Clinical trial NCT04110587: Hyaluronic Acid Evaluation as Adjuvant to Temporomandibular Joint Arthroscopy
Official title: Hyaluronic Acid Evaluation as Adjuvant to Temporomandibular Joint Arthroscopy in Wilkes Stages
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Temporomandibular Joint Disc Displacement
Temporomandibular Joint Disorders
Keywords: hyaluronic acid
temporomandibular joint arthroscopy
internal derangements
disc displacement
temporomandibular disorders
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
Collaborators: name: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
name: Zambon SpA
First posted: 2019-10-01
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean Change from Baseline in Pain Scores on the Visual Analog Scale at 3,6,9 and 12 Months
timeFrame: From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.
measure: Mean Change from Baseline in Maximal Oral Opening Scores (mm) at 3,6,9 and 12 Months
timeFrame: From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.
measure: Mean Change from Baseline in Oral Health Impact Profile-14 Spanish Version (OHIP-14sp) questionnaire Scores at 6 and 12 Months
timeFrame: From enrollment to end of study at 12 Months. Baseline, Month 6, Month 12.
Secondary outcomes:
measure: Number of Participants with Treatment Related Adverse Events
timeFrame: From intervention to end of study at 12 Months. During procedure or immediately after intervention, Month 3, Month 6, Month 9, Month 12.
measure: Symptoms Duration Mean (Months)
timeFrame: At baseline
measure: Number of Participants with chondromalacia
timeFrame: During intervention
measure: Number of Participants with synovitis
timeFrame: During intervention
measure: Irrigation Volume Mean (cc)
timeFrame: During intervention
measure: Number of Participants with Occlusal Stabilization Splint
timeFrame: From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.
measure: Number of Participants with Osteophyte by magnetic resonance imaging
timeFrame: At baseline and Month 12.
measure: Number of Participants with joint surfaces flattening by magnetic resonance imaging
timeFrame: At baseline and Month 12
measure: Number of Participants with Subchondral Geode by magnetic resonance imaging
timeFrame: At baseline and Month 12
measure: Disc Position by magnetic resonance imaging
timeFrame: At baseline and Month 12
measure: Number of Participants with pain in masseter muscle by digital palpation
timeFrame: From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.
measure: Number of Participants with pain in Temporal muscle by digital palpation
timeFrame: From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.
measure: Number of Participants with pain in Medial Pterygoid Muscle by digital palpation
timeFrame: From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.
measure: Number of Participants with pain in digastric Muscle by digital palpation
timeFrame: From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.
measure: Number of Participants with pain in Genihyoid Muscle by digital palpation
timeFrame: From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.
measure: Number of Participants with pain in Mylohyoid Muscle by digital palpation
timeFrame: From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
Study officials:
affiliation: Universidad Complutense de Madrid
name: Jorge Cano Sánchez
role: STUDY_DIRECTOR
affiliation: Universidad Complutense de Madrid
name: Julian Campo Trapero
role: STUDY_DIRECTOR
affiliation: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
name: Mario Fernando Muñoz Guerra
role: STUDY_DIRECTOR
affiliation: Universidad Complutense de Madrid
name: Oscar Gabriel Castaño Joaqui
role: PRINCIPAL_INVESTIGATOR
References:
citation: Montero-Martin J, Bravo-Perez M, Albaladejo-Martinez A, Hernandez-Martin LA, Rosel-Gallardo EM. Validation the Oral Health Impact Profile (OHIP-14sp) for adults in Spain. Med Oral Patol Oral Cir Bucal. 2009 Jan 1;14(1):E44-50.
citation: Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994 Mar;11(1):3-11.
citation: Shi Z, Guo C, Awad M. Hyaluronate for temporomandibular joint disorders. Cochrane Database Syst Rev. 2003;(1):CD002970. doi: 10.1002/14651858.CD002970.
citation: Wilkes CH. Internal derangements of the temporomandibular joint. Pathological variations. Arch Otolaryngol Head Neck Surg. 1989 Apr;115(4):469-77. doi: 10.1001/archotol.1989.01860280067019.
citation: Castano-Joaqui OG, Cano-Sanchez J, Campo-Trapero J, Munoz-Guerra MF. TMJ arthroscopy with hyaluronic acid: A 12-month randomized clinical trial. Oral Dis. 2021 Mar;27(2):301-311. doi: 10.1111/odi.13524. Epub 2020 Jul 25.