Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2026-01-04 @ 1:28 PM
Study NCT ID:
NCT05492357
Status:
COMPLETED
Last Update Posted:
2022-11-09
First Post:
2022-08-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Recurrent Application of Liquid-PRF on Hard and Soft Tissues
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Human patients:\n\n20 patients who need tooth/ teeth extraction would be selected according to the following criteria:\n\nINCLUSION CRITERIA:\n\n1. Men and women over 18 years of age\n2. Indication of a simple extraction\n3. Delivery of signed informed consent\n\nEXCLUSION CRITERIA:\n\n1. Need for multiple extractions\n2. Presence of severe swelling prior to surgery in the extraction area\n3. Regular treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or other anti-inflammatory drugs\n4. Presence of hematologic disease\n5. Previous radiation, chemotherapy, or immunosuppressive treatments\n6. Uncontrolled diabetes mellitus, metabolic bone disease, ongoing treatment with bisphosphonates drugs, or pregnancy'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-05', 'studyFirstSubmitDate': '2022-08-01', 'studyFirstSubmitQcDate': '2022-08-05', 'lastUpdatePostDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ridge dimensions', 'timeFrame': '3 months', 'description': 'assessment of ridge dimensions 3 months after intervention for both groups. At the baseline it was assessed clinically. After 3 months, the flap was released and the ridge width and height were assessed clinically.'}, {'measure': 'Gingival biotype', 'timeFrame': '3 months', 'description': 'assessment of gingival biotype 3 months after intervention according to gingival thickness (using periodontal probe: if \\<1 mm = Thin, while if \\>1 =Thick).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['recurrent', 'Liquid platelet-rich fibrin', 'Advanced platelet-rich fibrin plus', 'ridge preservation'], 'conditions': ['Liquid-PRF', 'A-PRF Plus']}, 'referencesModule': {'references': [{'pmid': '37726689', 'type': 'DERIVED', 'citation': "Lahham C, Ta'a MA, Lahham E, Michael S, Zarif W. The effect of recurrent application of concentrated platelet-rich fibrin inside the extraction socket on the hard and soft tissues. a randomized controlled trial. BMC Oral Health. 2023 Sep 19;23(1):677. doi: 10.1186/s12903-023-03400-5."}]}, 'descriptionModule': {'briefSummary': 'Procedure: Tooth is extracted, then A-PRF+ is placed inside the socket. After that the ridge dimensions is asses clinically at the baseline) in addition to clinical assessment of the gingival biotype at the baseline.\n\nThen patients will be divided into 2 groups:\n\nGroup 1: 50% of patients will have recurrent Liquid-PRF injections inside the extraction socket every 2 weeks (A-PRF+, followed by recurrent Liquid-PRF) Group 2: 50% of patients without recurrent (just A-PRF+) After 3 months from extraction: both groups will be assessed clinically (gingival biotype) \\& (Ridge dimensions) in order to assess the role of recurrent application of Liquid-PRF on these parameters.', 'detailedDescription': "In this study, we will select 20 patients who need a simple tooth extraction, then determine the gingival biotype, take a blood sample to prepare A-PRF+ (centrifugation of the patient's blood for 8 min at 1300 rpm using red caps tubes), then do the extraction. After that, A-PRF+ is prepared and inserted into the extraction socket, and sutured using horizontal mattress suturing technique.\n\nAfter the clinical assessment of the ridge dimensions at the baseline\n\nThen patients will be divided into 2 groups:\n\nGroup 1: 10 patients will have recurrent Liquid-PRF injections inside the extraction socket every 2 weeks (A-PRF+, followed by recurrent Liquid-PRF) Liquid-PRF preparation: Centrifugation of the patient's blood for 8 min at 2500 rpm using white caps tubes.\n\nGroup 2: 10 patients without recurrent application of Liquid-PRF (just A-PRF+) After 3 months from extraction: both groups will be assessed clinically (gingival biotype) \\& (Ridge dimensions) in order to evaluate the effect of recurrent application of Liquid-PRF on these parameters.\n\nAssessment method:\n\nfor Hard tissue evaluation (Bone): we assess the dimensions clinically For soft tissue: we will use a periodontal probe to assess the gingival thickness after giving local anesthesia.\n\n\\---------------------------------------------\n\nSelection Criteria\n\nINCLUSION CRITERIA:\n\n1. Men and women over 18 years of age\n2. Indication of a simple extraction\n3. Delivery of signed informed consent\n\nEXCLUSION CRITERIA:\n\n1. Need for multiple extractions\n2. Presence of severe swelling prior to surgery in the extraction area\n3. Regular treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or other anti-inflammatory drugs\n4. Presence of hematologic disease\n5. Previous radiation, chemotherapy, or immunosuppressive treatments\n6. Uncontrolled diabetes mellitus, metabolic bone disease, ongoing treatment with bisphosphonates drugs, or pregnancy"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Men and women over 18 years of age\n2. Indication of a simple extraction (Non-molar tooth)\n3. Delivery of signed informed consent\n4. Need delayed implant placement in the place of extraction\n\nExclusion Criteria:\n\n1. Need for multiple extractions\n2. Presence of severe swelling prior to surgery in the extraction area\n3. Regular treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or other anti-inflammatory drugs\n4. Presence of hematologic disease\n5. Previous radiation, chemotherapy, or immunosuppressive treatments\n6. Uncontrolled diabetes mellitus, metabolic bone disease, ongoing treatment with bisphosphonates drugs, or pregnancy'}, 'identificationModule': {'nctId': 'NCT05492357', 'acronym': 'Liquid-PRF', 'briefTitle': 'Effects of Recurrent Application of Liquid-PRF on Hard and Soft Tissues', 'organization': {'class': 'OTHER', 'fullName': 'Arab American University (Palestine)'}, 'officialTitle': 'The Effect of Recurrent Application of Liquid Platelet-rich Fibrin in the Extraction Socket on the Hard and Soft Tissues. A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'PHRC/HC/1151/22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Advanced platelet-rich fibrin plus + Liquid platelet-rich fibrin', 'description': "A-PRF plus + Liquid-PRF are prepared from the patient's blood.", 'interventionNames': ['Other: Liquid platelet-rich fibrin', 'Other: Advanced Platelet-rich fibrin plus']}, {'type': 'EXPERIMENTAL', 'label': 'Advanced platelet-rich fibrin plus alone', 'description': "A-PRF+ is prepared from the patient's blood.", 'interventionNames': ['Other: Advanced Platelet-rich fibrin plus']}], 'interventions': [{'name': 'Liquid platelet-rich fibrin', 'type': 'OTHER', 'otherNames': ['Liquid-PRF'], 'description': "Liquid platelet-rich fibrin is prepared from the patient's blood and injected into the extraction socket every two weeks (up to 3 months = Just 4 times of application)", 'armGroupLabels': ['Advanced platelet-rich fibrin plus + Liquid platelet-rich fibrin']}, {'name': 'Advanced Platelet-rich fibrin plus', 'type': 'OTHER', 'description': 'A-PRF+ is placed into the extraction socket immediately after tooth extraction', 'armGroupLabels': ['Advanced platelet-rich fibrin plus + Liquid platelet-rich fibrin', 'Advanced platelet-rich fibrin plus alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00000', 'city': 'Bethlehem', 'country': 'Palestinian Territories', 'facility': 'Cezar Lahham', 'geoPoint': {'lat': 31.70487, 'lon': 35.20376}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cezar Edward Lahham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Cezar Edward Lahham', 'investigatorAffiliation': 'Arab American University (Palestine)'}}}}