Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-25 @ 4:40 PM
Study NCT ID:
NCT04688957
Status:
UNKNOWN
Last Update Posted:
2020-12-30
First Post:
2020-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Osseodensification by Densah Burs Versus Osteotome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2021-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-26', 'studyFirstSubmitDate': '2020-12-18', 'studyFirstSubmitQcDate': '2020-12-26', 'lastUpdatePostDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'implant stability', 'timeFrame': 'at 6 months', 'description': 'Using the Osstell, The result is presented as an ISQ value of 1-100. The higher the ISQ, the more stable the implant'}, {'measure': 'change in bone height', 'timeFrame': 'at baseline and 6 months', 'description': 'using CBCT'}, {'measure': 'change in bone density', 'timeFrame': 'at baseline and 6 months', 'description': 'using CBCT'}], 'secondaryOutcomes': [{'measure': 'Pain scores', 'timeFrame': 'at 2 weeks', 'description': '10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)'}, {'measure': 'edema scores', 'timeFrame': 'at 2 weeks', 'description': 'The pitting is graded on a scale of +1 to +4 as follows:\n\n* +1 (trace) slight indentation rapid return to normal.\n* +2 (mild) the indentation returns to normal in a few seconds.\n* +3 (moderate) 6 mm indentation rebounds in 10-20 seconds.\n* +4 (severe) 8 mm indentation rebounds in more than 30 seconds.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Maxillary Sinus Lift']}, 'referencesModule': {'references': [{'pmid': '35840446', 'type': 'DERIVED', 'citation': 'Elghobashy MTM, Shaaban AM, Melek LNF. Radiographic comparison between Densah burs and osteotome for graftless internal sinus lifting with simultaneous implant placement: a randomized clinical trial. Int J Oral Maxillofac Surg. 2023 Mar;52(3):388-395. doi: 10.1016/j.ijom.2022.06.020. Epub 2022 Jul 13.'}]}, 'descriptionModule': {'briefSummary': 'implant placement in the posterior maxilla is problematic, not only due to inferior properties of bone but also due to loss of vertical bone height which happens after extraction of posterior teeth. when the required additional height is few millimeters, indirect transcresta sinus lifting procedures are recommended.\n\nThis study compares sinus lifting using the conventional osteotome versus the osseodensification with densah burs.', 'detailedDescription': 'a total of 12 patients with missing maxillary premolars or molars and with limited vertical bone height below the maxillary sinus floor will receive implants either with osteotome or with Densah burs transcrestal sinus lifting to compare clinically and radiographically transcrestal sinus lifting with Densah burs and osteotome with simultaneous implant placement'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with missing maxillary premolas and molars\n* Vertical bone height of 5-8 mm\n* Non smokers\n* Good oral hygiene\n\nExclusion Criteria:\n\n* Bad oral hygiene\n* maxillary sinusitis\n* Presence of infection or periapical lesions in adjacent teeth\n* Bruxism or clenching\n* Alcoholism\n* Medically compromised patients with a condition that affect the procedure\n* Multiple sinus septa'}, 'identificationModule': {'nctId': 'NCT04688957', 'briefTitle': 'Osseodensification by Densah Burs Versus Osteotome', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Osseodensification by Densah Burs Versus Osteotome for Transcrestal Maxillary Sinus Lifting With Simultaneous Implant Placement (Randomized Clinical Trial)', 'orgStudyIdInfo': {'id': 'osseodensifcation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'osteotome sinus lifting', 'interventionNames': ['Procedure: osteotome sinus lifting']}, {'type': 'EXPERIMENTAL', 'label': 'oseodensification sinus lifting', 'interventionNames': ['Procedure: oseodensification sinus lifting']}], 'interventions': [{'name': 'oseodensification sinus lifting', 'type': 'PROCEDURE', 'description': 'application of first densah bur with densifying mood (reverse) counterclockwise, 1200 revolution per minute until the sinus is reached then use a wider densah bur with the same mode and bouncing motion to elevate the sinus floor up to 3 mm in 1mm increments.', 'armGroupLabels': ['oseodensification sinus lifting']}, {'name': 'osteotome sinus lifting', 'type': 'PROCEDURE', 'description': 'drilling implant site with consecutive drills short of the sinus floor by 1-2mm , using osteotome in appropriate size and application of one tap until sinus floor is elevated, using the final drill for the desired implant diameter', 'armGroupLabels': ['osteotome sinus lifting']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohammed T Elghobashy, BDS', 'role': 'CONTACT', 'email': 'abotalaat20112371993@gmail.com', 'phone': '01112158436', 'phoneExt': '002'}, {'name': 'Mohammed T Elghobashy, BDS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'centralContacts': [{'name': 'Mohammed T Elghobashy, BDS', 'role': 'CONTACT', 'email': 'abotalaat20112371993@gmil.com', 'phone': '011121158436', 'phoneExt': '002'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hams Hamed Abdelrahman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer of DPH and Clinical statistician', 'investigatorFullName': 'Hams Hamed Abdelrahman', 'investigatorAffiliation': 'Alexandria University'}}}}