Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2026-01-17 @ 7:12 AM
Study NCT ID:
NCT04625192
Status:
UNKNOWN
Last Update Posted:
2020-11-12
First Post:
2020-11-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trephine Osteotomy in Lateral Sinus Lift
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-06', 'studyFirstSubmitDate': '2020-11-06', 'studyFirstSubmitQcDate': '2020-11-06', 'lastUpdatePostDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Implant stability', 'timeFrame': 'at baseline and 6 months', 'description': 'This will be measured by implant stability meter (OsstellTM)'}, {'measure': 'change in bone density', 'timeFrame': 'at baseline, 3rd and 6th months', 'description': 'Panoramic radiography will be performed immediately postoperatively and cone beam computed tomography (CBCT)'}, {'measure': 'change in bone volume', 'timeFrame': 'at baseline, 3rd and 6th months', 'description': 'Panoramic radiography will be performed immediately postoperatively and cone beam computed tomography (CBCT)'}, {'measure': 'change in bone vertical bone height', 'timeFrame': 'at baseline, 3rd and 6th months', 'description': 'Panoramic radiography will be performed immediately postoperatively and cone beam computed tomography (CBCT)'}], 'secondaryOutcomes': [{'measure': 'post operative pain', 'timeFrame': 'after 1 week', 'description': 'This will be assessed using a 10-point Visual Analogue Scale (VAS) in the 1st week postoperatively.\n\n(0-1=None, 2-4=Mild-Moderate, 8-10= Severe)'}, {'measure': 'Postoperative edema', 'timeFrame': 'after 1 week', 'description': '* None (no inflammation).\n* Mild (intraoral swelling confined to the surgical field).\n* Moderate (extraoral swelling in the surgical zone).\n* Severe (extraoral swelling spreading beyond the surgical zone'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sinus Lift']}, 'descriptionModule': {'briefSummary': 'Trephine osteotomy was used for lateral sinus lifting technique associated with sinus floor augmentation using the autogenous bone resulting from implant drilling using specialized trephine drills.', 'detailedDescription': 'The study includes 14 patients in whom the lateral sinus lift technique was performed using the trephine osteotomy with simultaneous implant placement.\n\nSinus floor augmentation with autogenous bone graft resulting from implant site preparation with trephine drills.\n\nImplant stability and rate of complications such as Schneiderian membrane perforation and bleeding will be assessed.\n\nPatients will also provide their subjective assessment of postoperative pain and swelling. Vertical bone height, that will be gained, will be assessed radiographically'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of both genders requiring implant placement in the posterior maxilla.\n* Age between 20-50 years.\n* Tooth extractions at the implant sites were performed at least 4 months before surgery.\n* Residual bone height between the alveolar bone crest and the sinus floor ranges from 4 to 6 mm.\n* Patients who are willing and fully capable to comply with the study protocol\n\nExclusion Criteria:\n\n* Maxillary sinus pathologies (sinusitis, long standing nasal obstruction)\n* Any disease contraindicating surgery (e.g. uncontrolled diabetes)\n* Heavy smokers\n* Acute oral infections\n* Poor oral hygiene\n* A history of radiotherapy or chemotherapy of the head and neck region'}, 'identificationModule': {'nctId': 'NCT04625192', 'briefTitle': 'Trephine Osteotomy in Lateral Sinus Lift', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Lateral Sinus Lift Technique Using Trephine Osteotomy With Simultaneous Implant Placement (Clinical Trial)', 'orgStudyIdInfo': {'id': 'Trephine osteotomy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sinus lifting with trephine osteotomy', 'interventionNames': ['Procedure: Trephine osteotomy']}], 'interventions': [{'name': 'Trephine osteotomy', 'type': 'PROCEDURE', 'description': '* Using a trephine on a straight implant handpiece (at approximately 1800 rpm) with copious irrigation to avoid overheating the bone, a round bone cut will be made 4 -5 mm above the crest of the alveolar ridge.\n* The trephine is positioned perpendicular to the lateral wall, removing the outer cortex with a very gentle touch to avoid tearing the schneiderian membrane.', 'armGroupLabels': ['Sinus lifting with trephine osteotomy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Alexandria University', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}]}, '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'}}}}