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Completed

NCT Number: NCT04110587

Hyaluronic Acid Evaluation as Adjuvant to Temporomandibular Joint Arthroscopy

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.

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Key information

Conditions

Temporomandibular Joint Disc Displacement Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitario de La Princesa

Madrid, 28006, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyaluronic Acid

Biological

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

Other names: Sodium Hyaluronate

Temporomandibular Joint Arthroscopy

Procedure

Lysis and Lavage

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).

Corticosteroid

Drug

Dexamethasone, 4 mg I.V. (Intraoperative)

Antiinflammatories

Drug

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

Analgesics

Drug

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

exercise program

Other

Home exercise program

Primary outcomes

  1. Mean Change from Baseline in Pain Scores on the Visual Analog Scale at 3,6,9 and 12 Months

    Time frame: From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.

    Visual Analog Scale 0 to 10. Higher values represent a worse outcome.

  2. Mean Change from Baseline in Maximal Oral Opening Scores (mm) at 3,6,9 and 12 Months

    Time frame: From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.

    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.

  3. Mean Change from Baseline in Oral Health Impact Profile-14 Spanish Version (OHIP-14sp) questionnaire Scores at 6 and 12 Months

    Time frame: From enrollment to end of study at 12 Months. Baseline, Month 6, Month 12.

    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

Secondary outcomes

  1. Number of Participants with Treatment Related Adverse Events

    Time frame: From intervention to end of study at 12 Months. During procedure or immediately after intervention, Month 3, Month 6, Month 9, Month 12.

    any adverse response to the intervention

  2. Symptoms Duration Mean (Months)

    Time frame: At baseline

    symptoms duration mean reported by the participants

  3. Number of Participants with chondromalacia

    Time frame: During intervention

    arthroscopic finding

  4. Number of Participants with synovitis

    Time frame: During intervention

    arthroscopic finding

  5. Irrigation Volume Mean (cc)

    Time frame: During intervention

    average irrigation fluid used during intervention

  6. Number of Participants with Occlusal Stabilization Splint

    Time frame: From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.

    stabilization splint use reported by the participant

  7. Number of Participants with Osteophyte by magnetic resonance imaging

    Time frame: At baseline and Month 12.

    radiographic finding in jaw condyle

  8. Number of Participants with joint surfaces flattening by magnetic resonance imaging

    Time frame: At baseline and Month 12

    radiographic finding in jaw condyle or temporal bone

  9. Number of Participants with Subchondral Geode by magnetic resonance imaging

    Time frame: At baseline and Month 12

    radiographic finding in jaw condyle

  10. Disc Position by magnetic resonance imaging

    Time frame: At baseline and Month 12

    No Displacement, Disc Displacement with Reduction, Disc Displacement without Reduction

  11. Number of Participants with pain in masseter muscle by digital palpation

    Time frame: From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.

    pain reported by the participant

  12. Number of Participants with pain in Temporal muscle by digital palpation

    Time frame: From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.

    pain reported by the participant

  13. Number of Participants with pain in Medial Pterygoid Muscle by digital palpation

    Time frame: From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.

    pain reported by the participant

  14. Number of Participants with pain in digastric Muscle by digital palpation

    Time frame: From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.

    pain reported by the participant

  15. Number of Participants with pain in Genihyoid Muscle by digital palpation

    Time frame: From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.

    pain reported by the participant

  16. Number of Participants with pain in Mylohyoid Muscle by digital palpation

    Time frame: From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.

    pain reported by the participant

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Collaborators

  • Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
  • Zambon SpA

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Oct 1, 2019
Registry last updated
Oct 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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