CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 54 enrolled
Drug / intervention
Hyaluronic Acid +6 morebiological
Likely dose
Hyaluronic Acid 1 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04110587
NCT04110587Phase 4Completed
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Hyaluronic Acid Evaluation as Adjuvant to Temporomandibular Joint Arthroscopy in Wilkes Stages

Universidad Complutense de Madrid·interventional·Posted Oct 1, 2019·Updated Oct 1, 2019

In Brief

A Phase 4 clinical trial evaluating Hyaluronic Acid, Temporomandibular Joint Arthroscopy, and 5 other interventions for Temporomandibular Joint Disc Displacement and Temporomandibular Joint Disorders. Completed, enrolled 54 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTemporomandibular Joint Disc Displacement, Temporomandibular Joint Disorders
CountriesSpain
CollaboratorsFundación de Investigación Biomédica - Hospital Universitario de La Princesa, Zambon SpA

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 1, 2019
Enrollment StartDec 10, 2013
Primary CompletionJul 9, 2019
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 6.8 years ago

Interventions

Hyaluronic Acidbiological

1 mL Hyaluronic Acid Injection (20 mg/mL, 7000 KDa) at the end of arthroscopy .

Temporomandibular Joint Arthroscopyprocedure

Lysis and Lavage

Antibiotic therapydrug

Amoxicillin / Clavulanic Acid, 1g I.V. (Intraoperative); as well as Amoxicillin / clavulanic acid, 500/125 mg / 8h / 5 days by mouth (Post-operative).

corticosteroiddrug

Dexamethasone, 4 mg I.V. (Intraoperative)

Antiinflammatoriesdrug

Diclofenac 100 mg / 12h / 5 days by mouth (Post-operatively).

Analgesicsdrug

Metamizol 575 mg / 8h by mouth (Post-operatively)

Exercise programother

Home exercise program