surgery measured on CBCT 6-months postoperative \\_ Residual bone height at implant placement'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Crestal Sinus Lift']}, 'referencesModule': {'references': [{'pmid': '39118095', 'type': 'DERIVED', 'citation': 'Alajami MM, Elsheikh HA, Abo El-Farag SA, Mansour NA. Antral membrane balloon technique versus Densah bur in crestal sinus lift with simultaneous implant placement: a randomized clinical trial. BMC Oral Health. 2024 Aug 8;24(1):916. doi: 10.1186/s12903-024-04609-8.'}]}, 'descriptionModule': {'briefSummary': 'Sixteen patients will be selected from those attending the outpatient clinic of the Oral \\& Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University with age range from 20-50 years seeking implantation of their lost posterior maxillary teeth, \\[premolar and molars\\] with limited bone height below the floor of the maxillary sinus, secondary to sinus pneumatization.\n\nGroup I (N = 8): The sinus membrane will be elevated by using balloon technique with simultaneous Implant placement.\n\nGroup II (N = 8): The sinus membrane will be elevated by using Densah burs with simultaneous Implant placement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patent ostium of maxillary sinus.\n* Patient with missing one or more posterior maxillary teeth.\n* A ridge height at the site of implantation of 4-7 mm.\n* A ridge width at the site of implantation of 6 mm.\n* Good oral hygiene.\n* Patients in the age frame between 20 years and 50 years old.\n* No gender preface in selection of the patients.\n* Acceptable inter-arch space for the future prosthesis.\n\nExclusion Criteria:\n\n* Any pathological condition at the site of surgery.\n* Patients with systemic diseases that contra-indicate the surgical procedure such as uncontrolled diabetes mellitus, bleeding disorders, serious osseous disorders, and mental disorders.\n* Heavy smoking and alcoholism.\n* Parafunctional habits such as bruxism and clenching.\n* Signs of acute infection or pus discharge\n* Disturbed occlusion.\n* Maxillary sinus inflammation.'}, 'identificationModule': {'nctId': 'NCT05922592', 'briefTitle': 'Different Techniques of Crestal Sinus Lift', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Balloon Technique Versus Densah Bur in Crestal Sinus Lift Operation With Simultaneous Implant Placement. A Prospective Study', 'orgStudyIdInfo': {'id': 'A08030123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The sinus membrane will be elevated by using balloon technique with simultaneous Implant placement.', 'interventionNames': ['Procedure: crestal sinus lift using ballon technique']}, {'type': 'EXPERIMENTAL', 'label': 'The sinus membrane will be elevated by using Densah burs with simultaneous Implant placement', 'interventionNames': ['Procedure: crestal sinus lift using densah burs']}], 'interventions': [{'name': 'crestal sinus lift using ballon technique', 'type': 'PROCEDURE', 'description': 'The sinus membrane will be elevated by using balloon technique with simultaneous Implant placement.', 'armGroupLabels': ['The sinus membrane will be elevated by using balloon technique with simultaneous Implant placement.']}, {'name': 'crestal sinus lift using densah burs', 'type': 'PROCEDURE', 'description': 'The sinus membrane will be elevated by using Densah burs with simultaneous Implant placement', 'armGroupLabels': ['The sinus membrane will be elevated by using Densah burs with simultaneous Implant placement']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Mohamed Mahmoud', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'postgraduate student at oral an maxillofacial surgery department', 'investigatorFullName': 'Mohamed mahmoud alajami', 'investigatorAffiliation': 'Mansoura University'}}}}