Hyaluronic Acid Evaluation as Adjuvant to Temporomandibular Joint Arthroscopy
NCT04110587 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 54
Last updated 2019-10-01
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
-
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
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