NCT04110587

Hyaluronic Acid Evaluation as Adjuvant to Temporomandibular Joint Arthroscopy

Hyaluronic Acid Evaluation as Adjuvant to Temporomandibular Joint Arthroscopy in Wilkes Stages

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Universidad Complutense de Madrid · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the addition of hyaluronic acid to temporomandibular joint arthroscopy in the treatment of internal derangements in adults. A participants group will receive temporomandibular joint arthroscopy plus hyaluronic acid, while the other group will receive temporomandibular joint arthroscopy. Hypothesis: hyaluronic acid as an adjunct in temporomandibular joint arthroscopic surgery provides additional benefits in clinical and radiological outcomes in temporomandibular joint internal derangements.

Conditions

• Temporomandibular Joint Disc Displacement
• Temporomandibular Joint Disorders

Interventions

Type	Name	Description
BIOLOGICAL	Hyaluronic Acid	1 mL Hyaluronic Acid Injection (20 mg/mL, 7000 KDa) at the end of arthroscopy .
PROCEDURE	Temporomandibular Joint Arthroscopy	Lysis and Lavage
DRUG	Antibiotic therapy	Amoxicillin / Clavulanic Acid, 1g I.V. (Intraoperative); as well as Amoxicillin / clavulanic acid, 500/125 mg / 8h / 5 days by mouth (Post-operative).
DRUG	corticosteroid	Dexamethasone, 4 mg I.V. (Intraoperative)
DRUG	Antiinflammatories	Diclofenac 100 mg / 12h / 5 days by mouth (Post-operatively).
DRUG	Analgesics	Metamizol 575 mg / 8h by mouth (Post-operatively)
OTHER	Exercise program	Home exercise program

Timeline

• Start date: 2013-12-10
• Primary completion: 2019-07-09
• Completion: 2019-07-09
• First posted: 2019-10-01
• Last updated: 2019-10-01

Locations

1 site across 1 country: Spain