drugset / Trial / NCT04110587
Hyaluronic Acid Evaluation as Adjuvant to Temporomandibular Joint Arthroscopy
Phase 4
Completed
54 enrolled
Universidad Complutense de Madrid
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa · collabZambon SpA · collab
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2013-12-10
- Primary completion
- 2019-07-09
- Completion
- 2019-07-09
Publications
- Background Montero-Martin J, Bravo-Perez M, Albaladejo-Martinez A, Hernandez-Martin LA, Rosel-Gallardo EM. Validation the Oral Health Impact Profile (OHIP-14sp) for adults in Spain. Med Oral Patol Oral Cir Bucal. 2009 Jan 1;14(1):E44-50.
- Background Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994 Mar;11(1):3-11.
- Background Shi Z, Guo C, Awad M. Hyaluronate for temporomandibular joint disorders. Cochrane Database Syst Rev. 2003;(1):CD002970. doi: 10.1002/14651858.CD002970.
- Background Wilkes CH. Internal derangements of the temporomandibular joint. Pathological variations. Arch Otolaryngol Head Neck Surg. 1989 Apr;115(4):469-77. doi: 10.1001/archotol.1989.01860280067019.
- Castano-Joaqui OG, Cano-Sanchez J, Campo-Trapero J, Munoz-Guerra MF. TMJ arthroscopy with hyaluronic acid: A 12-month randomized clinical trial. Oral Dis. 2021 Mar;27(2):301-311. doi: 10.1111/odi.13524. Epub 2020 Jul 25.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Hyaluronic Acid | Other / unclassified | 1 ml | Other |
| Comparator | Amoxicillin | Other / unclassified | 500 mg | Intravenous |
| Comparator | Dexamethasone | Small molecule | 4 mg | Intravenous |
| Comparator | Diclofenac | Other / unclassified | 100 mg | Oral |
| Comparator | clavulanic acid | Small molecule | 125 mg | Intravenous |
| Comparator | dipyrone | Unknown | 575 mg | Oral |