Temporomandibular Bioviscosuplementation (Platelet-Rich Plasma Combined With Hyaluronic Acid) After Double-Puncture Arthrocentesis: a Randomized Controlled Trial

Instituto Portugues da Face

Status: Active, not recruiting

Conditions: Temporomandibular Joint Disorders

Treatments: Procedure: Double-puncture TMJ arthrocentesis under local anaesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT06457698

SUPERPRP

Details and patient eligibility

About

Intra-articular injections of hyaluronic acid (HA) or platelet-rich plasma (PRP) have been used with temporomandibular joint (TMJ) arthrocentesis to improve lubricative properties and influence regenerative processes. A randomized, controlled clinical trial investigated the benefits of complementary bioviscosuplementation (HA+PRP) in patients submitted to double-portal TMJ arthrocentesis.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• (1) age >18 years; (2) history of conservative treatment for TMD without significant improvement for at least three months; (3) clinical diagnosis of unilateral or bilateral intra-articular disorder; (3) clinical criteria for unilateral or bilateral TMJ arthrocentesis; (4) magnetic resonance imaging (MRI) and computed tomography (CT) documenting arthrogenous derangement.

Exclusion criteria

• The exclusion criteria included: 1) any history of previous TMJ surgical intervention or any facial trauma within the last 4 weeks before the study; 2) concomitant other contralateral TMJ surgery; 3) severe medical problems or mental illness and pregnancy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

HA injection

Placebo Comparator group

Description:

After TMJ double-puncture arthrocenthesis under local anesthesia, hyaluronic acid (Suplasyn®, 20 mg/ml) will be injected in the joint with the first portal.

Treatment:

Procedure: Double-puncture TMJ arthrocentesis under local anaesthesia

HA + PRP injection

Active Comparator group

Description:

32ml of venous blood per joint will be collected and added to four 8ml-collection tubes containing sodium citrate. Then, blood will be centrifugated at 800rpm for 8 minutes at room temperature. 3 layers are perceptible: (1)layer with platelet-rich plasma and growth factors; (2)layer with white blood cells; (3)layer corresponding to red blood cells. Then, the total plasma volume will be calculated, and the plasma corresponding to the first fraction (low platelet fraction) aspirated. The second fraction of the first layer corresponding to PRP, above the white blood cell layer, will be removed and transferred to new tubes. 10 minutes before the mixing with HA, a calcium chloride-rich activator (Endoret ®, BTI Biotechnology Institute, Vitoria-Gasteiz, Álava, Spain) will be added to the PRP. The mixture of PRP with HA was then carried out at a ratio of 1cc of low molecular weight HA (Suplasyn®, 20 mg/ml) +1cc of PRP and introduced in the joint with the first portal.

Treatment:

Procedure: Double-puncture TMJ arthrocentesis under local anaesthesia