Hyaluronic Acid Evaluation as Adjuvant to Temporomandibular Joint Arthroscopy

Hyaluronic Acid Evaluation as Adjuvant to Temporomandibular Joint Arthroscopy in Wilkes Stages

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 Overview

• Status: Completed
• Conditions: Temporomandibular Joint Disorders; Temporomandibular Joint Disc Displacement
• Intervention / Treatment: Procedure: Temporomandibular Joint Arthroscopy; Drug: Antibiotic therapy; Drug: corticosteroid; Drug: Antiinflammatories; Drug: Analgesics; Other: Exercise program; Biological: Hyaluronic Acid

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28006
    • Hospital Universitario de La Princesa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of temporomandibular joint internal derangements in Wilkes stages III and IV by magnetic resonance imaging
• Limitation of maximum oral opening or duplication of joint pain by palpation
• lack of response to conservative therapies

Exclusion Criteria:

• Any degenerative systemic disease of muscular or joint involvement (rheumatoid arthritis, etc.)
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	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
Active Comparator: 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.	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; Biological: Hyaluronic Acid; 1 mL Hyaluronic Acid Injection (20 mg/mL, 7000 KDa) at the end of arthroscopy .; Other Names: Sodium Hyaluronate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change from Baseline in Pain Scores on the Visual Analog Scale at 3,6,9 and 12 Months	Visual Analog Scale 0 to 10. Higher values represent a worse outcome.	From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.
Mean Change from Baseline in Maximal Oral Opening Scores (mm) at 3,6,9 and 12 Months	measured from edge of upper central incisor to edge of lower antagonist incisor. Range scale 0 to 60 (mm). Higher values represent a better outcome.	From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.
Mean Change from Baseline in Oral Health Impact Profile-14 Spanish Version (OHIP-14sp) questionnaire Scores at 6 and 12 Months	OHIP-14sp questionnaire total average score to measure Oral Health-Related Quality of Life. Range scale 0 to 56. Higher values represent a worse outcome. Total average score is calculated by adding the score of each question and dividing by 14	From enrollment to end of study at 12 Months. Baseline, Month 6, Month 12.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Treatment Related Adverse Events	any adverse response to the intervention	From intervention to end of study at 12 Months. During procedure or immediately after intervention, Month 3, Month 6, Month 9, Month 12.
Symptoms Duration Mean (Months)	symptoms duration mean reported by the participants	At baseline
Number of Participants with chondromalacia	arthroscopic finding	During intervention
Number of Participants with synovitis	arthroscopic finding	During intervention
Irrigation Volume Mean (cc)	average irrigation fluid used during intervention	During intervention
Number of Participants with Occlusal Stabilization Splint	stabilization splint use reported by the participant	From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.
Number of Participants with Osteophyte by magnetic resonance imaging	radiographic finding in jaw condyle	At baseline and Month 12.
Number of Participants with joint surfaces flattening by magnetic resonance imaging	radiographic finding in jaw condyle or temporal bone	At baseline and Month 12
Number of Participants with Subchondral Geode by magnetic resonance imaging	radiographic finding in jaw condyle	At baseline and Month 12
Disc Position by magnetic resonance imaging	No Displacement, Disc Displacement with Reduction, Disc Displacement without Reduction	At baseline and Month 12
Number of Participants with pain in masseter muscle by digital palpation	pain reported by the participant	From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.
Number of Participants with pain in Temporal muscle by digital palpation	pain reported by the participant	From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.
Number of Participants with pain in Medial Pterygoid Muscle by digital palpation	pain reported by the participant	From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.
Number of Participants with pain in digastric Muscle by digital palpation	pain reported by the participant	From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.
Number of Participants with pain in Genihyoid Muscle by digital palpation	pain reported by the participant	From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.
Number of Participants with pain in Mylohyoid Muscle by digital palpation	pain reported by the participant	From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid
• Collaborators: Zambon SpA; Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
• Investigators: Study Director: Jorge Cano Sánchez, Complutense University of Madrid; Study Director: Julian Campo Trapero, Complutense University of Madrid; Study Director: Mario Fernando Muñoz Guerra, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa; Principal Investigator: Oscar Gabriel Castaño Joaqui, Complutense University of Madrid

Publications and helpful links

General Publications

• Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994 Mar;11(1):3-11.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2013
• Primary Completion (Actual): July 9, 2019
• Study Completion (Actual): July 9, 2019

Study Registration Dates

• First Submitted: September 23, 2019
• First Submitted That Met QC Criteria: September 28, 2019
• First Posted (Actual): October 1, 2019

Study Record Updates

• Last Update Posted (Actual): October 1, 2019
• Last Update Submitted That Met QC Criteria: September 28, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: hyaluronic acid; temporomandibular disorders; temporomandibular joint arthroscopy; internal derangements; disc displacement
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Physiological Effects of Drugs; Anti-Infective Agents; Peripheral Nervous System Agents; Sensory System Agents; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Anti-Inflammatory Agents; Anti-Bacterial Agents; Hyaluronic Acid; Analgesics
• Other Study ID Numbers: DUROLANE2013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO