nilateral condylar mandibular fractures: Conservative treatment vs. open reduction and internal fixation. A multi-centre prospective study
Completed
- Conditions
- 10005944condylar neck or base fracture of the mandiblefracture of the mandible10017322
- Registration Number
- NL-OMON45588
- Lead Sponsor
- MC Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 75
Inclusion Criteria
- 18 years or older.
- Unilateral condylar mandibular fracture (neck and/or base), with or without other fractures of the mandible, with or without injury of the front teeth, caused by trauma.
- Dislocation of this fracture, with or without bone contact, on CT-scan.
- With dysocclusion.
Exclusion Criteria
- No informed consent.
- Not able to undergo surgery because of comorbidity.
- Not able to understand the Dutch language.
- Legally incapable
- Mid-face fractures, except unilateral fractures of the zygoma.
- Pregnancy
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameters are: VAS-score in millimetres, Mixing ability test in<br /><br>pixels, Clinical examination of the mandible (laterotrusion, protrusion,<br /><br>maximal opening of the mouth -interincisal distance-, deviation of the chin<br /><br>when opening) in millimetres, outcome of the SF-36 questionnaire (continuous),<br /><br>outcome of the MFIQ questionnaire (continuous).</p><br>
- Secondary Outcome Measures
Name Time Method