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Problem
5.1
Inclusion and exclusion
criteria for any RCT that evaluate TMD treatments will contain
specific criteria critical to a particular RCT and more generic
criteria that might be desirable for many RCT's.
A brief comparison
of three proposed RCTs is presented below, together with a partial
list of selected critical inclusion and exclusion criteria. Your
task will be to match the critical inclusion and exclusion criteria
for these RCTs.
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| RCT
C
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| Primary
aim is to evaluate:
| Intra-oral
splint appliance design | A
self-management program for TMD pain | The
efficacy of TMJ arthrocentesis, for TMD patients exhibiting
TMJ pain and significant restriction of jaw function |
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| Arms
of study to compare:
| - A
flat-plane, processed hard acrylic upper intra-oral splint
appliance
- A
soft, pre-formed, patient molded athletic mouth-guard
intra-oral appliance
- No
appliance of any kind
For
all TMD clinic patients who will receive, in addition, the
usual and customary TMD care and are willing to provide
signed, informed consent.
| - Usual
and customary TMD treatment, consisting of generally reversible
treatments, e.g. physio-therapy, NSAIDs, intra-oral splints
- A
self-management program for TMD which educates and instructs
patients in the use of self-care jaw stretching and relaxing
exercises, behavior change strategies for coping with
pain and pernicious oral parafunctional habits, use of
a personal plan for maintaining self-care strategies,
all delivered by a registered dental hygienist, in lieu
of usual and customary care by a dentist
For
TMD clinic cases who:
- Have
psychological status and level of psychosocial functioning
within normal limits
- Have
exhibited persistent TMD-related muscle and/or joint pain
- Are
willing to provide signed, informed consent
| - Arthrocentesis
of the TMJ without usual and customary treatment for TMJ
pain and dysfunction
- Arthrocentesis
combined with usual and customary treatment for TMJ pain
and dysfunction
- Usual
and customary TMJ treatment, alone
For
purposes of this RCT, arthrocentesis is defined as entry
into the joint with a large-needled syringe in order to:
i) lavage the TMJ with a sterile saline solution and, ii)
in combination with an anti-inflammatory steroidal preparation.
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| Primary
outcome measures:
| - Reduction
of TMD-related pain by 50%
- Restoration
of normal vertical range of motion
- At
post-treatment and at one- and two-year follow ups.
| - Reduction
of TMD-related muscle and joint pain by 50%
- No
significant change in level of psychosocial function
- At
post-treatment and at one- and two-year follow ups
| - Reduction
of TMJ pain, at least 50%
- Restoration
of normal vertical range of motion
- Elimination
of TMJ clicking and crepitus sounds
- At
post-treatment, one- and two-year follow ups
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Question
5.1.1
Which criterion would
you deem critical for each RCT? (Click in a box to indicate a
critical criteria. Criteria may appear in more than one RCT.
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