Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-01-01 @ 12:16 AM
Study NCT ID:
NCT06900894
Status:
COMPLETED
Last Update Posted:
2025-04-02
First Post:
2025-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Platelet-Rich Fibrin and Kinesio Taping on Postoperative Recovery in Oral Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study follows a parallel assignment model in which participants are randomly allocated into three groups: Platelet-Rich Fibrin (PRF), Kinesio Taping, and Control. Each group receives a distinct intervention to evaluate the effectiveness of these non-pharmacological approaches in managing postoperative pain, edema, and recovery following impacted third molar surgery.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-28', 'studyFirstSubmitDate': '2025-03-17', 'studyFirstSubmitQcDate': '2025-03-22', 'lastUpdatePostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Pain Assessment (NRS)', 'timeFrame': 'Preoperative day 1, postoperative days 3 and 7', 'description': 'The pain intensity of the patients will be assessed using the Numerical Rating Scale (NRS) on preoperative day 1 and postoperative days 3 and 7.\n\nOn this scale: 0 indicates no pain, 10 indicates the worst imaginable pain. Before the procedure, patients were informed about the scale and instructed to rate their pain intensity accordingly.'}, {'measure': 'Postoperative Facial Swelling Assessment', 'timeFrame': 'Preoperative day 1, postoperative days 3 and 7', 'description': 'Swelling will be evaluated using anthropometric measurement techniques on preoperative (surgery day), postoperative days 1, 3, and 7.\n\nMeasurement methods:\n\nLateral canthus-gonion distance (distance from the outer corner of the eye to the mandibular angle) Commissure-tragus distance (distance from the oral commissure to the midpoint of the tragus) All measurements were performed using a flexible ruler, and the results were recorded in millimeters.'}, {'measure': 'Oral Health Impact Profile-14 (OHIP-14) Score', 'timeFrame': 'Postoperative days 3 and 7', 'description': "The quality of life of the patients will be assessed using the OHIP-14 questionnaire on postoperative days 3 and 7.\n\nOHIP-14 consists of 14 standardized items, each rated on a scale from 0 to 4. Total scores range from 0 to 56, with higher scores indicating worse quality of life.\n\nThis scale was used to evaluate the impact of postoperative complications on patients' quality of life."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Impacted third molar', 'elastic bandage', 'platelet-rich fibrin', 'postoperative pain', 'quality of life', 'Postoperative Edema'], 'conditions': ['Impacted Third Molar Tooth', 'Postoperative Pain', 'Postoperative Edema']}, 'descriptionModule': {'briefSummary': 'This study investigates the effectiveness of Platelet-Rich Fibrin (PRF) and Kinesio Taping in reducing postoperative pain, edema, and improving recovery following impacted third molar surgery. A prospective, randomized clinical trial was conducted with 44 patients aged 18-35 years. Patients were assigned to three groups: (1) PRF applied locally to the extraction socket, (2) Kinesio Taping applied postoperatively and removed on the third day, and (3) a control group receiving standard postoperative care. Postoperative outcomes were assessed on days 3 and 7, including pain levels, edema, and quality of life. This study aims to evaluate PRF and Kinesio Taping as non-pharmacological adjuncts in oral and maxillofacial surgery.', 'detailedDescription': 'This study investigates the effectiveness of Platelet-Rich Fibrin (PRF) and Kinesio Taping in postoperative management following impacted mandibular third molar surgery. Postoperative complications, such as pain and edema, are commonly observed and may impact patient comfort and recovery. This study aims to evaluate the feasibility of two non-pharmacological approaches-PRF and Kinesio Taping (Elastic Bandaging)-in postoperative care.\n\nA total of 44 patients aged 18-35 years participated in this prospective, randomized clinical trial. Patients were assigned to one of three groups:\n\nPRF Group: Platelet-rich fibrin (PRF) was applied locally into the extraction socket.\n\nKinesio Taping Group: An elastic bandage was applied postoperatively to the surgical area and removed on the third day.\n\nControl Group: Standard postoperative care was provided with no additional intervention.\n\nPostoperative evaluations were conducted on the 3rd and 7th days. The measured parameters included:\n\nEdema: Measured using anthropometric techniques.\n\nPain: Assessed with the Numerical Rating Scale (NRS).\n\nQuality of Life: Evaluated using the Oral Health Impact Profile-14 (OHIP-14).\n\nThis study aims to assess the feasibility of PRF and Kinesio Taping in postoperative management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 18-35 years\n* Systemically healthy individuals\n* Non-smokers\n* No psychological disorders\n* Preoperative pain level between 0-3 on the Numerical Rating Scale (NRS)\n* No preoperative edema in the surgical area\n* Impacted mandibular third molars classified as Class 1 or 2, Level B, and mesioangular according to the Pell-Gregory classification\n* Signed an informed consent form\n\nExclusion Criteria:\n\n* Under 18 or over 35 years old\n* Presence of chronic or systemic diseases\n* Pregnant or breastfeeding patients\n* Surgical duration exceeding 45 minutes\n* Smokers\n* Patients requiring prophylactic antibiotics due to systemic health conditions\n* Patients who did not meet the study criteria or did not sign the informed consent form'}, 'identificationModule': {'nctId': 'NCT06900894', 'acronym': 'PRFKTOralSur', 'briefTitle': 'Effects of Platelet-Rich Fibrin and Kinesio Taping on Postoperative Recovery in Oral Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Mustafa Kemal University'}, 'officialTitle': 'Effectiveness of Platelet-Rich Fibrin and Elastic Bandaging on Postoperative Pain, Edema, and Recovery Following Impacted Molar Surgery: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'PRF_KT2025'}, 'secondaryIdInfos': [{'id': 'Ethics Committee No.', 'type': 'REGISTRY', 'domain': 'Hatay Clinical Research Ethics Committee - 2023/03'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRF Group', 'description': 'Participants in this group received Platelet-Rich Fibrin (PRF) applied to the extraction socket following impacted third molar surgery. PRF was prepared using a centrifugation protocol and placed into the surgical site.', 'interventionNames': ['Biological: Platelet-Rich Fibrin (PRF)']}, {'type': 'EXPERIMENTAL', 'label': 'Kinesio Taping Group', 'description': 'Participants in this group received Kinesio Taping applied postoperatively. The elastic therapeutic tape was applied to the masseter and submandibular region following a standardized taping protocol.', 'interventionNames': ['Device: Kinesio Taping']}, {'type': 'OTHER', 'label': 'Control Group', 'description': 'Participants in this group received standard postoperative care, including routine pain management and wound care, without additional interventions.', 'interventionNames': ['Other: Standard Postoperative Care']}], 'interventions': [{'name': 'Platelet-Rich Fibrin (PRF)', 'type': 'BIOLOGICAL', 'description': 'PRF was prepared using a centrifugation protocol and applied to the extraction socket.', 'armGroupLabels': ['PRF Group']}, {'name': 'Kinesio Taping', 'type': 'DEVICE', 'description': 'Kinesio Tape was applied postoperatively to the masseter and submandibular region.', 'armGroupLabels': ['Kinesio Taping Group']}, {'name': 'Standard Postoperative Care', 'type': 'OTHER', 'description': 'Patients in the control group received standard postoperative care.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31001', 'city': 'Hatay', 'country': 'Turkey (Türkiye)', 'facility': 'Hatay Mustafa Kemal University, Faculty of Dentistry', 'geoPoint': {'lat': 38.40227, 'lon': 27.10486}}], 'overallOfficials': [{'name': 'züleyha başar karakuzu, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mustafa Kemal University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The individual participant data (IPD) collected during the study will not be shared due to confidentiality and ethical considerations. Data will only be used for statistical analysis and publication purposes in an aggregated and anonymized form.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mustafa Kemal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DDS, Oral and Maxillofacial Surgeon', 'investigatorFullName': 'züleyha başar karakuzu', 'investigatorAffiliation': 'Mustafa Kemal University'}}}}