The main aim of this study is to get insight in postoperative clinical results such as masticatory performance, maximum bite force, maximum mouth opening, pain, mandibular function and patient satisfaction in patients with an alloplastic TJR TMJ (…
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The masticatory performance will be measured by the mixing ability test. It
measures how well a subject can mixe a red-blue wax tablet (size of a
peppermint) by chewing on it.
Secondary outcome
(1) The bite force transducer will be used to measure the maximum bite force
(MBF).
(2) To measure the maximum active and passive range of motion of the jaw
opening, participants will be asked to open their mouth to the maximum and all
measured values will be recorded between the front teeth with a metal ruler.
(3) The Visual Anologue Scale (VAS) will be used to assess the pain level from
score 0 mm 'no pain' to score 100 mm 'worst imaginable pain'. Before
measurements and during chewing, maximum bite force, and maximum mouth opening.
(4) Patients satisfaction with the replacement will be determined using a VAS.
This will be rated between 0 mm 'absolutely dissatisfied' and 100 'completely
satisfied'.
(5) To evaluate subjective impression of daily oral function the mandibular
function impairment questionnaire (MFIQ) will be used.
Background summary
Patients with temporomandibular dysfunction (TMD) are normally treated with
conservative, non-surgical methods. However, if intra-articular disorders are
not responding to conservative therapies, and patients suffer from severe,
chronic temporomandibular joint (TMJ) pathology*s, patients may benefit from
surgery. One of the surgery options that is becoming more popular worldwide is
an alloplastic total joint replacement (TJR) of the TMJ. An alloplastic TJR TMJ
is a surgical option that involves reconstruction of both the mandibular
condyle and temporal bone fossa. Important goals of this surgery include
improvement of mandibular function, reduction of pain and suffering and also
improvement of masticatory performance. Promising results have been documented
including subjective data related to pain, quality of life, the perception of
mandibular function and diet consistency and also about objective data such as
maximum mouth opening (MMO) and maximum voluntary bite force. A recent study
indicated that to the year 2030 there will be an increasing demand for the use
of TJR devices in the United States. Also in Europe there is an increased
demand for the use of TJR TMJ devices. Thus making the outcomes of this
intervention worthy for further evaluations.
To our knowledge objective masticatory performance has not been evaluated in
the literature. Patients with end-stage TMJ pathologies commonly suffer from
impaired masticatory performance and an allplastic TJR TMJ might change this.
Therefore, it is important to evaluate the objective masticatory performance,
to determince how an alloplastic TJR TMJ influences the masticatory system.
Study objective
The main aim of this study is to get insight in postoperative clinical results
such as masticatory performance, maximum bite force, maximum mouth opening,
pain, mandibular function and patient satisfaction in patients with an
alloplastic TJR TMJ (Biomet Microfixation systems). The second aim is to
determine if masticatory performance can be explained by maximum bite force,
maximum mouth opening, pain, and/ or patient satisfaction. It is important to
investigate these outcomes, because it may contribute to a better understanding
of the results and management after replacing the temporomandibular joint.
Study design
Cross-sectional study
Study burden and risks
The objective tests will take at maximum 20 minutes, 5 minutes per objective
test (chewing, maximum bite force, and passive and active maximum mouth
opening). The burden of these tests are minimal for the participents; chewing
20 times on wax, clenching four times as hard as you can on a biteforce
transducer, and to open twice your mouth as wide as possible. The subjective
tests will take at maximum 30 minutes (MFIQ and VAS scales). So in our opinion
the burden is minimal. There are no specific advantages or risks for the
participants in this study, because the physical burden is minimal and so the
consequences for the participants are nihil.
Henri Dunantstraat 1
's Hertogenbosch 5223 GZ
NL
Henri Dunantstraat 1
's Hertogenbosch 5223 GZ
NL
Listed location countries
Age
Inclusion criteria
(1) unilateral or bilateral total joint reconstruction of the temporomandibular joint
(2) absence of postsurgical trauma
(3) signed an informed consent
Exclusion criteria
(1) edentate
(2) patients who don*t speak and understand Dutch or English.
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 | NL65072.028.18 |