To compare open and closed treatment of fractures of the manibular condyle. With special attention to the subjective experience of temporomandibular joint dysfunction in patients.
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference between open and closed reduction calculated by the Mandibular
Function Impairment Questionnaire (MFIQ) (Stegenga et al. (1993) en Kropmans et
al. (1999)).
Secondary outcome
I. Questionnaires
a. General health questionnaire
b. Research Diagnostic Criteria for Temporomandibular Disorders: RDC/TMD
c. Oral Health Impact Profile: OHIP-14
d. Symptom Checklist: SCL-90 (somatisation, sleep, depression, anxiety)
II. Anatomical reduction of the mandibular condyle (radiographic assessment)
III. Function temporomandibular joint (functional assessment)
IV. Neurological functions (neurological assessment)
V. Costs of both interventions and cost effectiveness
Background summary
Fractures of the mandibular condyle are common injuries that account for
between 25% and 35% of all mandibular fractures. Treatment options for
fractures of the mandibular condyle consist of either closed reduction or open
reduction with internal fixation (ORIF).
Several studies have demonstrated advantageous clinical results with closed
treatment of condylar fractures. Some studies however have shown complications
of the closed reduction; including malocclusion, particularly open bites,
reduced posterior facial height and facial asymmetry, chronic pain and reduced
mobility.
Open reduction of the condylar fractures has been recommended in selected cases
and different indications have been proposed. As well as the closed reduction,
the open approach has not infrequently been associated with complications; a
cutaneous scar and temporary paralysis of the facial nerve.
At present a consensus regarding the most appropriate method for the management
of fractures of the mandibular condyle is missing. There is a lack of high
quality evidence for the effectiveness of either approach. Most of the studies
on this subject have been retrospective case series using a single approach
rather than a comparison of the two techniques. Further research, comparing the
two treatmen options is required to be able to make an informed choice between
the open and closed reduction.
The aim of this prospective study was to compare open and closed treatment of
fractures of the manibular condyle. With special attention to the subjective
experience of temporomandibular joint dysfunction in patients.
Study objective
To compare open and closed treatment of fractures of the manibular condyle.
With special attention to the subjective experience of temporomandibular joint
dysfunction in patients.
Study design
Randomised clinical trial with follow up examinations at 2 weeks, 6 weeks, 6
months and 12 months.
Intervention
Open reduction
- Internal fixation (ORIF = titanium plates)
- Decisions about individual surgical procedures and surgical approaches are
left to the surgeon
- No maxillomandibular fixation
- Physiotherapy is allowed
Closed reduction
- Maxillomandibular fixation (with steel wires or firm elastics for a maximum
of 14 days)
- Physiotherapy is allowed
Postoperative instructions regarding mouth opening, no rinsing in the first 24
hours and a full liquid diet, are given to all patients.
Study burden and risks
Number of visits
- Follow up examinations at 2 weeks, 6 weeks, 6 months and 12 months.
Physical examination
a. Functional assessment: temporomandibular joint
b. Neurological assessment
Questionnaires
1. Mandibular Function Impairment Questionnaire (MFIQ)
2. Remaining:
a. General health questionnaire
b. Research Diagnostic Criteria for Temporomandibular Disorders: RDC/TMD
c. Oral Health Impact Profile: OHIP-14
d. Symptom Checklist: SCL-90 (somatisation, sleep, depression, anxiety)
Possible complications
Closed reduction:
Malocclusion, particularly open bites, reduced posterior facial height and
facial asymmetry, chronic pain and reduced mobility.
Open reduction:
Bleeding, infection, cutaneous scar and temporary paralysis of the facial
nerve.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
age of patients older than 18 years
fracture of mandibular condyle (confirmed on X-ray)
presentation within one week of injury
Exclusion criteria
known anatomical abnormality with malocclusion and/or temporomandibular joint dysfunction
insufficient dentition
contraindications for general anaesthesia
mentaly disabled (unable to give informed consent)
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 | NL38030.018.13 |