Hyaluronic Acid Evaluation as Adjuvant to Temporomandibular Joint Arthroscopy
Phase 4
Completed
- Conditions
- Temporomandibular Joint DisordersTemporomandibular Joint Disc Displacement
- Interventions
- Procedure: Temporomandibular Joint ArthroscopyBiological: Hyaluronic AcidDrug: Antibiotic therapyDrug: corticosteroidDrug: AntiinflammatoriesOther: Exercise program
- Registration Number
- NCT04110587
- Lead Sponsor
- Universidad Complutense de Madrid
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description arthroscopy Temporomandibular Joint 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. arthroscopy plus hyaluronic Acid corticosteroid 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. arthroscopy Antibiotic therapy 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. arthroscopy corticosteroid 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. arthroscopy Antiinflammatories 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. arthroscopy plus hyaluronic Acid Temporomandibular Joint 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. 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. arthroscopy Exercise program 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. arthroscopy plus hyaluronic Acid 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. arthroscopy plus hyaluronic Acid Antiinflammatories 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. arthroscopy plus hyaluronic Acid Exercise program 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. arthroscopy plus hyaluronic Acid Antibiotic therapy 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. arthroscopy Analgesics 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. arthroscopy plus hyaluronic Acid Analgesics 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.
- Primary Outcome Measures
Name Time Method Mean Change from Baseline in Pain Scores on the Visual Analog Scale at 3,6,9 and 12 Months 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.
Mean Change from Baseline in Maximal Oral Opening Scores (mm) at 3,6,9 and 12 Months 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.
Mean Change from Baseline in Oral Health Impact Profile-14 Spanish Version (OHIP-14sp) questionnaire Scores at 6 and 12 Months 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 Outcome Measures
Name Time Method Number of Participants with Osteophyte by magnetic resonance imaging At baseline and Month 12. radiographic finding in jaw condyle
Number of Participants with pain in Temporal muscle by digital palpation From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12. pain reported by the participant
Symptoms Duration Mean (Months) At baseline symptoms duration mean reported by the participants
Number of Participants with chondromalacia During intervention arthroscopic finding
Irrigation Volume Mean (cc) During intervention average irrigation fluid used during intervention
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. any adverse response to the intervention
Number of Participants with synovitis During intervention arthroscopic finding
Number of Participants with Occlusal Stabilization Splint 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
Disc Position by magnetic resonance imaging At baseline and Month 12 No Displacement, Disc Displacement with Reduction, Disc Displacement without Reduction
Number of Participants with pain in Genihyoid Muscle by digital palpation From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12. pain reported by the participant
Number of Participants with joint surfaces flattening by magnetic resonance imaging At baseline and Month 12 radiographic finding in jaw condyle or temporal bone
Number of Participants with Subchondral Geode by magnetic resonance imaging At baseline and Month 12 radiographic finding in jaw condyle
Number of Participants with pain in masseter muscle by digital palpation From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12. pain reported by the participant
Number of Participants with pain in Mylohyoid Muscle by digital palpation From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12. pain reported by the participant
Number of Participants with pain in digastric Muscle by digital palpation From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12. pain reported by the participant
Number of Participants with pain in Medial Pterygoid Muscle by digital palpation From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12. pain reported by the participant
Trial Locations
- Locations (1)
Hospital Universitario de La Princesa
🇪🇸Madrid, Spain