Temporomandibular Joint Arthrocentesis With Infiltration of PRP + Ropivacaine Versus PRP
- Conditions
- Temporomandibular Joint Disorders
- Interventions
- Procedure: temporomandibular joint arthrocentesisDrug: PRP injectionDrug: Ringer's Lactate solution
- Registration Number
- NCT05817162
- Lead Sponsor
- Instituto Portugues da Face
- Brief Summary
The infiltration of Platelet Rich Plasma (PRP) at the end of Temporomandibular Joint (TMJ) arthrocentesis is already an established procedure in the treatment of Temporomandibular Disorders (TMD). Arthrocentesis is a minimally invasive surgical procedure, which aims to eliminate the inflammatory mediators from the inside of the TMJ. PRP is an autologous concentrate of platelets and growth factors, derived from centrifugated blood. Several studies have described the benefits of PRP: it enhances wound healing because of the presence of cytokines and growth factors, and is also stimulates chondrocytes to biosynthesis of collagen. Ropivacaine is a local anesthetic that has been synthesized for use in infiltration anesthesia and to produce both peripheral and central block. Unlike one of its analogues, Bupivacaine, Ropivacaine anesthetize the sensory fibers without affecting the motor ones. The main goal of this investigation is to test the benefits of adding Ropivacaine to the infiltration of PRP in patients submitted to TMJ arthrocentesis.
- Detailed Description
To investigate the potential reduction of pain in the postoperative week in patients submitted to temporomandibular joint double portal arthrocentesis with lavage and Platelet Rich Plasma (PRP) the authors designed a double-blind randomized clinical trial, comparing a treatment group with additional ropivacaine and a control group without ropivacaine.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Group: PRP temporomandibular joint arthrocentesis Temporomandibular joint arthrocentesis, Ringer lactate for washing, and 1ml PRP infiltration in each temporomandibular joint Placebo Group: PRP PRP injection Temporomandibular joint arthrocentesis, Ringer lactate for washing, and 1ml PRP infiltration in each temporomandibular joint Placebo Group: PRP Ringer's Lactate solution Temporomandibular joint arthrocentesis, Ringer lactate for washing, and 1ml PRP infiltration in each temporomandibular joint PRP + Ropivacaine Ropivacaine injection Temporomandibular joint arthrocentesis, Ringer lactate for washing, and 1ml PRP + ropivacaine infiltration in each temporomandibular joint PRP + Ropivacaine temporomandibular joint arthrocentesis Temporomandibular joint arthrocentesis, Ringer lactate for washing, and 1ml PRP + ropivacaine infiltration in each temporomandibular joint PRP + Ropivacaine PRP injection Temporomandibular joint arthrocentesis, Ringer lactate for washing, and 1ml PRP + ropivacaine infiltration in each temporomandibular joint PRP + Ropivacaine Ringer's Lactate solution Temporomandibular joint arthrocentesis, Ringer lactate for washing, and 1ml PRP + ropivacaine infiltration in each temporomandibular joint
- Primary Outcome Measures
Name Time Method TMJ Pain In the first week at a consultation after injection and TMJ arthrocentesis Change in TMJ pain in a 0-10 scale (where 0 is no pain and 10 is the maximum possible pain) assessed by the surgeon
- Secondary Outcome Measures
Name Time Method Postoperative pain Daily 1 week after TMJ arthrocentesis and infiltration Change in TMJ pain / TMJ muscles pain: measured by the patient using a Visual Analogue scale (VAS), with a range from 0 to 10, with 0 being no pain and 10 having maximum unbearable pain. VAS score will be measured every day before TMJ arthrocentesis in the week after surgery.
Myalgia degree assessed by the physiotherapist 1 week after injection and TMJ arthrocentesis in a physiotherapy consultation Myalgia degree in right and left masseter and temporalis muscles evaluated by the physiotherapist in a 0-3 scale
General state pre vs post Daily 1 week after TMJ arthrocentesis and infiltration Daily questionnaire based (OHIP 10) furnished by surgeon to fill at home: the patient has to fill it every day for 1 week. (0-much better, 1-litte better, 2-no changes, 3-litter worse, 4-much worse)
Interrupt meals Daily 1 week after TMJ arthrocentesis and infiltration Daily questionnaire based (OHIP 10) furnished by surgeon to fill at home: the patient has to fill it every day for 1 week (0-never, 1-hardly never, 2-occasionally, 3-fairy often, 4-very often)
Need of medication after intervention Daily 1 week after TMJ arthrocentesis and infiltration Indication of the number of SOS analgesic pills taken each day
TMJ pain during lateral deviation assessed by the physiotherapist 1 week after injection and TMJ arthrocentesis in a physiotherapy consultation Pain in left and right TMJ during lateral deviation evaluated by the physiotherapist in a 0-10 scale (where 0 is no pain and 10 is the maximum possible pain)
TMJ pain during protrusion assessed by the physiotherapist 1 week after injection and TMJ arthrocentesis in a physiotherapy consultation TMJ pain during protrusion evaluated by the physiotherapist in a 0-10 scale (where 0 is no pain and 10 is the maximum possible pain)
Functional limitation chewing foods Daily 1 week after TMJ arthrocentesis and infiltration Daily questionnaire based (OHIP 10) furnished by surgeon to fill at home: the patient has to fill it every day for 1 week (0-never, 1-hardly never, 2-occasionally, 3-fairy often, 4-very often)
Difficult doing usual jobs Daily 1 week after TMJ arthrocentesis and infiltration Daily questionnaire based (OHIP 10) furnished by surgeon to fill at home: the patient has to fill it every day for 1 week (0-never, 1-hardly never, 2-occasionally, 3-fairy often, 4-very often)
Difficulty closing and mouth opening Daily 1 week after TMJ arthrocentesis and infiltration Daily questionnaire based (OHIP 10) furnished by surgeon to fill at home: the patient has to fill it every day for 1 week (0-never, 1-hardly never, 2-occasionally, 3-fairy often, 4-very often)
TMJ pain, muscular pain, ear pain Daily 1 week after TMJ arthrocentesis and infiltration Daily questionnaire based (OHIP 10) furnished by surgeon to fill at home: the patient has to fill it every day for 1 week (0-never, 1-hardly never, 2-occasionally, 3-fairy often, 4-very often)
Sleep been interrupted Daily 1 week after TMJ arthrocentesis and infiltration Daily questionnaire based (OHIP 10) furnished by surgeon to fill at home: the patient has to fill it every day for 1 week (0-never, 1-hardly never, 2-occasionally, 3-fairy often, 4-very often)
Unable to work full capacity Daily 1 week after TMJ arthrocentesis and infiltration Daily questionnaire based (OHIP 10) furnished by surgeon to fill at home: the patient has to fill it every day for 1 week (0-never, 1-hardly never, 2-occasionally, 3-fairy often, 4-very often)
Physiotherapist's perception of comfort during the consultation 1 week after injection and TMJ arthrocentesis in a physiotherapy consultation For the therapist: in a 0 to 10 scale evaluate your perception of patients comfort during the physical therapy question
Difficult to relax Daily 1 week after TMJ arthrocentesis and infiltration Daily questionnaire based (OHIP 10) furnished by surgeon to fill at home: the patient has to fill it every day for 1 week (0-never, 1-hardly never, 2-occasionally, 3-fairy often, 4-very often)
TMJ pain assessed by the physiotherapist 1 week after injection and TMJ arthrocentesis in a physiotherapy consultation Pain in left and right TMJ evaluated by the physiotherapist in a 0-10 scale (where 0 is no pain and 10 is the maximum possible pain)
Trial Locations
- Locations (1)
Instituto Português da Face
🇵🇹Lisboa, Portugal