Temporomandibular Joint Arthrocentesis With Infiltration of PRP + Ropivacaine Versus PRP

NCT05817162 | Unknown Phase 4

• 1 other identifier: ROPIVACAINE_TMJ
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Joint Disorders

Keywords

temporomandibular disorders; temporomandibular joint arthrocentesis; ropivacaine; randomized clinical trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Postoperative pain

  Daily 1 week after TMJ arthrocentesis and infiltration

• General state pre vs post

  Daily 1 week after TMJ arthrocentesis and infiltration

• Functional limitation chewing foods

  Daily 1 week after TMJ arthrocentesis and infiltration

• Difficulty closing and mouth opening

  Daily 1 week after TMJ arthrocentesis and infiltration

• TMJ pain, muscular pain, ear pain

  Daily 1 week after TMJ arthrocentesis and infiltration

Study Arms (2)

Placebo Group: PRP

PLACEBO COMPARATOR

Temporomandibular joint arthrocentesis, Ringer lactate for washing, and 1ml PRP infiltration in each temporomandibular joint

Procedure: temporomandibular joint arthrocentesis; Drug: PRP injection; Drug: Ringer's Lactate solution

PRP + Ropivacaine

ACTIVE COMPARATOR

Temporomandibular joint arthrocentesis, Ringer lactate for washing, and 1ml PRP + ropivacaine infiltration in each temporomandibular joint

Drug: Ropivacaine injection; Procedure: temporomandibular joint arthrocentesis; Drug: PRP injection; Drug: Ringer's Lactate solution

Interventions

Ropivacaine injection DRUG

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.

PRP + Ropivacaine

temporomandibular joint arthrocentesis PROCEDURE

Temporomandibular arthrocentesis is a minimally invasive surgical procedure, which aims to eliminate the inflammatory mediators from the inside of the TMJ.

PRP + Ropivacaine; Placebo Group: PRP

PRP injection DRUG

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

PRP + Ropivacaine; Placebo Group: PRP

Ringer's Lactate solution DRUG

Ringers lactate solution is used during arthrocentesis to wash out the joint inflammatory cells and to release the stuck disc phenomenon.

PRP + Ropivacaine; Placebo Group: PRP

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Portugues da Face: lead

Study Sites (1)

Instituto Português da Face

Lisbon, 1050-227, Portugal

Location

Related Publications (3)

• Derwich M, Mitus-Kenig M, Pawlowska E. Mechanisms of Action and Efficacy of Hyaluronic Acid, Corticosteroids and Platelet-Rich Plasma in the Treatment of Temporomandibular Joint Osteoarthritis-A Systematic Review. Int J Mol Sci. 2021 Jul 9;22(14):7405. doi: 10.3390/ijms22147405.

  PMID: 34299024 BACKGROUND

• Keyser C, Bhashyam A, Abdurrob A, Smith JT, Bluman E, Chiodo C. Excess Opioid Disposal Following Orthopaedic Surgery: A Randomized Clinical Trial. Foot Ankle Spec. 2022 Dec;15(6):545-550. doi: 10.1177/1938640020980921. Epub 2020 Dec 27.

  PMID: 33356547 BACKGROUND

• Rao TN, Goswami D, Roychoudhury A, Bhutia O, Baidya DK, Trikha A. Efficacy of Local Anesthetic Wound Infiltration in Temporomandibular Joint Ankylosis Surgery for Control of Postoperative Pain: A Prospective, Randomized Controlled, and Double-Blinded Trial. J Oral Maxillofac Surg. 2021 Mar;79(3):559.e1-559.e11. doi: 10.1016/j.joms.2020.10.034. Epub 2020 Oct 29.

  PMID: 33232658 BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Ropivacaine; Arthrocentesis; Ringer's Lactate

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The distribution of intervention is performed by attributing a code for each patient. Each code will have been previously distributed randomly between PRP + Ropicavaine and PRP only. The codes are kept closed singularly in an envelope. Before treatment, the nurse will ask the patient to choose an envelope. At this moment, the envelope is placed on a table, and the patient writes his name. Alone, the nurse opens the envelope and sees the code and the indication of PRP or PRP + Ropivacaine. Then, she will prepare, in her room, isolated from the whole team, one 3cc syringe with PRP or PRP + 1cc ropivacaine (7.5mg/ml), depending on the code. Once the code is attributed to the patient, she will deliver a tray with the prepared syringe for treatment. After finishing the arthrocentesis, the doctor injects the chosen treatment. Daily for one week, the patient answers a questionnaire, and at the end of the postoperative week, each patient will be blinded evaluated with a clinical examination.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: April 18, 2023
• Study Start: April 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: July 1, 2024
• Last Updated: April 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)