Arthrocentesis as initial treatment of arthropathy of the temporomandibular joint.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25474

Enrollment

Registered

2008-10-23

Start date

2009-01-09

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Arthropathy of the Temporomandibular Joint

Interventions

Patients assigned to arm 1 undergo an arthrocentesis procedure. The procedure is done under local anesthesia of the TMJ and takes place in a closed room under controlled conditions (prepared dental op

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age over 18 yrs 2. Pain in the TMJ 3. Complaints that persist after treatment with NSAID (Ibuprofen 3 x 600 mg dd, 2 wks) 4. Local anaesthesia of the TMJ yields alleviation of pain complaints

Exclusion criteria

Exclusion criteria: 1. Bony ankylosis of the TMJ 2. Reumatoid arthritis 3. History of TMJ surgery 4. Incompetence to speak the Dutch or English language 5. Pregnancy

Design outcomes

Primary

Measure	Time frame
Main outcome measure is reduction of pain in the TMJ (0 – 100 mm VAS). Furthermore, a cost-utility analysis will be performed with the QALY (Quality Adjusted Life Years) as primary outcome measure. The VAS pain scale (0-100) will be used as primary outcome measure of the cost-effectiveness analysis. QALYs used in the additionally planned cost-utility analysis will be derived from EQ-5D [EuroQoL group, 1990] (10) results assessed in the context of the current study.	—

Measure

Time frame

Main outcome measure is reduction of pain in the TMJ (0 – 100 mm VAS). Furthermore, a cost-utility analysis will be performed with the QALY (Quality Adjusted Life Years) as primary outcome measure. The VAS pain scale (0-100) will be used as primary outcome measure of the cost-effectiveness analysis. QALYs used in the additionally planned cost-utility analysis will be derived from EQ-5D [EuroQoL group, 1990] (10) results assessed in the context of the current study.

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Secondary

Measure	Time frame
Additional outcome measures are: - mandibular function (scored as numerical outcome of validated MFIQ and measurements (mm) of the mandibular range of motion) - Oral Health related quality of life (OHIP) - Quality of life in general (RAND - 36) - bony changes (scored as ordinal variable on panoramic, transpharyngeal, and transcranial Xrays). Possible confouders may be psychosocial factors related with chronic pain. These are scored with SCL-90.	—

Measure

Time frame

Additional outcome measures are: - mandibular function (scored as numerical outcome of validated MFIQ and measurements (mm) of the mandibular range of motion) - Oral Health related quality of life (OHIP) - Quality of life in general (RAND - 36) - bony changes (scored as ordinal variable on panoramic, transpharyngeal, and transcranial Xrays). Possible confouders may be psychosocial factors related with chronic pain. These are scored with SCL-90.

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Contacts

Public ContactL.M. Vos

University Medical Center Groningen PO Box 30001

l.m.vos@kchir.umcg.nl+31 (0)50 3613841

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)