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

Not Applicable

Active, not recruiting

• Conditions: Temporomandibular Joint Disorders

• Registration Number: NCT06457698
• Lead Sponsor: Instituto Portugues da Face

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-01
• Status Verified: 2024-06
• Primary Completion: 2024-06-01
• Study First Submitted: 2024-06-09
• Study First Submitted QC: 2024-06-09
• Last Update Submitted: 2024-06-09
• Study First Posted: 2024-06-13
• Last Update Posted: 2024-06-13
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
TMJ arthralgia (VAS, 0-10)	TMJ arthralgia will be assessed preoperatively (T0) and postoperatively (T1 - 1 month, T2 - 3 months, T3 - 6 months, T4 - 12 months follow-up).	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.

Secondary Outcome Measures

Name	Time	Method
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).	MMO was measured using a certified ruler between the incisor's teeth.

Trial Locations

Locations (1)

Instituto Português da Face; 🇵🇹 Lisboa, Portugal