Temporomandibular Joint Arthrocentesis With Infiltration of PRP + Ropivacaine Versus PRP
NCT05817162 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2023-04-20
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
Interventions
- 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
- DRUG
-
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.
Sponsors & Collaborators
-
Instituto Portugues da Face
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-01
- Primary Completion
- 2024-04-01
- Completion
- 2024-07-01
Countries
- Portugal
Study Locations
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