Temporomandibular Joint Arthrocentesis With Infiltration of PRP + Ropivacaine Versus PRP

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Temporomandibular Joint Arthrocentesis With Infiltration of PRP + Ropivacaine Versus PRP: Does It Reduce Postoperative Pain?

Conditions
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Temporomandibular Joint Disorders

Intervention / Treatment
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* Drug: Ropivacaine injection
* Procedure: temporomandibular joint arthrocentesis
* Drug: PRP injection
* Drug: Ringer's Lactate solution


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: For this randomized clinical trial an appropriate number of sealed envelopes will be prepared: 15 for PRP and 15 for PRP + Ropivacaine. Patients with inclusion criteria will be seen in an orofacial pain session and assessed for pain using the VAS scale, by scoring the degree of pain between 0 (absence of pain) and 10 (maximum pain). Then the patients are proposed for TMJ arthrocentesis.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Group: PRP<br>Temporomandibular joint arthrocentesis, Ringer lactate for washing, and 1ml PRP infiltration in each temporomandibular joint | Procedure: temporomandibular joint arthrocentesis<br>* Temporomandibular arthrocentesis is a minimally invasive surgical procedure, which aims to eliminate the inflammatory mediators from the inside of the TMJ.<br>Drug: PRP injection<br>* Platelet-Rich Plasma (PRP) is an orthobiological adjuvant treatment. PRP has properties to restore intra-articular hyaluronic acid, increases glycosaminoglycan chondrocyte synthesis and balances joint angiogenesis. It is often used as a viscosupplement in TMJ arthrocentesis<br>Drug: Ringer's Lactate solution<br>* Ringers lactate solution is used during arthrocentesis to wash out the joint inflammatory cells and to release the stuck disc phenomenon.<br>|
| Active Comparator: PRP + Ropivacaine<br>Temporomandibular joint arthrocentesis, Ringer lactate for washing, and 1ml PRP + ropivacaine infiltration in each temporomandibular joint | Drug: Ropivacaine injection<br>* 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 without affecting the motor ones. Ropivacaine comes as solution for injection.<br>Procedure: temporomandibular joint arthrocentesis<br>* Temporomandibular arthrocentesis is a minimally invasive surgical procedure, which aims to eliminate the inflammatory mediators from the inside of the TMJ.<br>Drug: PRP injection<br>* Platelet-Rich Plasma (PRP) is an orthobiological adjuvant treatment. PRP has properties to restore intra-articular hyaluronic acid, increases glycosaminoglycan chondrocyte synthesis and balances joint angiogenesis. It is often used as a viscosupplement in TMJ arthrocentesis<br>Drug: Ringer's Lactate solution<br>* Ringers lactate solution is used during arthrocentesis to wash out the joint inflammatory cells and to release the stuck disc phenomenon.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TMJ Pain | 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 | In the first week at a consultation after injection and TMJ arthrocentesis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | 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. | Daily 1 week after TMJ arthrocentesis and infiltration | 
| General state pre vs post | 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) | Daily 1 week after TMJ arthrocentesis and infiltration | 
| Functional limitation chewing foods | 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) | Daily 1 week after TMJ arthrocentesis and infiltration | 
| Difficulty closing and mouth opening | 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) | Daily 1 week after TMJ arthrocentesis and infiltration | 
| TMJ pain, muscular pain, ear pain | 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) | Daily 1 week after TMJ arthrocentesis and infiltration | 
| Interrupt meals | 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) | Daily 1 week after TMJ arthrocentesis and infiltration | 
| Sleep been interrupted | 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) | Daily 1 week after TMJ arthrocentesis and infiltration | 
| Difficult doing usual jobs | 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) | Daily 1 week after TMJ arthrocentesis and infiltration | 
| Unable to work full capacity | 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) | Daily 1 week after TMJ arthrocentesis and infiltration | 
| Difficult to relax | 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) | Daily 1 week after TMJ arthrocentesis and infiltration | 
| Need of medication after intervention | Indication of the number of SOS analgesic pills taken each day | Daily 1 week after TMJ arthrocentesis and infiltration | 
| TMJ pain assessed by the physiotherapist | 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) | 1 week after injection and TMJ arthrocentesis in a physiotherapy consultation | 
| TMJ pain during lateral deviation assessed by the physiotherapist | 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) | 1 week after injection and TMJ arthrocentesis in a physiotherapy consultation | 
| TMJ pain during protrusion assessed by the physiotherapist | 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) | 1 week after injection and TMJ arthrocentesis in a physiotherapy consultation | 
| Myalgia degree assessed by the physiotherapist | Myalgia degree in right and left masseter and temporalis muscles evaluated by the physiotherapist in a 0-3 scale | 1 week after injection and TMJ arthrocentesis in a physiotherapy consultation | 
| Physiotherapist's perception of comfort during the consultation | For the therapist: in a 0 to 10 scale evaluate your perception of patients comfort during the physical therapy question | 1 week after injection and TMJ arthrocentesis in a physiotherapy consultation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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temporomandibular disorders, temporomandibular joint arthrocentesis, ropivacaine, randomized clinical trial