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

NCT06457698 | Active Not Recruiting

• 1 other identifier: SUPERPRP
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Temporomandibular Joint Disorders

Keywords

Hyaluronic acid; platelet-rich plasma; arthrocentesis; viscosuplementation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• maximum mouth opening (MMO)

  MMO will be assessed preoperatively (T0) and postoperatively (T1 - 1 month, T2 - 3 months, T3 - 6 months, T4 - 12 months follow-up).

Study Arms (2)

HA injection

PLACEBO COMPARATOR

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

HA + PRP injection

ACTIVE COMPARATOR

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

Interventions

Double-puncture TMJ arthrocentesis under local anaesthesia PROCEDURE

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.

HA + PRP injection; HA injection

Eligibility Criteria

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

You may qualify if:

• (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.

Sponsors & Collaborators

• Instituto Portugues da Face: lead

Study Sites (1)

Instituto Português da Face

Lisbon, 1050-227, Portugal

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Subjects were randomly assigned into two groups: HA injection or HA injection + PRP. Codes were prepared and distributed in the two groups for this allocation. The treatment assignment was made by an independent person who was not involved in performing any other procedures in the study, such as the preoperative injection or the TMJ arthrocentesis. An envelope containing a code was selected and assigned to the patient. Subjects were blinded until the end of the study. The surgeon was unblinded because they could distinguish the color of the two viscosupplements.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2024
• First Posted: June 13, 2024
• Study Start: June 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)