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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Temporomandibular Joint Disorders
• Intervention / Treatment: Procedure: Double-puncture TMJ arthrocentesis under local anaesthesia

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Lisboa, Portugal, 1050-227
    • Instituto Português da Face

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: HA injection; After TMJ double-puncture arthrocenthesis under local anesthesia, hyaluronic acid (Suplasyn®, 20 mg/ml) will be injected in the joint with the first portal.	Procedure: Double-puncture TMJ arthrocentesis under local anaesthesia; The first puncture involved carefully palpating the lateral rim of the glenoid fossa. A 5-cc syringe was prepared with a mixture of 3 cc of Ringer lactate and 1.8 cc of lidocaine with epinephrine. A 21-G needle connected to the syringe was gently inserted into the TMJ skin area. Once the needle tip made contact with the posterior slope of the eminence of the upper joint compartment, it was oriented vertically to access the upper compartment, allowing the surgeon to perform a validation step. For the second puncture, the joint was maintained at maximum distention with continuous inflow through the first portal, while the surgeon felt insufflation/distention in the anterior joint area. The second portal was established using a 21-G needle with successful fluid outflow. After completing an effective circuit, joint washing was carried out using intra-articular hydraulic pressure with at least 150 ml of Ringer lactate solution.
Active Comparator: HA + PRP injection; 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.	Procedure: Double-puncture TMJ arthrocentesis under local anaesthesia; The first puncture involved carefully palpating the lateral rim of the glenoid fossa. A 5-cc syringe was prepared with a mixture of 3 cc of Ringer lactate and 1.8 cc of lidocaine with epinephrine. A 21-G needle connected to the syringe was gently inserted into the TMJ skin area. Once the needle tip made contact with the posterior slope of the eminence of the upper joint compartment, it was oriented vertically to access the upper compartment, allowing the surgeon to perform a validation step. For the second puncture, the joint was maintained at maximum distention with continuous inflow through the first portal, while the surgeon felt insufflation/distention in the anterior joint area. The second portal was established using a 21-G needle with successful fluid outflow. After completing an effective circuit, joint washing was carried out using intra-articular hydraulic pressure with at least 150 ml of Ringer lactate solution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TMJ arthralgia (VAS, 0-10)	The level of TMJ arthralgia was registered through pain during palpation of the lateral pole or around the lateral pole or pain on maximum unassisted or assisted opening, right or left lateral movements, or protrusive movements, following the DC/TMD guidelines.12, 13 Patient scored for each side using a 10-point VAS, from 0-no pain and 10-severe pain.	TMJ arthralgia will be assessed preoperatively (T0) and postoperatively (T1 - 1 month, T2 - 3 months, T3 - 6 months, T4 - 12 months follow-up).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
maximum mouth opening (MMO)	MMO was measured using a certified ruler between the incisor's teeth.	MMO will be assessed preoperatively (T0) and postoperatively (T1 - 1 month, T2 - 3 months, T3 - 6 months, T4 - 12 months follow-up).

Collaborators and Investigators

• Sponsor: Instituto Portugues da Face

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: June 9, 2024
• First Submitted That Met QC Criteria: June 9, 2024
• First Posted (Actual): June 13, 2024

Study Record Updates

• Last Update Posted (Actual): June 13, 2024
• Last Update Submitted That Met QC Criteria: June 9, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Hyaluronic acid; platelet-rich plasma; arthrocentesis; viscosuplementation
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: SUPERPRP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No