Temporomandibular Joint Arthrocentesis With Infiltration of PRP + Ropivacaine Versus PRP
Temporomandibular Joint Disorders
About this trial
This is an interventional treatment trial for Temporomandibular Joint Disorders focused on measuring temporomandibular disorders, temporomandibular joint arthrocentesis, ropivacaine, randomized clinical trial
Eligibility Criteria
Inclusion Criteria: Male and female subjects between the ages of 18-99 years; For women of reproductive potential: use of highly effective contraception for at least 1 month prior to the first visit and agreement to use such a method during participation in the study; In the opinion of the investigator, the subject is capable of understanding and comprehending the study in question; The subject signs the written informed consent form and provides the necessary privacy clearance prior to the start of any study procedures; Patients with TMD with an indication for TMJ arthrocentesis: clinical and imaging diagnosis of unilateral or bilateral intra-articular disorder; Magnetic resonance imaging (MRI) assessing the intra-articular derangement; Radiological findings that most components of the joint were salvageable; Dimitroulis classification between 2 and 3. Exclusion Criteria: Subject has had other previous minimally invasive or invasive treatment for TMD; Subject has any contraindication to the use of ropivacaine according to the Ropivacaine (Fresenius Kabi) bulletin; Subject has a history of allergy to any drug in the study; Subject taking analgesic medication prior to treatment for other conditions; The subject has an inability to interpret pain scales or to read and interpret the study's target questionnaire; Women who are pregnant or breastfeeding. For women of reproductive potential, use of highly effective contraception for at least 1 month prior to the first visit is required (Combined oral contraceptive pill, vaginal ring, male and female condom, intrauterine device, diaphragm, injectable hormonal contraceptive) and agreement to use such a method during study participation. Subjects under 18 and over 99 years old; Subjects diagnosed with the following conditions cannot participate in the study: cardiovascular disorders, peripheral vascular disease, arrhythmias, auriculoventricular conduction disorders, heart failure; hypotension, epileptic patients, patients with liver and kidney disease, patients with porphyria, patients with acidosis. Subjects with severe medical problems and mental illness.
Sites / Locations
- Instituto Português da Face
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
Placebo Group: PRP
PRP + Ropivacaine
Temporomandibular joint arthrocentesis, Ringer lactate for washing, and 1ml PRP infiltration in each temporomandibular joint
Temporomandibular joint arthrocentesis, Ringer lactate for washing, and 1ml PRP + ropivacaine infiltration in each temporomandibular joint