Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT05831267
Status:
COMPLETED
Last Update Posted:
2023-04-26
First Post:
2023-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fibrin Glue Versus Titanium Platelet-rich Fibrin in Lateral Sinus Lifting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015718', 'term': 'Fibrin Tissue Adhesive'}], 'ancestors': [{'id': 'D005337', 'term': 'Fibrin'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-14', 'studyFirstSubmitDate': '2023-04-14', 'studyFirstSubmitQcDate': '2023-04-14', 'lastUpdatePostDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in implant stability', 'timeFrame': 'Baseline and 6 months', 'description': 'implant stability will be measures using Ostell device.'}, {'measure': 'change in bone density', 'timeFrame': 'Baseline and 6 months', 'description': 'bone density will be measured using CBCT'}, {'measure': 'change in vertical bone height', 'timeFrame': 'Baseline and 6 months', 'description': 'vertical bone height will be measured using CBCT'}], 'secondaryOutcomes': [{'measure': 'change in pain intensity', 'timeFrame': 'Through 1 week postopertaive', '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, 5-7= Moderate, 8-10= Severe)'}, {'measure': 'Change in edema score', 'timeFrame': 'Through 1 week postopertaive', 'description': 'The score will be as follows:\n\n* 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': {'keywords': ['Tenting implant', 'Fibrin glue', 'T-PRF'], 'conditions': ['Sinus Floor Augmentation', 'Graftless Sinus Elevation']}, 'descriptionModule': {'briefSummary': 'Graftless sinus lift with simultaneous implant placement is one of the new techniques, this new technique is presented based on the physiology of intrasinus bone repair.\n\nSchneiderian membrane is known to have an osteogenic nature, now blood clot can be considered autologous osteogenic graft material, to which osteoprogenitors can migrate, differentiate, and regenerate bone.\n\nThe aim of this study is to evaluate the effectiveness of using Fibrin glue versus Titanium platelet rich fibrin (T-PRF) as a sole filling material in lateral sinus lifting using with simultaneous implant placement in comparison to a negative control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients requiring implant placement in the posterior maxilla.\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 is 3-5 mm\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 (smoke greater than or equal 25 cigarettes daily).\n* Acute oral infections.\n* Untreated periodontal disease (gingival index 2 and 3).\n* Poor oral hygiene ( Silness-Löe index (score 2-3) ).\n* A history of radiotherapy or chemotherapy of the head and neck region.\n* Pregnancy.'}, 'identificationModule': {'nctId': 'NCT05831267', 'briefTitle': 'Fibrin Glue Versus Titanium Platelet-rich Fibrin in Lateral Sinus Lifting', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Fibrin Glue Versus Titanium Platelet-rich Fibrin as a Sole Filling Material in Lateral Sinus Lifting With Simultaneous Implant Placement (Randomized Controlled Clinical Trial )', 'orgStudyIdInfo': {'id': 'Sinus_lifting_2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group 1', 'interventionNames': ['Other: Fibrin Glue']}, {'type': 'EXPERIMENTAL', 'label': 'Study group 2', 'interventionNames': ['Other: T-PRF']}, {'type': 'OTHER', 'label': 'Control group', 'interventionNames': ['Other: Negative control']}], 'interventions': [{'name': 'Fibrin Glue', 'type': 'OTHER', 'description': 'Blood samples were collected from the antecubital vein of the right or left arm of the patient and drawn into sterile Titanium tubes immediately. The tubes were then centrifuged for 12 minutes at 2800 rpm and room temperature', 'armGroupLabels': ['Study group 1']}, {'name': 'T-PRF', 'type': 'OTHER', 'description': 'The contents of the two containers (human fibrinogen, human thrombin) will be mixed with distilled water and then aspirated by two syringes after that, the two solutions will be mixed together and injected into the empty compartment around the dental implant under the sinus mucosal lining using auto mixing applicator.', 'armGroupLabels': ['Study group 2']}, {'name': 'Negative control', 'type': 'OTHER', 'description': 'this group will not receive any material.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00203', 'city': 'Alexandria', 'state': 'Azarita', 'country': 'Egypt', 'facility': 'Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt', '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'}}}}