Hyaluronic Acid Evaluation as Adjuvant to Temporomandibular Joint Arthroscopy

NCT04110587 | Completed Phase 4

• 1 other identifier: DUROLANE2013
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

hyaluronic acid; temporomandibular joint arthroscopy; internal derangements; disc displacement; temporomandibular disorders

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (16)

• Number of Participants with Treatment Related Adverse Events

  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)

  At baseline

• Number of Participants with chondromalacia

  During intervention

• Number of Participants with synovitis

  During intervention

• Irrigation Volume Mean (cc)

  During intervention

Study Arms (2)

arthroscopy

PLACEBO COMPARATOR

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; Drug: Antibiotic therapy; Drug: corticosteroid; Drug: Antiinflammatories; Drug: Analgesics; Other: Exercise program

arthroscopy plus hyaluronic Acid

ACTIVE COMPARATOR

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.

Biological: Hyaluronic Acid; Procedure: Temporomandibular Joint Arthroscopy; Drug: Antibiotic therapy; Drug: corticosteroid; Drug: Antiinflammatories; Drug: Analgesics; Other: Exercise program

Interventions

Hyaluronic Acid BIOLOGICAL

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

Also known as: Sodium Hyaluronate

arthroscopy plus hyaluronic Acid

Temporomandibular Joint Arthroscopy PROCEDURE

Lysis and Lavage

arthroscopy; arthroscopy plus hyaluronic Acid

Antibiotic therapy DRUG

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

arthroscopy; arthroscopy plus hyaluronic Acid

corticosteroid DRUG

Dexamethasone, 4 mg I.V. (Intraoperative)

arthroscopy; arthroscopy plus hyaluronic Acid

Antiinflammatories DRUG

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

arthroscopy; arthroscopy plus hyaluronic Acid

Analgesics DRUG

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

arthroscopy; arthroscopy plus hyaluronic Acid

Exercise program OTHER

Home exercise program

arthroscopy; arthroscopy plus hyaluronic Acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• Fundación de Investigación Biomédica - Hospital Universitario de La Princesa: collaborator
• Zambon SpA: collaborator

Study Sites (1)

Hospital Universitario de La Princesa

Madrid, 28006, Spain

Location

Related Publications (5)

• 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.

  PMID: 19114956 BACKGROUND

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

  PMID: 8193981 BACKGROUND

• Shi Z, Guo C, Awad M. Hyaluronate for temporomandibular joint disorders. Cochrane Database Syst Rev. 2003;(1):CD002970. doi: 10.1002/14651858.CD002970.

  PMID: 12535445 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.

  PMID: 2923691 BACKGROUND

• 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.

  PMID: 32609918 DERIVED

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Hyaluronic Acid; Anti-Infective Agents; Adrenal Cortex Hormones; Anti-Inflammatory Agents; Analgesics; Resistance Training

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Central Nervous System Agents; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jorge Cano Sánchez

  Universidad Complutense de Madrid

  STUDY DIRECTOR

• Julian Campo Trapero

  Universidad Complutense de Madrid

  STUDY DIRECTOR

• Mario Fernando Muñoz Guerra

  Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

  STUDY DIRECTOR

• Oscar Gabriel Castaño Joaqui

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Treatment allocation was concealed from participants and examiner (using sealed and numbered opaque envelopes by the research coordinator), and the data analyst (by encoded data).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: October 1, 2019
• Study Start: December 10, 2013
• Primary Completion: July 9, 2019
• Study Completion: July 9, 2019
• Last Updated: October 1, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)