Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 12:25 AM
Study NCT ID:
NCT05044260
Status:
UNKNOWN
Last Update Posted:
2021-09-14
First Post:
2021-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sinus Lift Using PTFE Titanium Reinforced Membrane
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': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-10-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-06', 'studyFirstSubmitDate': '2021-09-06', 'studyFirstSubmitQcDate': '2021-09-06', 'lastUpdatePostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in implant stability', 'timeFrame': 'at baseline and 6 months', 'description': 'It will be measured using Osstell'}, {'measure': 'Change in bone formation', 'timeFrame': 'at baseline and 6 months', 'description': 'It will be measured uisng CBCT on Demand 3d software'}, {'measure': 'Change in bone height', 'timeFrame': 'at baseline and 6 months', 'description': 'It will be measured uisng CBCT on Demand 3d software'}, {'measure': 'Change in bone density', 'timeFrame': 'at baseline and 6 months', 'description': 'It will be measured uisng CBCT on Demand 3d software'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sinus Lift']}, 'descriptionModule': {'briefSummary': 'Various attempts have been implemented using different materials and techniques to augment the maxillary sinus floor enhancing autogenous bone formation to allow proper dental implant positioning. The aim of this study is to evaluate the sinus lift procedure using polytetrafluoroethylene (PTFE) titanium-reinforced membrane to maintain the space formed after Schneiderian membrane elevation followed by immediate implant placement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of both genders requiring implant placement in posterior maxilla\n* Age range: 40-60 years.\n* Good oral hygiene\n* Healthy maxillary sinus free from pathology\n* The minimum crestal bone height is (4-6) mm\n* Patients who are willing and fully capable to comply with the study protocol.\n\nExclusion Criteria:\n\n* Sinus infection\n* Tumors or pathologic lesions in sinus\n* Severe allergic rhinitis.\n* Chronic topical steroid use.\n* Radiation therapy.\n* Psychologic / mental impairment\n* Acute infection (periodontitis or mucosal infection\n* Patients on radiotherapy or chemotherapy.\n* Alcohol or drug abuse.\n* Patient with systemic disorder (uncontrolled Diabetes mellitus, autoimmune diseases, bone diseases, etc.)\n* Smokers\n* Parafuctional habits'}, 'identificationModule': {'nctId': 'NCT05044260', 'briefTitle': 'Sinus Lift Using PTFE Titanium Reinforced Membrane', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Evaluation of Direct Sinus Lift Using Ptfe Titanium Reinfored Membrane Assosiated With Immediate Implant Placement (Clinical Trial)', 'orgStudyIdInfo': {'id': 'sinus_lift2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Direct Sinus elevation using SLA Kit', 'interventionNames': ['Procedure: Direct sinus lift with titanium reinforced PTFE membrane']}], 'interventions': [{'name': 'Direct sinus lift with titanium reinforced PTFE membrane', 'type': 'PROCEDURE', 'description': 'Implants will be placed immediately after sinus lifting procedure and maintaining the sinus membrane in position using PTFE titanium reinforced membrane.', 'armGroupLabels': ['Direct Sinus elevation using SLA Kit']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Alexandria Faculty of Dentistry', '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'}}}}