Temporomandibular Joint Disc Displacement, Temporomandibular Joint Disorders
Conditions
Keywords
hyaluronic acid, temporomandibular joint arthroscopy, internal derangements, disc displacement, temporomandibular disorders
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.
Interventions
BIOLOGICALHyaluronic Acid
1 mL Hyaluronic Acid Injection (20 mg/mL, 7000 KDa) at the end of arthroscopy .
PROCEDURETemporomandibular Joint Arthroscopy
Lysis and Lavage
DRUGAntibiotic therapy
Amoxicillin / Clavulanic Acid, 1g I.V. (Intraoperative); as well as Amoxicillin / clavulanic acid, 500/125 mg / 8h / 5 days by mouth (Post-operative).
DRUGcorticosteroid
Dexamethasone, 4 mg I.V. (Intraoperative)
DRUGAntiinflammatories
Diclofenac 100 mg / 12h / 5 days by mouth (Post-operatively).
DRUGAnalgesics
Metamizol 575 mg / 8h by mouth (Post-operatively)
OTHERExercise program
Home exercise program
Sponsors
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Zambon SpA
Universidad Complutense de Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with synovitis | During intervention | arthroscopic finding |
| Irrigation Volume Mean (cc) | During intervention | average irrigation fluid used during intervention |
| 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 |
| Number of Participants with Osteophyte by magnetic resonance imaging | At baseline and Month 12. | radiographic finding in jaw condyle |
| 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 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 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 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 |
| 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 |
| 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 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 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 |
| Disc Position by magnetic resonance imaging | At baseline and Month 12 | No Displacement, Disc Displacement with Reduction, Disc Displacement without Reduction |
| Symptoms Duration Mean (Months) | At baseline | symptoms duration mean reported by the participants |
| Number of Participants with chondromalacia | During intervention | arthroscopic finding |
Countries
Spain
Outcome results
None listed