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Marist College
Duration: 36 weeks
Introduction:
Although there are a wide variety of occlusal splints (many are customized by the dentists
prescribing them), they all function in modifying the resting position of the jaw, easing stress on
both the joint and jaw muscles. This study will observe effects of nociceptive trigeminal
inhibition tension suppression system (NTI-tss or NTI), a small pre-fabricated anterior bite stop
which covers (in its most widely used form) the two maxillary central incisors. Since its approval
by the FDA in 2001, however, use of the NTI has been somewhat controversial. There have been
a substantial amount of patient reports attributing a worsening of symptoms and sometimes a
permanent change in occlusion to their NTI orthotic (Jokstad, Mo, & Krogstad, 2005).
Temporomandibular disorders present signs and symptoms similar to other diseases and
conditions, this often can lead to misdiagnoses and incorrect treatments. A common misdiagnosis
is seen in patients presenting with tooth pain. In one particular case study, a patient presented
with pain in the right maxillary first molar. Upon clinical evaluation the dentist found no
indication of a temporomandibular disorder and believed the cause of pain to be odontogenic.
The dentist elected to treat the patient by removing the molar causing the discomfort, an
irreversible treatment. Upon removal of the first maxillary molar, the patient's pain continued
and was located at the second maxillary molar. The patient was not diagnosed with a
temporomandibular disorder until the second molar was removed and the pain persisted (Farella,
2003). The similarity of temporomandibular disorders to other diseases has resulted in numerous
instances in which a TMD is misdiagnosed as lyme disease, fibrosarcoma, neurological
disorders, and general tooth pain. The frequency of temporomandibular disorder misdiagnosis
has caused a shift from clinical diagnosis to the use of MRIs to diagnose this disorder. The MRI
provides valuable information regarding disc positioning and muscle strength/function.
The objectives of this proposed study are: 1) To determine how often the nociceptive
trigeminal inhibition (NTI) anterior repositioning splint recaptured an anteriorly displaced TMJ
disc. 2) To determine whether there is a threshold degree of displacement above which the disc
could no longer be recaptured using an NTI splint. 3) To determine if the NTI is successful with
reducing pain, discomfort, and other common symptoms associated with TMD. There are nearly
10 million Americans suffering from TMD, some of which only have access to treatment options
that do not directly cater to their needs. By determining the effectiveness of NTIs ability to
recapture anteriorly displaced TMJ discs and its ability to reduce pain, we expect to gain a better
understanding of which patients may be good candidates for this treatment and which patients
may not. We hope this knowledge will prevent the worsening of symptoms many patients have
reported from using the NTI splint.
Specific Aims:
Our long-term goal is to avoid prescription of the NTI in patients who may not benefit from use
or are likely to experience a worsening of symptoms. The overall objective of the study is to
better understand the ability of the NTI splint to recapture an anteriorly displaced TMJ disc and
to reduce pain in patients using the splint while sleeping. The central hypothesis motivating this
research is that the NTI splint is incapable of recapturing discs beyond a specified degree of
displacement and has a high risk of worsening symptoms in patients whose discs are not
recaptured. The rationale behind the study is that understanding the NTIs success rate of
recapture and pain reduction in specific cases, which is currently unknown, is critical to
prescribing proper treatment of TMD patients.
Aim 1: To establish the extent to which an NTI anterior repositioning splint is successful
in reducing the degree of TMJ disc displacement
Aim 3: To identify the effect the NTI anterior repositioning splint has on occlusion
Aim 4: To determine whether the NTI anterior repositioning splint use results in a
reduction of patient pain level
We will accomplish this by having patients evaluate pain level and frequency of
TMD associated symptoms on a questionnaire
Approach:
To ensure that age does not have a significant effect on the ability for disc recapturing
subjects aged 18-30 years old will be recruited. This age range was selected because the
musculoskeletal system reaches its peak condition in the late 20s and early 30s (Hurd, 2014).
After this time, the functioning of musculoskeletal system slowly begins to decrease as
individuals age. Older subjects present potential confounding variables that would result in
incorrect conclusions to be drawn regarding disc displacement and recapture. In order to be
included in the study subjects must present with a documented diagnosis of anteriorly displaced
TMJ discs. For the control group, subjects must have no history of TMD. Furthermore, the
control group will be assessed for the potential to develop a TMD. To assess these risks, patients
will be asked questions regarding teeth grinding, the pressure placed on the jaw in a resting
position, and other factors. Subjects that answer yes to any potential risk factor will be excluded
from the study. Because MRI testing will lend the most significant data, patients will be
excluded if they were unwilling to undergo an MRI test. Subjects will also be excluded if they
have undergone any surgery relating to the TMJ region.
75 subjects with varying degrees of TMJ disc displacement and complaining of at least
two TMD-associated symptoms (and of course, who do not meet exclusion criteria detailed
above) will be fitted for an NTI splint customized to their personal bite during an initial dental
visit. Study subjects will be instructed to wear their splint for at least 8 hours a night. Subjects
will be advised to remove the splint while eating, however this should not be an issue because it
is recommended that the splint is worn during sleep. A limitation to this requirement is the
potential for subjects to not adhere to the 8 hour requirement. To adjust for this limitation,
subjects will be given a questionnaire and the conclusion of the study. Among these questions,
patients will be asked to rate how well they adhered to the studys protocols. Specifically,
patients will be asked on average, how many hours a day would you estimate you had your NTI
splint in? Based on the results of this questionnaire, the reliability of certain data points are
subjected to change. However, this should not have a significant impact on the conclusions
because a relationship can be drawn from the time spent with the NTI splint and the degree of
disc recapture.
Subjects will also undergo occlusion measurements before the initiation of the study and
at 6 week intervals for 36 weeks. Occlusion without orthotic will be measured using a T-Scan,
which measures the level of force and timing of when the bite comes together. The software's 2D
and 3D tooth contact data specifies each tooth and the force level exerted on that tooth during
occlusion. Data drawn from occlusion measurements at six week intervals will allow for
conclusions regarding how the NTI affects natural occlusion (occlusion without the splint
inserted). It is expected that the occlusion measurements will indicate that NTI splints change the
natural occlusion of the patient.
The use of the NTI and its ability to reduce pain will be measured via participant
questionnaires. Questionnaires will provide a 1-10 pain rating and a 1-4 frequency rating for a
number of symptoms associated with TMD including jaw pain, neck pain, ear pain, facial pain
and migraine headaches. Questionnaires will be handed out at the initiation of the study, at each
six week interval during the subjects occlusion measurements, and at the conclusion of the study.
A limitation of this measurement is that the pain ratings are subjective, what one patient may
consider a ten on the pain scale another patient may consider the same pain only to be a seven on
the pain scale. While this certainly limits the ability to draw qualitative conclusions, it will still
allow qualitative conclusions to be drawn. Specifically, is the NTI splint capable of reducing
pain and symptoms of TMD across all study subjects?
It has been shown that clinical diagnoses of TMJ disc displacement have an accuracy of
43-75% (Gokalp, 2000), therefore the most important data will be obtained using MRI testing.
Baseline measurements of TMJ disc displacement will be measured using MRI testing. Subjects
will be imaged with their mouths in the open and closed positions at the start of the study and at
the conclusion of the study. Each subject will undergo MRI imagining when the mouth is in a
neutral position and closed. To obtain imagining for the mouth open, patients will be asked to
gently bite down on a rod with a diameter of 4cm. The rod will be coated in rubber to prevent
discomfort when biting. Study subjects that are incapable of adhering to the mouth open criteria
will be excluded from the study. MRI will scan the sagittal plane and the transverse plane of the
TMJ in the open and closed positions. At baseline measurements, the disc displacement will be
categorized into two groups: 1) Partial displacement: The angle of the disc relative to normal
disc positioning is between 10-30 degrees. 2) Full displacement: the angle of the disc relative to
normal positioning is greater than 30 degrees. The angle between the two is how the
displacement will be measured (Figure 2). To determine the normal values for disc positioning,
subjects without TMD will undergo an MRI. The positioning of the disc relative to the condyle
and the temporal bone will be collected and averaged. To measure the average disc positioning,
two lines will be drawn on the posterior and anterior aspect of the disc. From where the two lines
intersect within the center of the condyle, a third line will be drawn from the intersection that
splits the disc evenly. This third line will be used as the normal disc positioning measurement,
(Figure 1). The same approach will be used to measure the central axis of the displaced disc. In
order to effectively measure the angle of the TMJ disc, a radiologist will be on hand to assist in
pointing out structures and making measurements. The use of a radiologist will allow for the
generation of accurate data.
It is expected that the pain and symptoms associated with TMD will decrease as the study
progresses. This data will be drawn from the questionnaires handed out during the interval
occlusion measurements. There is limited qualitative data that can be drawn from these
questionnaires including pain levels and excluding number of symptoms. However, this data will
provide useful information regarding the ability of NTI splints to reduce the pain and the
symptoms associated with TMD.
The most important data, however, will be drawn from the angle of TMJ discs at
the initiation of the study and at the studys conclusion. It is expected that the use of NTI splints
will allow for disc recapture in some cases, but not all. NTIs will allow for TMJ disc recapture
because it reduces the tension of the muscles that work in jaw opening and closing resulting in
less pressure placed on the TMJ disc. However, it is unclear the degree of disc recapture that will
be associated with NTIs. Certainly it is expected that the greater the angle of the disc results in
less of a chance to recapture the disc.
Literature Cited:
Alpaslan GH & C Alpaslan (2001). Efficacy of temporomandibular joint arthrocentesis with and
without injection of sodium hyaluronate in treatment of internal derangements. Journal of Oral
and Maxillofacial Surgery, 59(6), 613-618.
Farella, M., Michelotti, A., Gargano, A., Cimino, R., & Ramaglia, L. (2002). Myofascial Pain
Syndrome Misdiagnosed as Odontogenic Pain: A Case Report. Cranio, 20(4), 307-311.
doi:10.1080/08869634.2002.11746224
Gokalp, H. (2000). The changes in temporomandibular joint disc position and configuration in
early orthognathic treatment: A magnetic resonance imaging evaluation. The European Journal
of Orthodontics, 22(3), 217-224. doi:10.1093/ejo/22.3.217
Hurd, R., Zieve, D., & Ogilvie, I. (2014, September 14). Aging changes in the bones - muscles -
joints: MedlinePlus Medical Encyclopedia. Retrieved November 25, 2016, from
https://medlineplus.gov/ency/article/004015.html
Jokstad A, A Mo, & BS Krogstad (2005). Clinical comparison between two different splint
designs for temporomandibular disorder therapy. Acta Odontologica Scandinavica, 63(4),
218-226.
Rao, V. M., Liem, M. D., Farole, A., & Razek, A. A. (1993). Elusive "stuck" disk in the
temporomandibular joint: Diagnosis with MR imaging. Radiology, 189(3), 823-827.
doi:10.1148/radiology.189.3.8234710
Sato S, M Sakamoto, H Kawamura, K Motegi (1999). Long-term changes in clinical signs and
symptoms and disc position and morphology in patients with nonreducing disc displacement in
the temporomandibular joint. Journal of Oral and Maxillofacial Surgery, 57(1), 23-29.
Cost of dental checkup/occlusion measurement every 6 weeks for 36 weeks (6 visits per
patient) = $100 x 6 visits = $600 x 75 patients = $45000
Cost of initial and final MRI scans for TMD subjects (2 total scans for each patient) =
$400 x 2 scans = $800 x 75 patients = $60000
Cost of initial MRI scan for control group = $400 x 75 control subjects = $30000
Tekscan T-Scan dental sensors and supports (6 measurements per patient) = $10 x 6
measurements = $60 x 75 patients = $4500
Salary of researchers = $2000 per week x 1 week of labor (40 hours) = $2000 x 2
researchers = $4000