Clinical trial NCT04317560: Evaluation Of Efficacy Of Liquid Platelet Rich Fibrin In Temporomandibular Joint Disorders
Official title: Evaluation Of The Clinical Efficacy Of Liquid Platelet Rich Fibrin Application In Painful Temporomandibular Joint Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Temporomandibular Joint Disorders
Keywords: Liquid Platelet Rich Fibrin
Temporomandibular Joint Disorders
Wilkes classification
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2020-03-23
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized clinical trial aims to evaluate the efficacy of liquid platelet-rich fibrin administration at different Wilkes stages.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Unilateral internal temporomandibular disorder
* localized temporomandibular joint pain
* Scoring 3 and above in Wilke's classification.

Exclusion Criteria:

* Autoimmune diseases
* Significant mechanical obstruction that prevents mouth opening
* Acute capsulitis,
* Benign or malignant temporomandibular joint lesions
* Neurological disorders,
* Blood diseases and coagulation disorders
* Patients with a history of allergies or anaphylactic shock.

Primary outcomes:
measure: Helkimo Clinical Dysfunction Score improvement over time
timeFrame: operation time, tenth day, end of first month, end of third month
measure: Visual Analog Scale improvement over time
timeFrame: operation time, tenth day, end of first month, end of third month
measure: Maximum incisal opening improvement over time
timeFrame: operation time, tenth day, end of first month, end of third month
Secondary outcomes:
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Aydın Adnan Menderes University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery
Study officials:
affiliation: Aydin Adnan Menderes University
name: Burcu GURSOYTRAK
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.