Hyaluronic Acid Evaluation as Adjuvant to Temporomandibular Joint Arthroscopy

Study Overview
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Brief Summary
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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.

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

Conditions
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Temporomandibular Joint Disc Displacement, Temporomandibular Joint Disorders

Intervention / Treatment
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* Biological: Hyaluronic Acid
* Procedure: Temporomandibular Joint Arthroscopy
* Drug: Antibiotic therapy
* Drug: corticosteroid
* Drug: Antiinflammatories
* Drug: Analgesics
* Other: Exercise program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: arthroscopy<br>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<br>* Lysis and Lavage<br>Drug: Antibiotic therapy<br>* Amoxicillin / Clavulanic Acid, 1g I.V. (Intraoperative); as well as Amoxicillin / clavulanic acid, 500/125 mg / 8h / 5 days by mouth (Post-operative).<br>Drug: corticosteroid<br>* Dexamethasone, 4 mg I.V. (Intraoperative)<br>Drug: Antiinflammatories<br>* Diclofenac 100 mg / 12h / 5 days by mouth (Post-operatively).<br>Drug: Analgesics<br>* Metamizol 575 mg / 8h by mouth (Post-operatively)<br>Other: Exercise program<br>* Home exercise program<br>|
| Active Comparator: arthroscopy plus hyaluronic Acid<br>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<br>* 1 mL Hyaluronic Acid Injection (20 mg/mL, 7000 KDa) at the end of arthroscopy .<br>* Other names: Sodium Hyaluronate;Procedure: Temporomandibular Joint Arthroscopy<br>* Lysis and Lavage<br>Drug: Antibiotic therapy<br>* Amoxicillin / Clavulanic Acid, 1g I.V. (Intraoperative); as well as Amoxicillin / clavulanic acid, 500/125 mg / 8h / 5 days by mouth (Post-operative).<br>Drug: corticosteroid<br>* Dexamethasone, 4 mg I.V. (Intraoperative)<br>Drug: Antiinflammatories<br>* Diclofenac 100 mg / 12h / 5 days by mouth (Post-operatively).<br>Drug: Analgesics<br>* Metamizol 575 mg / 8h by mouth (Post-operatively)<br>Other: Exercise program<br>* Home exercise program<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hyaluronic acid, temporomandibular joint arthroscopy, internal derangements, disc displacement, temporomandibular disorders