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Biomarker for impaired bone healing of the mandible

Biomarker for impaired bone healing of the mandible - BioMand

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00023948
Enrollment
2246
Registered
2021-01-12
Start date
2020-09-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Fracture of the lower jaw orthognathic surgery of the lower jaw

Interventions

Group 1: 1. Preoperative blood Analyse<sis 2. Intraoperative collection of fracture hematoma / clot in osteotomy gap 3. Postoperative blood analysis (days 1-3 after surgery) 4. Postoperative X-ray con

Sponsors

Klinik für Mund-, Kiefer- und GesichtschirurgieCharité - Universitätsmedizin Berlin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

MeasureTime frame
Healing status after 24 weeks post-operatively (delayed healing) 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. Delayed healing after radiological evaluation is indicated in: a) incomplete fracture healing or no visible osseous consolidation b) The presence of the resorption zone or an incomplete callus formation c) an incomplete bony structure, (only 1-3 cortices are bridged) d) no bony formation (no cortex is bridged)

Countries

Germany

Contacts

Public ContactJan Voß

Klink für Mund-, Kiefer- und GesichtschirurgieCharité - Universitätsmedizin Berlin

jan.voss@charite.de030450555022

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026