Skip to content

Dental injury caused by intraoperative intermaxillary fixation. A prospective comparative study of two techniques.

Dental injury caused by intraoperative intermaxillary fixation. A prospective comparative study of two techniques.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00009395
Enrollment
50
Registered
2017-05-09
Start date
2017-01-01
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

S02.6 S02.5

Interventions

Group 1: IMF-screws with pre-drilling In this group the MMF screws are applied after a pilot drilling while open reduction and internal fixation of a fracture of the mandible. Group 2: IMF-screws with

Sponsors

Medartis AG
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: approvability, 4 screws used only during the operation (for spino-mental fixation 2 screws)

Exclusion criteria

Exclusion criteria: missing approvability, mentally ill persons, recall of approval, missing approval, postoperatively left screws

Design outcomes

Primary

MeasureTime frame
Tooth damage by MMF-screws . This parameter is raised by a postoperative X-ray image analysis. The tooth damage are graded in 4 degrees (class 0 = no injury of the tooth root, class 1 = less than 50% of the drill hole in the dentin without pulp involvement, class 2 = over 50% of the drill hole in the dentin without pulp involvement, class 3 = pulp injury).

Secondary

MeasureTime frame
Damage to the periodontium. probing depth (in mm), tooth mobility (I-III), percussion test (painful/not painful), thermal pulp sensibility test (reactive/non-reactive), toothache (yes/no).

Countries

Germany

Contacts

Public ContactStefan Hartwig

Klinik für Mund-Kiefer-Gesichtschirurgie, Charité - Campus Virchow Klinikum

stefan.hartwig@charite.de+49 30 450 555 148

Outcome results

None listed

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