Hyaluronic Acid Evaluation as Adjuvant to Temporomandibular Joint Arthroscopy

Universidad Complutense de Madrid

Status and phase: Completed; Phase 4

Conditions: Temporomandibular Joint Disorders; Temporomandibular Joint Disc Displacement

Treatments: Drug: Analgesics; Drug: Antibiotic therapy; Procedure: Temporomandibular Joint Arthroscopy; Drug: Antiinflammatories; Biological: Hyaluronic Acid; Drug: corticosteroid; Other: Exercise program

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04110587

DUROLANE2013

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of temporomandibular joint internal derangements in Wilkes stages III and IV by magnetic resonance imaging
• Limitation of maximum oral opening or duplication of joint pain by palpation
• lack of response to conservative therapies

Exclusion criteria

• Any degenerative systemic disease of muscular or joint involvement (rheumatoid arthritis, etc.)
• Previous temporomandibular joint surgical treatment: arthrocentesis, arthroscopy or open surgery
• Infection in Temporomandibular Joint or in puncture site
• Hyaluronic acid or corticosteroids injection in Temporomandibular Joint in previous 6 months
• Pregnant or breastfeeding women
• Participants who refuse to complete the treatment or unavailable to complete the follow-up

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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54 participants in 2 patient groups, including a placebo group

arthroscopy

Placebo Comparator group

Description:

Temporomandibular joint arthroscopy is performed under general anesthesia by the same expert temporomandibular joint arthroscopy surgeon. Lysis and Lavage is performed in the upper joint space in all cases. Ringer's lactate is use as irrigation fluid. All participants receive Amoxicillin / Clavulanic Acid, 1g I.V. and Dexamethasone, 4 mg I.V. (Intraoperative); as well as Amoxicillin / clavulanic acid, 500/125 mg / 8h / 5 days by mouth; Diclofenac 100 mg / 12h / 5 days by mouth; and Metamizol 575 mg / 8h by mouth (Post-operatively). Soft diet and a home exercise program are implemented in all patients after 24 hours post-operative.

Treatment:

Drug: Analgesics

Procedure: Temporomandibular Joint Arthroscopy

Drug: Antiinflammatories

Drug: corticosteroid

Drug: Antibiotic therapy

Other: Exercise program

arthroscopy plus hyaluronic Acid

Active Comparator group

Description:

Temporomandibular joint arthroscopy is performed under general anesthesia by the same expert temporomandibular joint arthroscopy surgeon. Lysis and Lavage is performed in the upper joint space in all cases. Ringer's lactate is use as irrigation fluid. All participants receive Amoxicillin / Clavulanic Acid, 1g I.V. and Dexamethasone, 4 mg I.V. (Intraoperative); as well as Amoxicillin / clavulanic acid, 500/125 mg / 8h / 5 days by mouth; Diclofenac 100 mg / 12h / 5 days by mouth; and Metamizol 575 mg / 8h by mouth (Post-operatively). Soft diet and a home exercise program are implemented in all patients after 24 hours post-operative. An hyaluronic acid injection of 1 mL (Durolane®, 20 mg / mL, Zambon, Barcelona, Spain) at the end of arthroscopy that was only performed in this arm.

Treatment:

Drug: Analgesics

Procedure: Temporomandibular Joint Arthroscopy

Drug: Antiinflammatories

Drug: corticosteroid

Drug: Antibiotic therapy

Biological: Hyaluronic Acid

Other: Exercise program