Hyaluronic Acid Evaluation as Adjuvant to Temporomandibular Joint Arthroscopy

Temporomandibular Joint Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04110587
• Other study ID #: DUROLANE2013
• Status: Completed
• Phase: Phase 4
• Start date: December 10, 2013
• Est. completion date: July 9, 2019

Study information

• Verified date: September 2019
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: July 9, 2019
• Est. primary completion date: July 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Joint Diseases
• Temporomandibular Joint Disc Displacement
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Biological:
• Hyaluronic Acid
1 mL Hyaluronic Acid Injection (20 mg/mL, 7000 KDa) at the end of arthroscopy .

Procedure:
• Temporomandibular Joint Arthroscopy
Lysis and Lavage

Drug:
• Antibiotic therapy
Amoxicillin / Clavulanic Acid, 1g I.V. (Intraoperative); as well as Amoxicillin / clavulanic acid, 500/125 mg / 8h / 5 days by mouth (Post-operative).
• corticosteroid
Dexamethasone, 4 mg I.V. (Intraoperative)
• Antiinflammatories
Diclofenac 100 mg / 12h / 5 days by mouth (Post-operatively).
• Analgesics
Metamizol 575 mg / 8h by mouth (Post-operatively)

Other:
• Exercise program
Home exercise program

Locations

Country	Name	City	State
Spain	Hospital Universitario de La Princesa	Madrid

Sponsors (3)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid	Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, Zambon SpA

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Montero-Martín J, Bravo-Pérez M, Albaladejo-Martínez A, Hernández-Martín 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. — View Citation

Shi Z, Guo C, Awad M. Hyaluronate for temporomandibular joint disorders. Cochrane Database Syst Rev. 2003;(1):CD002970. Review. Update in: Cochrane Database Syst Rev. 2013;10:CD002970. — View Citation

Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994 Mar;11(1):3-11. — View Citation

Wilkes CH. Internal derangements of the temporomandibular joint. Pathological variations. Arch Otolaryngol Head Neck Surg. 1989 Apr;115(4):469-77. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.
Secondary	Symptoms Duration Mean (Months)	symptoms duration mean reported by the participants	At baseline
Secondary	Number of Participants with chondromalacia	arthroscopic finding	During intervention
Secondary	Number of Participants with synovitis	arthroscopic finding	During intervention
Secondary	Irrigation Volume Mean (cc)	average irrigation fluid used during intervention	During intervention
Secondary	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.
Secondary	Number of Participants with Osteophyte by magnetic resonance imaging	radiographic finding in jaw condyle	At baseline and Month 12.
Secondary	Number of Participants with joint surfaces flattening by magnetic resonance imaging	radiographic finding in jaw condyle or temporal bone	At baseline and Month 12
Secondary	Number of Participants with Subchondral Geode by magnetic resonance imaging	radiographic finding in jaw condyle	At baseline and Month 12
Secondary	Disc Position by magnetic resonance imaging	No Displacement, Disc Displacement with Reduction, Disc Displacement without Reduction	At baseline and Month 12
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.