Hyaluronic Acid Evaluation as Adjuvant to Temporomandibular Joint Arthroscopy

NCT04110587 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2019-10-01

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

    collaborator OTHER
  • Zambon SpA

    collaborator INDUSTRY
  • Universidad Complutense de Madrid

    lead OTHER

Principal Investigators

  • Jorge Cano Sánchez · Universidad Complutense de Madrid

  • Julian Campo Trapero · Universidad Complutense de Madrid

  • Mario Fernando Muñoz Guerra · Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

  • Oscar Gabriel Castaño Joaqui · Universidad Complutense de Madrid

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-10
Primary Completion
2019-07-09
Completion
2019-07-09

Countries

  • Spain

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04110587 on ClinicalTrials.gov