Open versus closed treatment of fractures of the mandibular condyle: A prospective, randomized, multicentre study

Open versus closed treatment of fractures of the mandibular condyle: A prospective, randomized, multicentre study - Treatment of fractures of the mandibular condyle

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47753

Enrollment

Registered

2013-10-17

Start date

2015-11-02

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

fracture mandibular condyle lower jaw fracture

Interventions

Open reduction - Internal fixation (ORIF = titanium plates) - Decisions about individual surgical procedures and surgical approaches are left to the surgeon - No maxillomandibular fixation - Physi

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: age of patients older than 18 years fracture of mandibular condyle (confirmed on X-ray) presentation within one week of injury

Exclusion criteria

Exclusion criteria: known anatomical abnormality with malocclusion and/or temporomandibular joint dysfunction insufficient dentition contraindications for general anaesthesia mentaly disabled (unable to give informed consent)

Design outcomes

Primary

Measure	Time frame
The difference between open and closed reduction calculated by the Mandibular Function Impairment Questionnaire (MFIQ) (Stegenga et al. (1993) en Kropmans et al. (1999)).	—

Secondary

Measure	Time frame
I. Questionnaires a. General health questionnaire b. Research Diagnostic Criteria for Temporomandibular Disorders: RDC/TMD c. Oral Health Impact Profile: OHIP-14 d. Symptom Checklist: SCL-90 (somatisation, sleep, depression, anxiety) II. Anatomical reduction of the mandibular condyle (radiographic assessment) III. Function temporomandibular joint (functional assessment) IV. Neurological functions (neurological assessment) V. Costs of both interventions and cost effectiveness	—

Measure

Time frame

I. Questionnaires a. General health questionnaire b. Research Diagnostic Criteria for Temporomandibular Disorders: RDC/TMD c. Oral Health Impact Profile: OHIP-14 d. Symptom Checklist: SCL-90 (somatisation, sleep, depression, anxiety) II. Anatomical reduction of the mandibular condyle (radiographic assessment) III. Function temporomandibular joint (functional assessment) IV. Neurological functions (neurological assessment) V. Costs of both interventions and cost effectiveness

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)