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THE JOURNAL OF PROSTHETIC DENTISTRY

A pilot study comparing the efficacy of hard and soft stabilizing appliances in
treating patients with temporomandibular disorders
Craig A. Pettengill, DDS,a Maurice R. Growney, Jr., DDS,b Robert Schoff,
DDS,c and Christian R. Kenworthy, DDSd
Center for Temporomandibular Disorders and Orofacial Pain, University of
California-San Francisco, San Francisco, Calif.
Statement of problem. Soft and hard stabilizing appliances have been used to treat temporomandibular
disorders. No data exist to suggest whether a hard or soft appliance is beneficial.

Purpose. This study compared soft and hard acrylic resin stabilizing appliances in the reduction of
masticatory muscle pain in patients with temporomandibular disorders.
Materials and methods. Twenty-three patients with at least one clinical sign from the list of diagnostic
subgroups of temporomandibular disorders were alternately assigned a hard or soft appliance for temporomandibular disorder treatment. No other temporomandibular disorder treatment (self-care, physical
therapy, biofeedback, or muscle or joint injections) was rendered. Each patient was seen by two dentists at
each visit. One dentist initially fabricated the appliance and adjusted the appliance on each visit and an
examining dentist examined the patient each visit and recorded signs of temporomandibular disorders. The
appliance material (soft or hard) was not disclosed to the examining dentist, only to the dentist who
fabricated and adjusted the appliance. Patients were examined and appliances were adjusted every 2 to 3
weeks for a minimum of 10 weeks. Masticatory muscles were palpated and charted on each visit. Data were
analyzed and subjected to nonparametric Mann-Whitney test.
Results. Eighteen of the initial 23 patients, 7 in the hard appliance group and 11 in the soft appliance
group finished the study over a 10- to 15-week period. Soft and hard appliances performed the same in
reduction of masticatory muscle pain.
Conclusion. This study suggests, based on the limited number of participants, that soft and hard
stabilizing appliances may be equally useful in reducing masticatory muscle pain in short-term appliance
therapy. (J Prosthet Dent 1998;79:165-8.)

CLINICAL IMPLICATIONS
Hard appliances have traditionally been used for the treatment of temporomandibular disorders and orofacial pain. This pilot study indicated that a hard or soft acrylic
resin appliance may be useful in the treatment of masticatory muscle pain.

crylic resin interocclusal appliances have been

used in dentistry for the management and treatment of
temporomandibular disorders (TMDs).1-4 TMDs are a
group of problems characterized by temporomandibular joint (TMJ), facial, cervical and/or head pain, joint
noises, and limited range of mandibular motion.5 The
1996 Technology Assessment Conference on the Management of TMD sponsored by the National Institute
for Dental Research, in collaboration with the National
Institutes of Health, recommended conservative, reversible treatment that includes stabilization appliance
therapy (also known as orthotic appliances, splints,
interocclusal appliances, and a host of other names).6
Appliances have been used with the goals of altering
a

Assistant Clinical Professor; and Private Practice, San Jose, Calif.

Assistant Clinical Professor; and Private Practice, San Francisco, Calif.
c
Private Practice, Redding, Calif.
d
Graduate Student in Orthodontics, Mayo Clinic, Rochester, Minn.
b

FEBRUARY 1998

occlusal relationships, redistributing occlusal forces, preventing wear and mobility of teeth, reducing bruxism
and other parafunctional habits, repositioning the
condyle, and treating masticatory muscle pain.5 The
dental profession agrees that TMD appliances for the
treatment of masticatory muscle pain are clinically effective.3,7 Hard acrylic resin appliances have consistently
been shown to be effective.8-11 However, they have been
ineffective in reducing muscle pain in at least one study12
and in another study, that they are no better than placebo.13 On the other hand, investigations have shown
that soft appliances are effective for the reduction of
muscle pain,14-16 TMJ clicking,15 and headache pain.17
Two negative studies exist for the usage of soft occlusal appliances. Soft splints were shown to increase
pain with subjective responses in an uncontrolled study18
and were shown to increase nocturnal electromyographic
recordings compared with hard splints in another study.19
No scientific data exist to suggest whether a hard or
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Fig. 1. Summary of gender, appliance type, and diagnosis.

soft appliance is more beneficial. This leaves the clinician to rely on the observational data offered by their
dental education or continuing education, information
from fellow colleagues, and personal clinical experiences
when deciding which appliance or combination of appliances to use to treat their patients with TMD.
The purpose of this pilot study was to establish a
double-blind method to evaluate the efficacy of hard
versus soft stabilizing appliance therapy. This was performed by comparing the reduction of muscle pain in
patients diagnosed with at least one clinical sign from a
list of diagnostic subgroups of TMD. This list of subgroups included myofascial pain, TMJ inflammation, and
disk displacement with reduction.5

MATERIAL AND METHODS

Twenty-three patients seeking care at the UCSF Center for TMD and Orofacial Pain were examined and accepted into the study. They met the following inclusion
criteria from the 1993 research diagnostic criteria20:
1. A TMD diagnosis from the following list of TMD
diagnostic subgroups; myofascial pain, disk displacement
with reduction, osteoarthritis, and TMJ inflammation
(more than one was acceptable).
2. Subjects were over the age of 18 years old.
3. Subjects agreed to attend all follow-up visits (minimum five) for an examination and splint adjustment.
Patients were excluded from the study if they could
not keep all follow-up visits or if they had, in addition to
a TMD diagnosis, additional systemic diagnoses such as
fibromyalgia or rheumatoid arthritis. The subjects were
assessed for baseline measurements by two examiners.
If the patients met the inclusion criteria, they were alternately assigned a soft or hard appliance treatment
group (Fig. 1) by a staff member who did not have any
knowledge of the TMD diagnosis. None of the patients
received any other TMD treatment or pharmacotherapy
during the study.
Subjects in both appliance groups had maxillary and
mandibular impressions taken in irreversible hydrocolloid and mounted on an articulator with a face-bow transfer and centric relation record. Hard stabilizing appliances were made on the maxillary cast by opening the
articulator pin 2 mm in the anterior region and adding
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acrylic resin on the upper cast to make a maxillary stabilizing appliance with anterior disclusion and even posterior contacts.
Subjects assigned to the soft appliance group received
a full-coverage soft splint fabricated from their maxillary cast that was adjusted to provide complete occlusal
coverage with even interarch contacts and anterior
disclusion. These soft appliances were vacuum-formed,
using a sheet of 2 mm thickness soft vinyl, made from a
centric relation mounting, and adjusted in the mouth
on initial placement. Patients were instructed to wear
their appliance only while sleeping.
The patients were examined initially and on each subsequent visit by one of two dentists who had no knowledge of the type of appliance being used. A separate dentist was used to take initial impressions, fabricate and place
the appliance, and adjust the appliance on all the subsequent visits. Thus each patient underwent a splint adjustment and an examination every visit with two dentists, an
appliance fabricating and adjusting dentist, and an examining dentist. On each subsequent appointment after initial appliance placement, the splint was adjusted or appeared to be adjusted for approximately 20 to 25 minutes. It was important to render the same amount of time
adjusting each appliance for all patients. The dentist either altered or appeared to alter the appliance, regardless
of the material used or the need for further adjustment.
This was intended to reduce the placebo effect by avoiding any reinforcement of the potential effectiveness of the
appliance regarding appliance type. At the conclusion of
the splint adjustment, the dentist made certain that the
patient had simultaneous bilateral posterior contact.
The patient was then examined by another dentist and
underwent an identical comprehensive examination, as was
conducted at the beginning of the study. Nine pairs of
muscles were palpated bilaterally by the dentist, which included temporalis deep masseter, superficial masseter, medial pterygoid, sternocleidomastoid, suboccipital, scalenes,
deep posterior cervicals, and trapezius. The dentist recorded
a score of 0 if there was no pain, 1 if there was mild
tenderness, 2 if the muscle was tender or the palpation
was painful, and 3 if there was a provoked response. This
allowed for a total muscle pain score ranging form 0 if the
was no pain on palpation to 54 if there was a provoked
response to palpation of all 18 muscles.
Data from the initial examination and all subsequent
examinations were gathered and compared. The data
were collected, tabulated, and subjected to a nonparametric Mann-Whitney test.
Interrater reliability was tested for the two examining
dentists and in a subsequent assessment of reliability, a kappa
value was between 0.79 and 0.20. The kappa values for
interrater reliability in this study ranged mostly between
0.4 and 0.6, an indication of fair reliability. There were 18
total kappa values in the range of 0.79 to 0.20. Good reliability would have a kappa value between 0.6 and 0.8, fair
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THE JOURNAL OF PROSTHETIC DENTISTRY

Table I. Summary of gender appliance type and age of patients

Female

Soft appliance
Hard appliance
Age range (yrs.)

Male

4
8
23-64

3
3
25-69

40.6
38.5
12

50.6
43.0
6

Total

7
11
23-69

Average age (yrs)

Soft
Hard
Total patients

18

Fig. 2. Splint efficacy over time by type.

reliability between 0.4 and 0.6, and poor reliability between

0.2 to 0.4.21 Reliability testing methods were tested by using a mix of asymptomatic volunteers, leading to difficulty
in achieving excellence in reliability.
Although discussed, the patients were not asked to
evaluate their symptoms on each visit with a visual analog scale or other type of scoring method. This step was
eliminated to decrease the possibility of bias on the part
of the staff administering the scale, the appliance adjusting dentist, and the examining dentists.

RESULTS
Twelve women and six men (n = 18) with an average
age of 42.2 years completed the study (Table I). Five
other patients began the study but failed to return for
three or more splint adjustments and therefore were terminated from the study. The data collected from their
visits were not included in any statistical analysis or anywhere else in this article.
The duration of treatment for each patient was between 10 and 15 weeks. Each follow-up visit was 2 to 3
weeks apart. On the muscle palpation scale of 0-54, the
average standard deviation (SD) pain score before treatment for all patients was 18.9 (SD 12.5). By the fifth
appointment, the conclusion of the study, the average
muscle pain for all patients, regardless of appliance used,
was 2.7 (SD 8.4). The average score 2 weeks after appliance delivery was 10.1 (SD 9.5) with no significant difference between hard (13.3, SD 10.0) and soft
(8.1, SD 9.0) appliances. Likewise, there was no difference by the fifth week between hard (0.7, SD 1.2) and
soft (3.9, SD 10.7) appliances (Fig. 2). The nonparametric Mann-Whitney test revealed that this difference
was not statistically significant (p = 0.99)
Male/female differences in splint efficacy are illustrated in Figure 3. There were no statistical differences
with hard or soft splints and gender. Although not intended, all the patients in the study had at least a TMD
diagnosis in the diagnostic subgroup of myofascial pain.
Some patients had an additional TMD diagnosis along
with myofascial pain, such as TMJ inflammation and disk
displacement with reduction.
FEBRUARY 1998

Fig. 3. Splint efficacy over time by gender.

There was no statistically significant difference in

muscle palpation scores between the hard and soft appliances at each visit. However, one patient who received
a soft appliance had almost no change in muscle palpation scores. This patient had an initial muscle pain score
of 36 and the final muscle pain score was 34. This accounts for the high standard deviation in the soft appliance statistics. Even with this patient, the high pain scores
before and after, and the size of the study, there was no
statistically significant difference between hard and soft
appliances at each visit. If this patient was eliminated
from the final analysis, there would have been almost no
difference between the two appliance types.
A differential drop out rate was not displayed in the
preceding results and should be noted. Of the 23 patients
who started the study, only 18 finished the study by coming to all follow-up visits. The hard splint group had 10
patients start the study and 7 finish. The soft splint group
had 13 patients start the study and 11 finish for a total in
both groups of 18 patients completing the study.

DISCUSSION
Outcome measures in this study suggest that soft and
hard stabilizing appliances resulted in similar resolution
of myofascial (muscle) pain with palpation scores.
The idea of a control group was discussed during the
design of this study but no ethical or valid solution was
found. To have a patient seeking treatment return to
the Center every 2 to 3 weeks to be reexamined and
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rediagnosed but receive no treatment was considered

unethical. To manufacture a placebo appliance was also
considered but may be invalid because as soon as something is placed in the mouth, even if it only touches the
palate, it may effect or alter mandibular position. Thus
this study was designed only to detect the differences
between hard and soft appliance types, not to determine
whether some particular appliance type was superior to
no treatment. A soft appliance was shown to be more
effective than no treatment and self-care methods in a
recent study.16
It has been suggested that soft appliances result in
occlusal changes. Although occlusal changes were not
included in this study, conclusions have been drawn from
other studies regarding occurrence of occlusal changes
with the use of soft appliances.18 However, in recent studies, minimal changes appeared to have occurred.15,16,22
This study is not conclusive because of the sample
size. More patients in an expanded study would be appropriate with an intent and rationale of comparing splint
types with the blinded interrater reliability. Interrater
reliability with kappa values consistently equal or greater
than 0.8 would improve credibility. More studies could
be considered by using mixed samples of maxillary or
mandibular appliance types and soft or hard appliances.
The benefit of soft appliances to reduce muscle symptoms of TMD is that they appear, according to one study,
to be less expensive and easier to fabricate than hard
appliances.23

CONCLUSION
On the basis of the results of this pilot study with a
limited number of participants and fair interrater reliability, either a hard or soft orthopedic appliance may
be used to treat the dimension of muscle pain with equal
efficacy in patients with a diagnosis of TMD.
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Reprint requests to:

DR. CRAIG A. PETTENGILL
1660 WESTWOOD DR.
SUITE E
SAN JOSE, CA 95125-5102
Copyright 1998 by The Editorial Council of The Journal of Prosthetic Dentistry.
0022-3913/98/$5.00 + 0. 10/1/86084

CONTRIBUTING AUTHORS
Jason Pehling, DDS, and Robert Croft, DDS.
former graduate students, Center for Temporomandibular Disorders and Orofacial Pain.

VOLUME 79 NUMBER 2