Temporomandibular Joint Arthrocentesis With Infiltration of PRP + Ropivacaine Versus PRP

Temporomandibular Joint Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05817162
• Other study ID #: ROPIVACAINE_TMJ
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: April 1, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: March 2023
• Source: Instituto Portugues da Face
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: July 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Joint Diseases
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Drug:
• Ropivacaine injection
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.

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

Drug:
• PRP injection
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
• Ringer's Lactate solution
Ringers lactate solution is used during arthrocentesis to wash out the joint inflammatory cells and to release the stuck disc phenomenon.

Locations

Country	Name	City	State
Portugal	Instituto Português da Face	Lisboa

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Portugues da Face

Country where clinical trial is conducted

Portugal, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Need of medication after intervention	Indication of the number of SOS analgesic pills taken each day	Daily 1 week after TMJ arthrocentesis and infiltration
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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