Hyaluronic Acid Evaluation as Adjuvant to Temporomandibular Joint Arthroscopy
NCT ID: NCT04110587
Last Updated: 2019-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
54 participants
INTERVENTIONAL
2013-12-10
2019-07-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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arthroscopy
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.
Temporomandibular Joint Arthroscopy
Lysis and Lavage
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).
corticosteroid
Dexamethasone, 4 mg I.V. (Intraoperative)
Antiinflammatories
Diclofenac 100 mg / 12h / 5 days by mouth (Post-operatively).
Analgesics
Metamizol 575 mg / 8h by mouth (Post-operatively)
Exercise program
Home exercise program
arthroscopy plus hyaluronic Acid
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.
Hyaluronic Acid
1 mL Hyaluronic Acid Injection (20 mg/mL, 7000 KDa) at the end of arthroscopy .
Temporomandibular Joint Arthroscopy
Lysis and Lavage
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).
corticosteroid
Dexamethasone, 4 mg I.V. (Intraoperative)
Antiinflammatories
Diclofenac 100 mg / 12h / 5 days by mouth (Post-operatively).
Analgesics
Metamizol 575 mg / 8h by mouth (Post-operatively)
Exercise program
Home exercise program
Interventions
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Hyaluronic Acid
1 mL Hyaluronic Acid Injection (20 mg/mL, 7000 KDa) at the end of arthroscopy .
Temporomandibular Joint Arthroscopy
Lysis and Lavage
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).
corticosteroid
Dexamethasone, 4 mg I.V. (Intraoperative)
Antiinflammatories
Diclofenac 100 mg / 12h / 5 days by mouth (Post-operatively).
Analgesics
Metamizol 575 mg / 8h by mouth (Post-operatively)
Exercise program
Home exercise program
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Limitation of maximum oral opening or duplication of joint pain by palpation
* lack of response to conservative therapies
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
OTHER
Zambon SpA
INDUSTRY
Universidad Complutense de Madrid
OTHER
Responsible Party
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Principal Investigators
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Jorge Cano Sánchez
Role: STUDY_DIRECTOR
Universidad Complutense de Madrid
Julian Campo Trapero
Role: STUDY_DIRECTOR
Universidad Complutense de Madrid
Mario Fernando Muñoz Guerra
Role: STUDY_DIRECTOR
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Oscar Gabriel Castaño Joaqui
Role: PRINCIPAL_INVESTIGATOR
Universidad Complutense de Madrid
Locations
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Hospital Universitario de La Princesa
Madrid, , Spain
Countries
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References
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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.
Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994 Mar;11(1):3-11.
Shi Z, Guo C, Awad M. Hyaluronate for temporomandibular joint disorders. Cochrane Database Syst Rev. 2003;(1):CD002970. doi: 10.1002/14651858.CD002970.
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.
Other Identifiers
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DUROLANE2013
Identifier Type: -
Identifier Source: org_study_id
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