Biomarker for impaired bone healing of the mandible
- Conditions
- Fracture of the lower jaworthognathic surgery of the lower jaw
- Registration Number
- DRKS00023948
- Lead Sponsor
- Klinik für Mund-, Kiefer- und GesichtschirurgieCharité - Universitätsmedizin Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 2246
Age> 18 years all patients capable of giving consent
(A) a dysgnathic jaw relation in which an elective jaw-displacing procedure is planned in one (lower jaw) or both jawbones.
(B) With a single or double
Mandibular fracture in which a fracture in the
Jaw body (median, paramedian, body,
Jaw angle)
- Age <18 years
- serious and currently existing concomitant diseases including tumor and infectious diseases (e.g. hepatitis, HIV, TBC), severe heart / circulatory / lung / kidney / liver diseases
- severe psychiatric illnesses (e.g. severe depression)
- all clinically critical conditions at the time of the operation (e.g. unstable circulatory conditions)
- Pregnant and breastfeeding patients
- Alcohol, drug addiction
- Persons not legally competent
- Participation in another clinical trial within 30 days of the end of the study
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Healing status after 24 weeks post-operatively<br>(delayed healing)<br>The evaluation is carried out using radiological imaging and functional tests. Here, the bony bridging of the fracture gap is primarily taken as a measure of the fracture consolidation.<br>Delayed healing after radiological evaluation is indicated in:<br>a) incomplete fracture healing or no visible osseous consolidation<br>b) The presence of the resorption zone or an incomplete callus formation<br>c) an incomplete bony structure, (only 1-3 cortices are bridged)<br>d) no bony formation (no cortex is bridged)
- Secondary Outcome Measures
Name Time Method