A minimum invasive technique for patients with jaw joint dysfunction

Evaluation of viscosupplementation and arthrocentesis associated with mandibular manipulation in the treatment of degenerative temporomandibular joint disease - a randomized clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN48852162

Enrollment

Registered

2022-11-02

Start date

2019-03-10

Completion date

Unknown

Last updated

2023-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative joint disease Musculoskeletal Diseases

Interventions

Current interventions as of 05/04/2023: Patients are randomly assigned in a 1:1 ratio. A random allocation sequence is performed using a randomization program (http://www.randomizer.or

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Both sexes 2. 18 to 70 years of age 3. Previous history of TMJ blocking 4. Acute or chronic temporomandibular disorder (TMD) uni- or bi-lateral

Exclusion criteria

Exclusion criteria: 1. Exclusively muscular TMD 2. Clinical history of TMJ fracture, ankylosis or surgery 3. Patients undergoing other kind of treatment for articular TMD

Design outcomes

Primary

Measure	Time frame
The efficacy and safety of mandibular manipulation associated with viscosupplementation of the temporomandibular jaw, measured using: 1. Overall TMJ pain assessment with the visual analogue score (VAS) at baseline, 1 month and 12 months after treatment 2. Safety assessed by recording side effects throughout the study	—

Secondary

Measure	Time frame
1. Masticatory muscle pain measured using the visual analogue score (VAS) at baseline, 1 month and 12 months after treatment 2. Mandibular range of motion is measured in millimeters with a Therabite Ruler in maximum opening position without pain at baseline, 1 month and 12 months after treatment 3. TMJ degenerative joint images on CT scan evaluated by a trained and calibrated blinded researcher at baseline and 12 months after treatment 4. TMJ disc position on MRI evaluated by a trained and calibrated blinded researcher at baseline and 12 months after treatment 5. Oral health-related quality of life measured using the Oral Health Impacts Profile (OHIP-14) at baseline, 1 month and 12 months after treatment	—

Measure

Time frame

1. Masticatory muscle pain measured using the visual analogue score (VAS) at baseline, 1 month and 12 months after treatment 2. Mandibular range of motion is measured in millimeters with a Therabite Ruler in maximum opening position without pain at baseline, 1 month and 12 months after treatment 3. TMJ degenerative joint images on CT scan evaluated by a trained and calibrated blinded researcher at baseline and 12 months after treatment 4. TMJ disc position on MRI evaluated by a trained and calibrated blinded researcher at baseline and 12 months after treatment 5. Oral health-related quality of life measured using the Oral Health Impacts Profile (OHIP-14) at baseline, 1 month and 12 months after treatment

—

Countries

Portugal

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026