Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-01-07 @ 3:51 PM
Study NCT ID:
NCT05166434
Status:
UNKNOWN
Last Update Posted:
2021-12-22
First Post:
2021-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment Crestal Maxillary Sinus Membrane Elevation Using Different Implant Heights
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-20', 'studyFirstSubmitDate': '2021-12-07', 'studyFirstSubmitQcDate': '2021-12-20', 'lastUpdatePostDateStruct': {'date': '2021-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measuring bone formation and density beyond apical part of dental implant after closed sinus lifting', 'timeFrame': '4 months after Dental implant placement', 'description': 'CBCT superimposition of the Pre-operative and Post-operative'}], 'secondaryOutcomes': [{'measure': 'Measuring secondary stability of dental implants', 'timeFrame': '4 months after Dental implant placement', 'description': 'osttell device (ISQ)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Stability, implant. sinus lifting, bone formation'], 'conditions': ['Bone Formation Around Implant After Crestal Sinus Lifting']}, 'descriptionModule': {'briefSummary': 'This study is aiming to evaluate primary stability and bone gain in trans-crestal osseodencification technique using Regular concaved osteotomes at different height elevations.', 'detailedDescription': 'For those patient who need up to 2-6 mm of vertical height, the 1-stage transcrestal osteotome technique shown to be stable over long term.\n\nThe most important negative factor that can be inferred from the results is that BAOSFE becomes less predictable when there is 4 mm or less of preexisting alveolar bone height beneath the sinus. Moreover, more challenging situation is the magnitude of tapping force, which may accidently perforate the antral membrane causing a lot of complication in the naso-antral apparatus by excessive taping force. The expansion of the osteotomy sites is performed with a number of Concave tipped tapered osteotomes with increasing diameters that are applied through the edentulous alveolar crest at the inferior border of the maxillary sinus floor. With each insertion of a larger osteotome, bone is compressed, pushed laterally and apically while pushing the garnered bone apically beneath the tented membrane.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with edentulous vertically deficient posterior maxillary ridge a minimum 4 mm height of alveolar bone, and 6 mm in width.\n* Both males as well as females without any active periodontal disease.\n* All patients are in a good health with no systemic, immunologic or debilitating diseases that could affect normal bone healing.\n* All selected patients are non-smokers and non-alcoholics.\n* Patients are free from T.M.J troubles, abnormal oral habits such as bruxism.\n* The edentulous ridges are covered with optimal thickness of mucoperiosteum with no signs of inflammation, ulceration or scar tissue.\n* Remaining natural teeth have good periodontal tissue support and occlusion showed sufficient inter arch space for future prosthesis.\n\nExclusion Criteria:\n\n1. On the local level, patients with maxillary sinus diseases, former sinus surgery and unfavorable inter maxillary relationship will be excluded.\n2. General contraindications to implant surgery.\n3. Subjected to irradiation in the head and neck area less than 1 year before implantation.\n4. Untreated periodontitis.\n5. Poor oral hygiene and motivation.\n6. Uncontrolled diabetes.\n7. Pregnant or nursing.\n8. Substance abuse.\n9. Psychiatric problems or unrealistic expectations.\n10. Severe bruxism or clenching.\n11. Immunosuppressed or immunocompromised.\n12. Treated or under treatment with intravenous amino-bisphosphonates.\n13. Lack of opposite occluding dentition/prosthesis in the area intended for implant placement.\n14. Active infection or severe inflammation in the area intended for implant placement.\n15. Need of bone augmentation procedures at implant placement.\n16. Unable to open mouth sufficiently to accommodate the surgical tooling.\n17. Patients participating in other studies, if the present protocol could not be properly followed.\n18. Referred only for implant placement or unable to attend a 5-year follow-up.\n19. Requiring only single implant-supported crowns.'}, 'identificationModule': {'nctId': 'NCT05166434', 'briefTitle': 'Assessment Crestal Maxillary Sinus Membrane Elevation Using Different Implant Heights', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Radiographic Assessment of Crestal Maxillary Sinus Membrane Elevation Using Different Dental Implant Heights in Atrophic Posterior Maxilla', 'orgStudyIdInfo': {'id': 'o m f s 335'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'bone formation around implant at 2mm membrane elevation crestal sinus lifting', 'interventionNames': ['Procedure: trans-crestal sinus lifting']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'bone formation around implant at 4mm membrane elevation crestal sinus lifting', 'interventionNames': ['Procedure: trans-crestal sinus lifting']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'bone formation around implant at 6mm membrane elevation crestal sinus lifting', 'interventionNames': ['Procedure: trans-crestal sinus lifting']}], 'interventions': [{'name': 'trans-crestal sinus lifting', 'type': 'PROCEDURE', 'otherNames': ['Closed sinus lifting'], 'description': 'this study will be divided in to three different groups, each group will receive a same technique of Crestal maxillary sinus lifting and implant placement at 2,4,6 mm heights.', 'armGroupLabels': ['bone formation around implant at 2mm membrane elevation crestal sinus lifting', 'bone formation around implant at 4mm membrane elevation crestal sinus lifting', 'bone formation around implant at 6mm membrane elevation crestal sinus lifting']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11553', 'city': 'Cairo', 'state': 'Giza Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohammad m Khashaba, PHD', 'role': 'CONTACT', 'email': 'mohammedkhashaba@hotmail.com', 'phone': '01227754765', 'phoneExt': '0020'}, {'name': 'Mohammad m Atef, PHD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mohammad m Khashaba', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Maher m Maqbol', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Maher Mohammed Hebah Maqbol'}], 'centralContacts': [{'name': 'Maher mohammad Maqbol, BDS', 'role': 'CONTACT', 'email': 'maher.maqbol@dentistry.cu.edu', 'phone': '01141722802', 'phoneExt': '0020'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Maher Mohammed Hebah Maqbol', 'investigatorAffiliation': 'Cairo University'}}}}