Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2025-12-26 @ 11:12 PM
Study NCT ID:
NCT05089812
Status:
COMPLETED
Last Update Posted:
2024-06-27
First Post:
2021-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Platelet-rich Fibrin on Clinical and Patient-centered Outcomes of Third Molar Extractions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'split-mouth study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-26', 'studyFirstSubmitDate': '2021-10-11', 'studyFirstSubmitQcDate': '2021-10-11', 'lastUpdatePostDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Swelling', 'timeFrame': 'Pre-surgical and at day 1, 3, 7 and 14 post-surgical', 'description': 'Buccal swelling will be measured manually as well as within creating a 3D face scan pre-surgical and at day 1, 3, 7 and 14 post-surgical. Scans will be superimposed and compared with Romexis software. Manual measurement: Lines between lateral corner of the eye- jaw angle, Tragus- outer Mouth corner, Tragus-Pogonion will be measured in mm and be compared pre-surgical and at day 1, 3, 7 and 14 post-surgical. longer lines suggest more swelling and a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Change in Inflammatory Complications - Amount of clinical recordings', 'timeFrame': 'Pre-surgical and at day 1, 3, 7 and 14 post-surgical', 'description': 'Clinical recordings of post-surgical inflammatory complications (like issue of purulent matter, restriction of the opening of the mouth, clinical attachment loss of second molar distal, flap closure)'}, {'measure': 'Change in Inflammatory Complications - VAS Swelling', 'timeFrame': 'Pre-surgical and at day 1, 3, 7 and 14 post-surgical', 'description': 'VAS-Scale day 1-7 (Swelling). Scale from 0-10 (0 is no swelling/good outcome, 10 is a very high amount of swelling/bad outcome)'}, {'measure': 'Change in Inflammatory Complications - VAS Bleeding', 'timeFrame': 'Pre-surgical and at day 1, 3, 7 and 14 post-surgical', 'description': 'VAS-Scale day 1-7 (Bleeding) (0 is no bleeding/good outcome, 10 is a very high amount of bleeding/bad outcome)'}, {'measure': 'Change in Inflammatory Complications - VAS Pain', 'timeFrame': 'Pre-surgical and at day 1, 3, 7 and 14 post-surgical', 'description': 'VAS-Scale day 1-7 (pain) (0 is no pain/good outcome, 10 is a very bad pain/bad outcome)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oral Surgery']}, 'referencesModule': {'references': [{'pmid': '39467892', 'type': 'DERIVED', 'citation': 'Zwittnig K, Kirnbauer B, Truschnegg A, Jakse N, Wolf A, Sokolowski A, Mischak I, Payer M. Effectiveness of platelet-rich fibrin in third molar extractions: a randomized controlled split-mouth study. Clin Oral Investig. 2024 Oct 29;28(11):615. doi: 10.1007/s00784-024-06002-9.'}]}, 'descriptionModule': {'briefSummary': 'The fear of oral surgeries is mostly dedicated to pain and swelling in the following days. It is not surprising, that it is of high interest to do anything to reduce these consequences. Maybe this is a reason, why using platelet concentrates in oral health rehabilitation has become common in the last couple of years. Less swelling, less pain, quicker healing. The aims of the present study are to determine the effect of a platelet rich fibrin on postsurgical inflammatory complications and patient-centred outcomes and perceptions, in patients undergoing third molar extractions by split mouth technique.\n\n25 medically healthy adults will be assigned to one of 2 groups (1 test- and 1 control group). This means due to the split mouth technique patients undergo a third molar extraction twice. The first time the patient will be randomly assigned to the test- or control group and the second time the patient will be in the other group (test or control group).\n\nThe test groups socket will be filled with a PRF (platelet-rich fibrin)-Clot before suturing the wound during third molar surgery. As well, a blood count and coagulations values will be determined. The control group will be operated conventionally. Swelling will be measured at day 1, 3 and 7 post surgery by CBCT (cone-beam computed tomography) facial scan. Subjects will be examined clinically by examiners at the seventh day after surgery for postoperative complications. In addition, Visual analogue scores (VAS) on pain, swelling and bleeding will be obtained from the patients from day 0 through day 7. The present study will answer an important clinical question with regards to the recommendation of platelet-rich fibrin usage to prevent post-operative complications with third molar surgery and to recommend a platelet-rich fibrin, if required.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medically healthy adult \\[ASA (American Society of Anesthesiologists) classification I-II\\], age ≥ 16 years old\n* Preferably non-smoker, or previous smoker (quit ≥ 5 years), light smoker with less than 20 cigarettes/ day\n* Therapeutic or strategic indications\n* No allergies against local anasthesia (Articain, Mepivacain) and their preservatives (Natriummetabisulfid E223, natriumchlorid)\n* Written consent of the patient\n* No infected upper and lower third molars\n* Third molars in 4 quadrants and located in maxilla/mandible (classification of Pell and Gregory/ Winter) and indication for extractions\n\nExclusion Criteria:\n\n* Medically compromised subjects (ASA classification III-V)\n* General contraindications against third molar extractions (e.g. immunodeficiency, advanced systemic diseases, corticosteroid medication)\n* Treatment or diseases that may have an effect on bone turnover or bone or non-mineralized tissue metabolism (e.g. Bisphosphonates or local radio-therapy)\n* Patients with anticoagulant therapy\n* Heavy smoker or previous heavy smoker (quit \\< 5 years; ≥ 20 cigarettes/day)\n* Use of any form of antibiotics in the last 3 months or subjects requiring antibiotic prophylaxis prior to dental treatment\n* Pregnant or breast feeding. Self declared intend to conceive. A pregnancy test performed for female patients.\n* Subjects aged \\< 16 years old'}, 'identificationModule': {'nctId': 'NCT05089812', 'acronym': 'PRF', 'briefTitle': 'The Effect of Platelet-rich Fibrin on Clinical and Patient-centered Outcomes of Third Molar Extractions', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'The Effect of Platelet-rich Fibrin on Clinical and Patient-centered Outcomes of Third Molar Extractions', 'orgStudyIdInfo': {'id': 'EK: 33-451 ex 20/21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test-Group', 'description': 'PRF-Group', 'interventionNames': ['Procedure: Third-molar extraction using platelet-rich fibrin as a filling of the alveolus']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control-Group', 'interventionNames': ['Procedure: Third-molar extraction using platelet-rich fibrin as a filling of the alveolus']}], 'interventions': [{'name': 'Third-molar extraction using platelet-rich fibrin as a filling of the alveolus', 'type': 'PROCEDURE', 'description': 'see above', 'armGroupLabels': ['Control-Group', 'Test-Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'state': 'Styra', 'country': 'Austria', 'facility': 'Medical University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}