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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06457698
Enrollment
50
Registered
2024-06-13
Start date
2022-06-01
Completion date
2024-12-01
Last updated
2024-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular Joint Disorders

Keywords

Hyaluronic acid, platelet-rich plasma, arthrocentesis, viscosuplementation

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.

Interventions

PROCEDUREDouble-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.

Sponsors

Instituto Portugues da Face
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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.

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026