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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
54
1 mL Hyaluronic Acid Injection (20 mg/mL, 7000 KDa) at the end of arthroscopy .
Lysis and Lavage
Amoxicillin / Clavulanic Acid, 1g I.V. (Intraoperative); as well as Amoxicillin / clavulanic acid, 500/125 mg / 8h / 5 days by mouth (Post-operative).
Dexamethasone, 4 mg I.V. (Intraoperative)
Diclofenac 100 mg / 12h / 5 days by mouth (Post-operatively).
Metamizol 575 mg / 8h by mouth (Post-operatively)
Home exercise program
Hospital Universitario de La Princesa
Madrid, Spain
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.
Time frame: 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.
Time frame: 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
Time frame: From enrollment to end of study at 12 Months. Baseline, Month 6, Month 12.
Number of Participants with Treatment Related Adverse Events
any adverse response to the intervention
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.
Symptoms Duration Mean (Months)
symptoms duration mean reported by the participants
Time frame: At baseline
Number of Participants with chondromalacia
arthroscopic finding
Time frame: During intervention
Number of Participants with synovitis
arthroscopic finding
Time frame: During intervention
Irrigation Volume Mean (cc)
average irrigation fluid used during intervention
Time frame: During intervention
Number of Participants with Occlusal Stabilization Splint
stabilization splint use reported by the participant
Time frame: 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
Time frame: At baseline and Month 12.
Number of Participants with joint surfaces flattening by magnetic resonance imaging
radiographic finding in jaw condyle or temporal bone
Time frame: At baseline and Month 12
Number of Participants with Subchondral Geode by magnetic resonance imaging
radiographic finding in jaw condyle
Time frame: At baseline and Month 12
Disc Position by magnetic resonance imaging
No Displacement, Disc Displacement with Reduction, Disc Displacement without Reduction
Time frame: At baseline and Month 12
Number of Participants with pain in masseter muscle by digital palpation
pain reported by the participant
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.
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