Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 10:05 PM
Study NCT ID:
NCT07150858
Status:
RECRUITING
Last Update Posted:
2025-09-02
First Post:
2025-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Erythropoietin - Albumin Platelet-rich Fibrin in Transcrestal Sinus Lifting With Simultaneous Implant Placement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004921', 'term': 'Erythropoietin'}], 'ancestors': [{'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-07-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2025-08-27', 'studyFirstSubmitQcDate': '2025-08-27', 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-07-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain scores', 'timeFrame': 'up to 14 days', 'description': 'pain will be assessed through a 10 point visual analogue scale (VAS). (0-1=none, 2-4=mild, 5-7=moderate, 8-10=severe).'}, {'measure': 'Change in edema', 'timeFrame': 'up to 14 days', 'description': 'Edema will be assessed as follows:\n\n1. None (no swelling)\n2. Mild (intraoral swelling confined to the surgical field)\n3. Moderate (extra oral swelling in the surgical zone)\n4. Severe (extraoral swelling spreading beyond the surgical zone)'}, {'measure': 'Change in implant stability', 'timeFrame': 'immediate and 4 months', 'description': 'implant stability will be assessed using ostell device'}], 'secondaryOutcomes': [{'measure': 'Change in bone gain', 'timeFrame': 'baseline and 4 months', 'description': 'amount of sinus bone gain (SBG) which equals implant protrusion length (IPL) added to Peri-implant sinus bone level (PSBL) which is the distance between the apex of the implant and sinus bone level'}, {'measure': 'Change in bone density', 'timeFrame': 'baseline and 4 months', 'description': 'it will be assessed using CBCT'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transcrestal sinus lifting, erythropoitein, albumin PRF, Peizo electric device, Dental implants, CBCT.'], 'conditions': ['Sinus Lifting']}, 'descriptionModule': {'briefSummary': 'Background: Dental implant therapy in the posterior maxilla may be difficult owing to limited bone height after dental extraction with sinus pneumatization. Several approaches for sinus floor elevation have been documented, and hence trans crestal sinus lifting with albumin platelet rich plasma.\n\nAim of the study: To compare between erythropoietin and albumin platelet rich fibrin transcrestal sinus lifting versus albumin platelet rich fibrin transcrestal sinus lifting using piezoelectric device in patients with atrophic maxilla.\n\nMethods: This study will be carried out as a randomized'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Residual bone height not less than 5 mm measured from crestal bone to sinus floor.\n* Both genders.\n* Good oral hygiene\n* No previous surgery or radiation treatment on the maxillary sinus\n\nExclusion Criteria:\n\n* Recent radiation therapy in maxilla.\n* Uncontrolled systemic diseases such as diabetes mellitus.\n* Heavy smoker (those who smoke ≥ 25 cigarettes a day).\n* Alcohol abuse.\n* Patient on anticoagulant drug\n* Severe allergic rhinitis.\n* Tumor or large cyst in the maxillary sinus.\n* Oroantral fistula.\n* Presence of acute or chronic sinus pathoses or sinus membrane perforation.('}, 'identificationModule': {'nctId': 'NCT07150858', 'briefTitle': 'Erythropoietin - Albumin Platelet-rich Fibrin in Transcrestal Sinus Lifting With Simultaneous Implant Placement', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Comparison Between Erythropoietin-enhanced Albumin Platelet-rich Fibrin and Albumin Platelet-rich Fibrin in Transcrestal Sinus Lifting With Simultaneous Implant Placement', 'orgStudyIdInfo': {'id': '1073-5/2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Erythropoietin and albumin PRF gel', 'interventionNames': ['Other: Erythropoietin and albumin PRF gel + implant placement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'albumin PRF gel', 'interventionNames': ['Other: Albumin PRF gel +implant placement']}], 'interventions': [{'name': 'Erythropoietin and albumin PRF gel + implant placement', 'type': 'OTHER', 'description': 'This group will be treated by transcrestal sinus lifting with erythropoietin and albumin PRF gel with simultaneous implant placement.', 'armGroupLabels': ['Erythropoietin and albumin PRF gel']}, {'name': 'Albumin PRF gel +implant placement', 'type': 'OTHER', 'description': 'This group (the Control group) will be treated with transcrestal sinus lifting using albumin PRF gel, with simultaneous implant placement.', 'armGroupLabels': ['albumin PRF gel']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Hassan M Ruzyqat, BDS', 'role': 'CONTACT', 'email': 'hassanmohammadrziqat@gmail.com', 'phone': '01555767730'}, {'name': 'Hassan M Ruzyqat, 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': 'Hassan M Ruzyqat, BDS', 'role': 'CONTACT', 'email': 'hassanmohammadrziqat@gmail.com', 'phone': '01555767730'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}