Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-27 @ 4:48 AM
Study NCT ID:
NCT04317560
Status:
UNKNOWN
Last Update Posted:
2020-03-23
First Post:
2020-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation Of Efficacy Of Liquid Platelet Rich Fibrin In Temporomandibular Joint Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013705', 'term': 'Temporomandibular Joint Disorders'}], 'ancestors': [{'id': 'D017271', 'term': 'Craniomandibular Disorders'}, {'id': 'D008336', 'term': 'Mandibular Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069237', 'term': 'Arthrocentesis'}], 'ancestors': [{'id': 'D019152', 'term': 'Paracentesis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-19', 'studyFirstSubmitDate': '2020-03-03', 'studyFirstSubmitQcDate': '2020-03-19', 'lastUpdatePostDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Helkimo Clinical Dysfunction Score improvement over time', 'timeFrame': 'operation time, tenth day, end of first month, end of third month', 'description': 'In the Helkimo Clinical Dysfunction Index, the maximum mandibular movement limits are measured vertically and laterally. In addition, TMJ function, muscle pain, TMJ region pain and mandibular motion pain are evaluated separately. After all these evaluations, all the scores given are summed up and a total dysfunction score is obtained. If this total score is 0, the dysfunction is completely healed. If the total score is between 1 and 4, mild dysfunction, between 5 and 9, moderate dysfunction, and between 10 and 25 severe dysfunction.\n\nSince lower scores represent better health, the amount of improvement between sessionsis calculated by subtracting the next score from the previous score.'}, {'measure': 'Visual Analog Scale improvement over time', 'timeFrame': 'operation time, tenth day, end of first month, end of third month', 'description': "The patient gives his pain a value between 0-10. The patients' pain scores were recorded by using a 10 cm visual analog scale (VAS) from 0, which represents no pain, to 10, which represents the worst possible pain.\n\nSince lower scores represent better health, the amount of improvement between sessionsis calculated by subtracting the next score from the previous score."}, {'measure': 'Maximum incisal opening improvement over time', 'timeFrame': 'operation time, tenth day, end of first month, end of third month', 'description': 'It is the vertical distance between the incisal teeth when the patient opens his mouth to the maximum. It is measured with the help of a caliper.\n\nSince higher scores represent better health, the amount of improvement between sessionsis calculated by subtracting the previous score from the next score.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Liquid Platelet Rich Fibrin', 'Temporomandibular Joint Disorders', 'Wilkes classification'], 'conditions': ['Temporomandibular Joint Disorders']}, 'referencesModule': {'references': [{'pmid': '30231809', 'type': 'BACKGROUND', 'citation': 'Albilia J DMD, MSc, Herrera-Vizcaino C DDS, Weisleder H BSc, Choukroun J MD, Ghanaati S MD, DMD, PhD. Liquid platelet-rich fibrin injections as a treatment adjunct for painful temporomandibular joints: preliminary results. Cranio. 2020 Sep;38(5):292-304. doi: 10.1080/08869634.2018.1516183. Epub 2018 Sep 20.'}, {'pmid': '25157351', 'type': 'BACKGROUND', 'citation': 'Pihut M, Szuta M, Ferendiuk E, Zenczak-Wieckiewicz D. Evaluation of pain regression in patients with temporomandibular dysfunction treated by intra-articular platelet-rich plasma injections: a preliminary report. Biomed Res Int. 2014;2014:132369. doi: 10.1155/2014/132369. Epub 2014 Aug 3.'}, {'pmid': '9216503', 'type': 'BACKGROUND', 'citation': 'Zardeneta G, Milam SB, Schmitz JP. Elution of proteins by continuous temporomandibular joint arthrocentesis. J Oral Maxillofac Surg. 1997 Jul;55(7):709-16; discussion 716-7. doi: 10.1016/s0278-2391(97)90583-8.'}, {'pmid': '4524733', 'type': 'BACKGROUND', 'citation': 'Helkimo M. Studies on function and dysfunction of the masticatory system. II. Index for anamnestic and clinical dysfunction and occlusal state. Sven Tandlak Tidskr. 1974 Mar;67(2):101-21. No abstract available.'}, {'pmid': '9024352', 'type': 'BACKGROUND', 'citation': 'Nitzan DW, Samson B, Better H. Long-term outcome of arthrocentesis for sudden-onset, persistent, severe closed lock of the temporomandibular joint. J Oral Maxillofac Surg. 1997 Feb;55(2):151-7; discussion 157-8. doi: 10.1016/s0278-2391(97)90233-0.'}]}, 'descriptionModule': {'briefSummary': 'This randomized clinical trial aims to evaluate the efficacy of liquid platelet-rich fibrin administration at different Wilkes stages.', 'detailedDescription': "Thirty six patients with unilateral painful internal derangement (ID) (Wilkes' 3-4-5) were included. Patients were divided into 2 groups. In group 1 were treated with only artrosythesis. In group 2 were treated with artrosythesis and liquid platelet rich fibrin. In group 2, patients were injected with 1.5-2cc of liquid platelet-rich fibrin within the superior joint space at operation day. Pain and subjective dysfunction were recorded using a visual analog scale and Helkimo index at operation day and tenth day, one month later and 3 months later."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Unilateral internal temporomandibular disorder\n* localized temporomandibular joint pain\n* Scoring 3 and above in Wilke's classification.\n\nExclusion Criteria:\n\n* Autoimmune diseases\n* Significant mechanical obstruction that prevents mouth opening\n* Acute capsulitis,\n* Benign or malignant temporomandibular joint lesions\n* Neurological disorders,\n* Blood diseases and coagulation disorders\n* Patients with a history of allergies or anaphylactic shock."}, 'identificationModule': {'nctId': 'NCT04317560', 'briefTitle': 'Evaluation Of Efficacy Of Liquid Platelet Rich Fibrin In Temporomandibular Joint Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Aydin Adnan Menderes University'}, 'officialTitle': 'Evaluation Of The Clinical Efficacy Of Liquid Platelet Rich Fibrin Application In Painful Temporomandibular Joint Disorders', 'orgStudyIdInfo': {'id': '2018-049'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arthrocentesis', 'description': "2 guiding points have been created on the skin. The first one is 10 mm in front of the tragus and 2 mm below the tragus line. The second guide point is on the same line, 20 mm in front of the tragus and 6 mm below. After the auriculotemporal nerve block was made, the first 20 gauge needle was inserted from the first point. 2mL Ringer's Lactate solution is injected into the temporomandibular joint area, and then a second 20 gauge needle is entered from the second guide point determined before and pressurized washing is performed with 100 mL of 5% lactate solution to enter the first needle and exit from the second needle.", 'interventionNames': ['Procedure: Arthrocentesis']}, {'type': 'EXPERIMENTAL', 'label': 'Arthrocentesis plus i-PRF injection', 'description': '2 tubes of blood were collected from the patients with the help of vacuumed 10 mL special liquid PRF tubes (Choukroun I-PRF Collection Tubes, Dr. Choukroun) after arthrocentesis. Blood tubes were centrifuged at 700rpm for 3 minutes. 3 mL of liquid PRF was obtained at the top of each tube. Only the second needle was removed without removing the first needle inserted. I-PRF was injected into the joint areas of all patients in the experimental group, with a maximum dose of 2 mL per joint.', 'interventionNames': ['Procedure: Arthrocentesis', 'Procedure: injectable platelet rich fibrin injection']}], 'interventions': [{'name': 'Arthrocentesis', 'type': 'PROCEDURE', 'description': "2 guiding points have been created on the skin. The first one is 10 mm in front of the tragus and 2 mm below the tragus line. The second guide point is on the same line, 20 mm in front of the tragus and 6 mm below. After the auriculotemporal nerve block was made, the first 20 gauge needle was inserted from the first point. 2mL Ringer's Lactate solution is injected into the temporomandibular joint area, and then a second 20 gauge needle is entered from the second guide point determined before and pressurized washing is performed with 100 mL of 5% lactate solution to enter the first needle and exit from the second needle.", 'armGroupLabels': ['Arthrocentesis', 'Arthrocentesis plus i-PRF injection']}, {'name': 'injectable platelet rich fibrin injection', 'type': 'PROCEDURE', 'description': '2 tubes of blood were collected from the patients with the help of vacuumed 10 mL special liquid PRF tubes (Choukroun I-PRF Collection Tubes, Dr. Choukroun) after arthrocentesis. Blood tubes were centrifuged at 700rpm for 3 minutes. 3 mL of liquid PRF was obtained at the top of each tube. I-PRF was injected into the joint areas of all patients in the experimental group, with a maximum dose of 2 mL per joint.', 'armGroupLabels': ['Arthrocentesis plus i-PRF injection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aydin', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Burcu Gürsoytrak', 'role': 'CONTACT', 'email': 'dt_burcupoyraz@hotmail.com', 'phone': '0505 5628541'}], 'facility': 'Aydın Adnan Menderes University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery', 'geoPoint': {'lat': 37.84501, 'lon': 27.83963}}], 'centralContacts': [{'name': 'Burcu GURSOYTRAK', 'role': 'CONTACT', 'email': 'dt_burcupoyraz@hotmail.com', 'phone': '+902562133939'}, {'name': 'Uğur KARADAYI', 'role': 'CONTACT', 'email': 'dtkaradayi@gmail.com', 'phone': '+905555976270'}], 'overallOfficials': [{'name': 'Burcu GURSOYTRAK', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aydin Adnan Menderes University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aydin Adnan Menderes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Burcu Gürsoytrak', 'investigatorAffiliation': 'Aydin Adnan Menderes University'}}}}