The aim of the present study is to demonstrate the effectiveness of screw IMF.
ID
Source
Brief title
Condition
- Bone and joint injuries
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Postoperative pain will be monitored by using a Visual Analogue Scale and a
7-points scale.
Secondary outcome
Occlusion, quality of life, gingival status, parodontium status, maximal mouth
opening and fracture healing will be monitored.
Background summary
Intermaxillary fixation (IMF) is used in the treatment of mandibular fracture.
Two techniques, using arch bars or screws, are currently used for IMF. Whereas
arch bars are in general the primary choice, screws for intermaxillary fixation
are used increasingly. These techniques have never been compared. There is lack
of evidence concerning the treatment outcome and complications using screws as
IMF. We hypothesize that screw IMF is equally effective compared to arch bar
IMF but accompanies less complications.
Study objective
The aim of the present study is to demonstrate the effectiveness of screw IMF.
Study design
Prospective randomized clinical trial. Blinding of the patients, physicians and
observers is not possible.
Intervention
One group will be treated with arch bar IMF. The other patient group will be
treated with screw IMF. The IMF will remain in situ for 6 weeks. All fractures
will be fixated with mini-plates if needed.
Study burden and risks
The postoperative follow-up will be the same as the treatment protocol for
mandibular fractures as used in our department, i.e. every week postoperatively
during 6 weeks. The patients have to ffil in a questionnaire concerning the
quality of life and pain 1 week, 3 weeks and 6 weeks postoperatively. During
their visit the gingival and parodontium status will be measured. All
complications will be registered, e.g. infection, fracture of the screw,
gingivitis, periodontitis, bone loss, damage of the roots and loss of the
screws.
Postbus 7057
1007MB Amsterdam
NL
Postbus 7057
1007MB Amsterdam
NL
Listed location countries
Age
Inclusion criteria
patients with mandibular fracture combined with or without collum fracture, patients with one collum fracture with dislocation, patients should be between 18-65 years old, patients should have given their written informed consent.
Exclusion criteria
not being able to give informed consent, known chronic pain syndrome, mental retardation, psychiatric abnormality, malignant disease.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL28831.029.09 |