The aim of this study is to describe whether anatomical reduction in closed treated unilateral condylar mandibular fracture and objectively measured masticatory performance are related.
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Anatomic parameters:
1. Anatomic position of the fracture on radiologic imaging by means of
comparison after mirroring of the contralateral side in millimetres
(continuous) and degrees (continuous).
2. Occlusion disorder (yes/no).
- Masticatory performance tested with Mixing Ability Test: outcome in
*pixels* (continuous)
Secondary outcome
- Functional parameters:
1. Pain registration with the VAS-score in millimetres (continuous)
2. Clinical examination of the mandible: laterotrusion, protrusion, maximal
opening of the mouth measuring interincisal distance, deviation of the chin
when opening) in millimetres (continuous), tenderness of the TMJ.
- Subjective parameters:
1. RAND36 questionnaire (continuous)
2. MFIQ questionnaire (continuous)
Background summary
The condyle is the most fractured site of all mandibular fractures with a
percentage that varies between 16% and 43%.(Boffano et al. 2015) Management for
condylar mandibular fractures was traditionally conservative or closed
treatment with intermaxillary fixation (IMF). An open approach with internal
fixation (ORIF) became more favourable since the introduction of internal rigid
fixation devices because of better anatomical reduction of the
fracture.(Al-Moraissi and Ellis Iii 2015) In current management there is no
consensus for reaching best treatment outcome. Treatment decision remains
dependant of the surgeon*s experience.(Baker, McMahon, and Moos 1998)(Kommers,
Boffano, and Forouzanfar 2015)
Insufficient anatomical reduction of the facture after closed treatment could
render a clinical functional acceptable result for the patient, although long
term follow-up studies are limited.(Rutges et al. 2007)(Forouzanfar et al.
2013) Functionality is often studied, while functionality does not necessarily
correspond to subjective outcomes for the patient and their quality of
life.(Kommers, van den Bergh, and Forouzanfar 2013) This was also concluded in
other medical fields.(Breek et al. n.d.; Kelly et al. 2005) Additionally, there
is insufficient insight in objectively and subjectively measured masticatory
performance in these patients and which factors influence these outcomes.
This study aims to describe whether objective en subjective outcomes are
related. This could potentially contribute in taking treatment decisions for
condylar mandibular fractures. If conclusive, we will strive to implement
national guidelines.
Study objective
The aim of this study is to describe whether anatomical reduction in closed
treated unilateral condylar mandibular fracture and objectively measured
masticatory performance are related.
Study design
observational cross-sectional study
Study burden and risks
It concerns a one time visit to the clinic of oral and maxillafacial surgery
UMC Utrecht. The patient completes 2 medical questionnaires, gets a CBCT-scan
of the mandible, the mixing ability test is performed, and in the end
examination of the maxillary complex. This will take about 45minutes. The risk
of participation is the risk of one low dose conebeam CT-scan (0.7mSv)
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- Unilateral condylar mandibular fracture (neck and/ or base) between 1996 and 2013
- Closed treatment
- >=18 year of age at time of trauma
- Dysocclusion at time of trauma
- Patients with sufficient Dutch writing and reading skills
Exclusion criteria
- No informed consent
- Legally incapable and/ or (treatment for) psychiatric disease
- Le Fort I, II en/ of III fractures, apart from unilateral fractures of the zygoma
- Pregnancy
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 | NL60070.041.17 |