Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-02-28 @ 12:02 AM
Study NCT ID:
NCT03672669
Status:
COMPLETED
Last Update Posted:
2018-09-14
First Post:
2018-09-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Effect of A-PRF and L-PRF on Outcomes After Removal of Impacted Mandibular Third Molar
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D014313', 'term': 'Trismus'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013035', 'term': 'Spasm'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007958', 'term': 'Leukocyte Count'}], 'ancestors': [{'id': 'D001772', 'term': 'Blood Cell Count'}, {'id': 'D002452', 'term': 'Cell Count'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006403', 'term': 'Hematologic Tests'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D002468', 'term': 'Cell Physiological Phenomena'}, {'id': 'D001790', 'term': 'Blood Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'patients with bilateral impacted mandibular third molar which surgically operated at different times'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-13', 'studyFirstSubmitDate': '2018-09-11', 'studyFirstSubmitQcDate': '2018-09-13', 'lastUpdatePostDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Scores Evaluted', 'timeFrame': '1st day after the operation.', 'description': 'For the postoperative period, the pain scores change was evaluated with the help of the visual analog scale (VAS) ranging from 0 (no pain) to 10 (most severe pain).'}, {'measure': 'Pain Scores Evaluted', 'timeFrame': '2nd day after the operation.', 'description': 'For the postoperative period, the pain scores change was evaluated with the help of the visual analog scale (VAS) ranging from 0 (no pain) to 10 (most severe pain).'}, {'measure': 'Pain Scores Evaluted', 'timeFrame': '3rd day after the operation.', 'description': 'For the postoperative period, the pain scores change was evaluated with the help of the visual analog scale (VAS) ranging from 0 (no pain) to 10 (most severe pain).'}, {'measure': 'Pain Scores Evaluted', 'timeFrame': '7th day after the operation.', 'description': 'For the postoperative period, the pain scores change was evaluated with the help of the visual analog scale (VAS) ranging from 0 (no pain) to 10 (most severe pain).'}], 'secondaryOutcomes': [{'measure': 'Number of Analgesics Taken by the Patients', 'timeFrame': 'Each patient was evaluated on the 1st, 2nd, 3rd, and 7th days after the operation.'}, {'measure': 'Trismus', 'timeFrame': 'Each patient was evaluated in order to obtain measurements on the 1st, 2nd, 3rd, and 7th days after the operation.', 'description': 'Trismus was assessed by measuring the distance between the mesioincisal corner of the maxillary and mandibular right incisors while mouth was fully opened'}, {'measure': 'Swelling on the cheek', 'timeFrame': 'Each patient was evaluated in order to obtain measurements on the 1st, 2nd, 3rd, and 7th days after the operation.', 'description': 'In order to record swelling, a modification of the tape measurement method'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Leukocyte- and platelet rich fibrin', 'Advanced platelet rich fibrin', 'Impacted mandibular third molar surgery'], 'conditions': ['Pain, Postoperative', 'Trismus', 'Swelling']}, 'descriptionModule': {'briefSummary': 'In this study, it was aimed to investigating and comparing the postoperative effects of leukocyte- and platelet-rich fibrin (L-PRF) and advanced platelet-rich fibrin (A-PRF) in terms of pain, swelling on the cheek, and trismus after mandibular third molar surgery. The study included a total of 27 patients with bilateral impacted mandibular third molar which surgically operated at different times. Patients were evaluated in two randomly separated groups. For the first group; A-PRF and for the second group; L-PRF was applied into the tooth socket. The outcomes variables were; pain, swelling, the number of analgesics taken, and trismus. These variables were also assessed on the basis of; 1st, 2nd, 3rd and 7th days following the operation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '26 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age≥18\n* the presence of bilaterally symmetrically impacted mandibular third molar, which requires an extraction for prophylactic reasons\n* absence of systemic diseases\n* absence of chronic opioid taken;\n* not being pregnant\n* not smoking and no alcohol usage\n* the absence of allergy to penicillin or any other drugs used during standardized postoperative therapy.\n\nExclusion Criteria:\n\n* tooth needed to be sectioning during the operation\n* operation time exceeding 30 minutes\n* the cases with severe periodontal disease or acute pericoronitis,\n* the cases using antibiotics for an existing infection\n* the cases not capable of following postoperative instructions'}, 'identificationModule': {'nctId': 'NCT03672669', 'briefTitle': 'Comparison of the Effect of A-PRF and L-PRF on Outcomes After Removal of Impacted Mandibular Third Molar', 'organization': {'class': 'OTHER', 'fullName': 'Near East University, Turkey'}, 'officialTitle': 'Comparison of the Effect of Advanced Platelet-rich Fibrin and Leukocyte- and Platelet-rich Fibrin on Outcomes After Removal of Impacted Mandibular Third Molar: A Randomised Split-mouth Study', 'orgStudyIdInfo': {'id': 'Near East University'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Advanced Platelet Rich Fibrin (A-PRF)', 'description': 'A-PRF was applied into the tooth socket after mandibular third molar surgery.', 'interventionNames': ['Genetic: Advanced Platelet Rich Fibrin (A-PRF)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Leukocyte- and platelet-rich fibrin (L-PRF)', 'description': 'L-PRF was applied into the tooth socket after mandibular third molar surgery.', 'interventionNames': ['Genetic: Leukocyte- and platelet-rich fibrin (L-PRF)']}], 'interventions': [{'name': 'Advanced Platelet Rich Fibrin (A-PRF)', 'type': 'GENETIC', 'description': 'blood samples collected in 10 ml of vacuumed plain glass tubes were centrifuged for 14 minutes at 1500 rpm without anticoagulant agents in order to obtain A-PRF', 'armGroupLabels': ['Advanced Platelet Rich Fibrin (A-PRF)']}, {'name': 'Leukocyte- and platelet-rich fibrin (L-PRF)', 'type': 'GENETIC', 'description': 'blood samples collected in 10 ml of glass coated plastic tubes were centrifuged without anticoagulant agents for 10 minutes in order to obtain L-PRF', 'armGroupLabels': ['Leukocyte- and platelet-rich fibrin (L-PRF)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '99138', 'city': 'Mersin', 'country': 'Turkey (Türkiye)', 'facility': 'Near East University', 'geoPoint': {'lat': 36.81196, 'lon': 34.63886}}], 'overallOfficials': [{'name': 'Mehmet G Caymaz, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Near East University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Near East University, Turkey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Mehmet Gagari Caymaz', 'investigatorAffiliation': 'Near East University, Turkey'}}}}