A randomised placebo-controlled trial in the management of ostheoarthritis of the temporomandibular joint for arthrocentesis with additional dexamethasone versus arthrocentesis alone.

A randomised placebo-controlled trial in the management of ostheoarthritis of the temporomandibular joint for arthrocentesis with additional dexamethasone versus arthrocentesis alone. - The efficacy of additional dexamethason for treatment of ostheoarthritis.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30205

Enrollment

Registered

2006-12-13

Start date

2006-11-01

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

joint pain ostheoarthritis

Interventions

Group A receives arthrocentesis, plus lavage with 1,0 ml (concentration 20 mg/ml) dexamethason. Group B receives arthrocentesis, plus lavage with 1.0 ml placebo solution.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Initial therapy not succesful; splint-therapy, soft food diet, NSAID's, physiotherapy . Local anesthetics gives pain relief.

Exclusion criteria

Exclusion criteria: Ankylosis Rheumatoid arthritis Underwent open jaw surgery in the past Pregnancy

Design outcomes

Primary

Measure	Time frame
Pain. The difference in pain before and after the treatment will be measured using the Visual Analog Scale (0 100 mm). In the experimental group the treatment is considered succesful when 90 percent of the patiënts achieve a 30 percent reduction in pain with jaw movement on the VAS scale . In the control group the treatment is considered succesful when 50 percent of the patiënts achieve a 30 percent reduction in pain with jaw movement on the VAS scale.	—

Measure

Time frame

Pain. The difference in pain before and after the treatment will be measured using the Visual Analog Scale (0 100 mm). In the experimental group the treatment is considered succesful when 90 percent of the patiënts achieve a 30 percent reduction in pain with jaw movement on the VAS scale . In the control group the treatment is considered succesful when 50 percent of the patiënts achieve a 30 percent reduction in pain with jaw movement on the VAS scale.

—

Secondary

Measure	Time frame
Mandibular Function Impairment Questionnaire (MFIQ). Difference in units before and after the treatment on the MFIQ scale. The treatment is considered succesfull if there is a minimum reduction of 13 units on the MFIQ scale. The maximum mouth opening (mm) is measured at each folluw up.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)