SECTION

EDITOR

sal adjustment therapy for craniomandibular ieal assessment by a double-blind method

disdrders:

P. Tsolka, DipDS, DDS,a R. W. Morris, MSC,~ and H. W. Preiskel, MDS, MSc, FDS,C United Medical and Dental Schools,London, England Fifty-one patients with eraniomandibular disorders were divided in two groups. One group underwent mock occlusal adjustment, the other was treated with adjustments to remove significant slides and non-working side interferences. Both groups received identical counseling. The results show that there was no significant diEerence in the improvements on the signs and symptoms obtained by real or mock adjustments after the first treatment session. (J PROSTHET DENT 1992;68:95764.)

he multifactorial etiology of craniomandibular disorders is generally recognized.lw7Excluding such factors as mechanical derangements of the joint, external trauma, and vascular complications, the unknown and highly controversial roles of malocclusion and psychogenic stress are unresolved.8,g Because the etiology of many craniomandibular disorders (CMDs) is unresolved, a variety of treatment methods have become pop~lar.~~, I1 Some clinicians say that occlusal disharmony is an important causative factor.12-14 Several impressive clinical and experimental studies appear to show a positive correlation between the occlusal factors and dysfunction.15-27 Despite the wide use of occlusal adjustments as an effective method of treatment, there are surprisingly few controlled studies.28-34 Placebo effects can interfere Iwith all methods of therapy that involve splints, occlusal adjustments, and drugs.27,33,35-43Goodman et a140 and Forssell et al.33 suggest that the placebo effect in treatment when occlusal adjustments are employed may account for up to 40 % of the remissions of symptoms. The aims of this study were (1) to evaluate the effects of one dentist’s occlusal adjustment on the signs and symptoms of CMDs by means of clinical assessment, electromyographic (EMG-EM2) and kinesiograph (Myo-tronics Research, Inc., Seattle, Wash.) MKG-Model K6 recordings, and a double blind method; and (2) to compare the results of clinical examinations with the results derived from electromyographic and kinesiograph recordings. This article contains only the results of clinical assessments.

aResearch bLecturer ment. Tonsultant,

Assistant, in Medical Department

Department Statistics,

of Prosthetic Public Health

of Prosthetic

Dentistry.

16/l/41679

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Dentistry. Medicine

Depart-

PATIENTS

AND

METHODS

Over a period of 2 years, 51 patients with craniomandibular disturbances, 44 women and 7 men, 15 to 52 years of age (mean age 31.4 years), referred to the Department of Prosthetic Dentistry and the Department of Oral and Maxillofacial Surgery, were invited to take part in the investigation. The study was accepted by the Ethical Committee of the United Medical and Dental Schools. The criteria for the selection were patients with (1) no clinical or radiographic evidence of organic temporomandibular joint (TMJ) disease; (2) no trismus or “closed lock” (locking without reduction); (3) no psychotropic medication in the previous 2 weeks; (4) no removable prosthesis; (5) posterior occlusal support who demonstrated a malocclusion permitting chairside occlusal. adjustment; and (6) patients with mild and/or severe symptoms from the stomatognathic system. With the aid of random numbers, patients were divided into two groups. The first group was those receiving mock occlusal adjustment at the first treatment session, 23 patients, 19 women and four men ranging in age from 18 to 59 years (mean 30.8; SD 8.1 years). The second group was those receiving real chairside occlusal adjustment made at the first treatment session, 28 patients, 25 women and three men, ranging in age from 15 to 52 years (mean 31.8; SD 11.4 years). Notes concerning the type of adjustments were kept in a closed drawer separate from the treatment records. Apart from this first visit, only the clinician was present during the treatment sessions. Follow-up visits were arranged 10 days after each treatment session. One woman from the placebo group and three from the real treatment group failed to attend the clinical examination after the second treatment session and therefore were dismissed from this study. Eleven of the 51 patients (21.5%) continued with successful splint therapy (stabilization appliances covering

957

TSOLKA,

Table

I. Prevalence

of symptoms

in placebo

and real treatment

group before treatment

AND

MORRIS

and after first session treatment

A Session

B Session

Placebo

Real

Placebo

Real

Symptoms

n

%

n

%

n

%

n

Jaw pain

17 9 22

74 39 95.6 74 26

16 8

51 28.5

14 7 19 13 1

61 30.4 82.6 56.5 4.3

11

39.2

7 15

25 53.5 64.2 11

Face

pain

Weadache* Click

17

6

Lock A, Before treatment. B, Ten days after first *Significant differences

17

61

19

68 43

12

session treatment, real or mock occlusal adjustment. (p < 0.05) between placebo and real treatment group

Table II. Prevalence session treatment

of anamnestic

dysfunction

index

by Helkimo

AiII (severe) AiI (mild)

in the two groups

AiO

(absence)

%

n

%

n

23

100

22 3 3

78.6

10.7 10.7

19 2 2

0

3

before

treatment

and after first

Placebo

Real

n

0

ia

B Session*

Placebo Helkimo index

%

in both sessions.

A Session”

A, Before any treatment. B, Ten days after first session treatment, real or mock occlusal adjustment. *Significant differences (p < 0.05) between placebo and real treatment group

the entire maxillary dentition). The total number of visits for these patients ranged from four to 11. The treatment period ranged from 1 month to 6 months. The continued follow-up time ranged from 12 to 26 months. Clinician number one (PT) examined the patients approximately 10 days after the first type of minor adjustment and after a similar period following any subsequent treatment sessions. Clinician number two (HP) employed bimanual mandibular manipulation, the Dawson method,12 to locate centric relation (CR), and any resulting slide was marked with articulating paper held in Miller forceps (Bausch Dental Co. D5000, Cologne, Germany). Nonworking side contacts were also marked and eliminated as far as possible. Adjustments were aimed at eliminating non-working interferences, and any slide to centric occlusion (CO). The goals were to produce bilateral stability and anterior guidance in protrusion when possible. Patients also received counseling. Patients in the placebo group Were treated in an identical manner, the only difference being that the “adjustments” were carried out with the smooth shank of a bur and the teeth were polished with a rubber cup. The counseling was identical for both groups. For ethical reasons, mock adjustments were not continued in the placebo group after the first treatment session if symptoms persisted. The evaluation and adjustments of the occlusion were under-

958

PREISKEL,

Real

%

n

%

82.6 8.6 8.6

15 9 4

53.6 32.1 14.2

in both sessions.

taken directly in the mouth to reproduce clinical techniques that are most commonly used. Each examination session was carried out by the same examiner 10 days after each treatment session. Clinician number one examined all patients before and after each treatment session in the following ways.

Helping patients to complete special anamnestic questionnaire and psychological test The anamnestic questionnaire included questions about the sounds of the TMJ, luxation and locking of the TMJ, oral habits, chewing ability, and pain in the face, jaw, and head (intensity, duration, location, description, frequency). To assess the intensity of the pain, a scale from 0 to 5 was used where 0 indicated no pain and 5 was the severest pain imaginable. 44 To assess the severity of click, one cross for mild sound and two crosses for more intense sound were used. The Helkimo45 anamnestic dysfunction index was completed according to the-answers to these questions. The psychological test was a sires3 inventory (SOS), a modification of the Cornell medical index (Department of Psychosocial Nursing, University of Washington, Seattle, Wash.). The SOS consists of 94 items grouped into 10 subscales and a five-point frequency scale instead of the dichotomous response (yes/no). The ten subscales are (I)

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Table

ADJUSTMENT

111. Changes

THERAPY

in symptoms

in both groups Placebo

1 Unchanged

Overall symptoms Headache clicking Locking Pain jaw Pain face

group

Real

2

3 WOEX

%

n

13 10 12 1 9 5

56.5 43.5 52.1 4.3 39.1 21.7

10 9 5 5 8 4

%

n

43.5

0 3 0 0 0 0

39.1

21.7 21.7 34.7 17.3

peripheral manifestations; (2) cardiopulmonary symptoms, (a) symptoms of arousal, (b) upper respiratory symptoms; (3) central-neurological symptoms; (4) gastrointestinal symptoms; (5) muscle tension; (6) habitual patterns; (7) depression; (8) anxiety/fear; (9) emotional irritability; and (10) cognitive disorganization. This test appeared to be useful in assessing the frequency and type of stress response.

erforming a full the craniomandibular

clinical examination system

of

The full clinical examination included examination of the TMJ (visual and palpation assessments), the masticatory and neck muscles (palpation), and the mandibular mobility (measurement of vertical and horizontal overlap and border movements of the mandible). The results constitute the Helkimo clinical dysfunction index.45 This examination also included the occlusion analysis by assessment of dental status. The CR was located with bimanual guidance12 and premature contacts with the mandible retruded were recorded as unilateral or bilateral, anterior or posterior, according to the test subjects tactile sensibility, and they were also identified with articulation paper. Contacts in lateral and protrusive movements of the mandible, which were registered by direct visual inspection at a distance of 3 mm from CO, were also identified with articulation paper. Also recorded were the non-working side interferences, the occlusal scheme such as canine protection or group function, and the presence of anterior guidance and posterior contacts, during protrusion. In addition, the degree of attrition was assessed.

Obtaining

EMG

and MKG

recordings

The following tests were used for data analysis. The Mann-Whitney IJ test was used to compare the electromyographic and kinesiographic recordings and some of the clinical data between the two groups. To compare qualitative variables between the two groups, the chi-squared test was used. Fisher’s exact test was used when the numbers were small. When the effects of several variables on symptoms were being evaluated, multifactorial analysis for

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A and B session

Better

n

Symptoms

between

DENTISTRY

treatment

1

2

Unchanged

% 13

group 3

Better

Worse

n

%

n

%

n

%

12 9 13 3 5 3

42.8 32.1 46.4 10.7 17.8 10.7

15 8 6 9 10 4

53.6 28.5 21.4 32.1 35.7 14.2

1 0 0 0 1 1

3.6

3.5 3.5

binary variables was done where the symptoms were dichotomized. This was undertaken by use of the GLIM package.46 Associations were investigated between pain, headache, and Helkimo clinical dysfunction index, according to some clinical variables. This was done by one-way analysis of variance (ANOVA).

RESULTS Changes in symptoms The initial pretreatment examination showed that the real and placebo groups differed significantly from each other in relation to the prevalence of headache and to the anamnestic dysfunction index (Table I and II).45 Similarly, after the first treatment session (placebo or real), the posttreatment examination showed again that the real and placebo groups differed significantly from each other in relation to the prevalence of headache and to the anamnestic dysfunction index, which allowed for pretreatment differences. The statistical analysis showed that the prevalence of headache and of the anamnestic index was not significantly affected by treatment. Consequently, we can assume that real and mock adjustments appear to have similar effects on the overall symptoms of craniomandibular disorders, including headache. No significant changes between the placebo and real treatment group were noted considering all of the symptoms together, from A to B session (Table III). The groups had similar improvement when each symptom was considered separately. The frequency of the severity of headache for both groups, real treatment and placebo, before treatment application and 10 days after the first session of therapy, are shown in Figs. 1 and 2. Changes in the intensity of headache after first session treatment for both groups are given in Fig. 3. Twelve patients in the placebo group suffered headaches located bilaterally in the temporalis regions, three patients suffered frontal pain, and five occipital pain. Six patients had unilateral headache; in the right temporalis region for three patients and in the left for three. Only three patients had neck pain. In the real treatment group, seven patients

959

TSOLKA,

m

AND

MORRIS

10

=iti

8

x %

6

t

4

n

2

z

PREISKEL,

El

2

placebo real

0 0

1

2

3

4

5

severity

Fig. 1. Frequency of the severity of the headache in placebo and real treatment group before treatment. Scale of severity from 0 to 5.

0

1

2

3

4

5

severity

Fig. 2. Frequency of the severity of headache in placebo and real treatment group after first session of treatment. Scale of severity from 0 to 5.

had headache pain located bilaterally in the temporalis regions, 10 patients had frontal pain, two suffered occipital pain. Six patients had unilateral headache; in five patients it was in the right temporalis region and in one it was in the left, Four patients had neck pain. In addition, three patients had migraine attacks. Twelve patients from the placebo group presented with pain on the right side of the face or jaw, five with pain on the left and five with pain on both sides. In the real treatment group, seven patients had pain on the right side, five on the left, and eight on both sides. The location of the headache or pain did not appear to be affected by the kind of treatment received. Seven patients of the placebo group had clicking on the right side and eight of the real treatment group had clicking on the left side; four of the placebo group and two of the real treatment group had clicking on both sides. Differences

in psychological

status

No significant differences existed in the frequency and type of stress responses reported by the patients of both groups during the pretreatment examination. 96il

Changes

in clinical

signs

The clinical dysfunction index of Helkimo did not seem to be affected by the kind of treatment offered, placebo or real (Table IV). The total number of tender masticatory muscles decreased after the first treatment session in the placebo group from 137 to 99 and in the real treatment group from 154 to 120. Such differences between the two groups were not significant. The mean values for the border movements of the jaw for both groups before any treatment are shown in Table V. The location of premature contacts in CR, the protection scheme during lateral movements, the existence of nonworking side interferences, and the location of the contacts during protrusion before and after real and mock occlusal adjustment are shown in Table VI. Twenty-two patients (95.7 % ) of the placebo group had unilateral contacts in the CR, 12 on the left and 10 on the right side. In the real treatment group, 26 (92.8 % ) had unilateral contacts, 18 on the left and 8 on the right side. After the first-session treatment, the placebo group continued to present the same premature contacts in CR. After the initial occlusal adjustment in the real treatment group, the unilateral DECEMBER

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w ... . . . w

8

placebo real

6

worse

Fig. 3. Changes in intensity treatment session.

Table IV. Prevalence session treatment

of clinical

dysfunction

unchanged of headache

less for placebo

index by Helkimo

severe and real treatment

between

two groups

group after first

before treatment

A session*

B session*

Placebo Helkimo index

n

DiIII (severe) DiII (moderate) DiI (mild) DiO (absent) Painful muscle sites (mean) Total No. A, Before treatment. B, Ten days after first *None

of the differences

Real %

n

%

n

%

26

5

17.8

1

4.4

2

7.2

15

53.6

14

60.8

15

53.6

3

13

7

8

34.8

10

35.6

0

0

1

0

0

1

3.6

6

25 3.6

5.5

137

4.3

154

4.3

99

120

adjustment.

Assessments of clinical treatment methods for craniomandibular disturbances have been plentiful. Those employing controlled studies have been noted for their scarcity.28-34 Therefore a placebo-controlled method was DENTISTRY

n

61

session treatment, real or mock occlusal between the groups were significant

OF PROSTHETIC

%

Real

6

DISCUSSION

JOURNAL

Placebo

14

contacts in CR were eliminated in only two patients. Tu’o significant associations were found between pain and headache with most of the variables; only the number of teeth appeared to have a significant association with headache, particularly when the number of teeth was decreased (Table VII). The Helkimo anamnestic dysfunction index was correlated positively with the clinical index. Significant associations were found between the Helkimo clinical dysfunction index and age, with the clinical dysfunction index worst in the group I5 to 25 years of age. When associated with the occlusal disturbances such as non-working side interferences and group function working-side interferences during left lateral movements, significant associations were also found. The location of premature contacts in centric relation or the location of nonworking side interferences were not correlated with the location of pain.

THE

and after first

Table V. Mean values for border movements between

the two groups, Pretreatment

before

examination

Maximum opening (excluding vertical overlap) Maximum lateral right movement Maximum lateral left movement Maximum protrusive movement (excluding horizontal overlap) Vertical overlap Horizontal overlap The mean number

of present

of the jaw

any treatment.

teeth for both

groups

Placebo (mm)

Real (mm)

45

44

8.8

8.4

8.9 5.1

a.7 5.3

3.5

3.7

2.6

3.6

were 27.

used to evaluate the effects of elimination of occlusal disturbances on the signs and symptoms of craniomandibular disorders. In this report, the clinical differences between placebo and real treatment groups before and after the first session of treatment only were described. A further report will present the EMG and kinesiograph findings and how these patients previously treated with mock adjustment responded to real treatment. 961

TSOLKA,

Table

Premature

VI.

contacts

in centric

relation

contacts

in lateral

A Session* Real

Centric

analysis relation

Canine

Yes NO

Anterior Posterior

n

%

n

%

n

%

n

%

95.7 4.3

26 2

92.8 7.2

22 1

95.7 4.3

24 4

85.7 14.3

16 6

72.7 21.3

17 8

68 32

78.2

21

75

18

82.1

7

25

5

78.2 21.8

23

21.8

5

17.9

17 5

71.3 21.7

22 3

88 12

14 9

60.9 39.1

17 11

60.8 39.2

13 10

56.5 43.5

10 18

35.7 64.3

3 19

13.6 86.4

2 23

8 92

18

18.2

23

82.1

18

18.2

24

5 side interferences

21.8

5

17.9

5

21.8

4

85.7 14.3

22 0

100 0

22 3

88 12

17 6

73.9 26.1

21 7

75 25

16 7

69.6 30.4

14 14

50 50

2 20

9 91

0 25

0 100

9 14

39.1 60.9

15 13

53.6 46.4

13 10

56.5 43.5

15 13

53.6 46.4

18 4

81.8 18.2

21 4

84 16

visit.

The results

contacts

side

18 5 interferences

side scheme

Group function Right non-working

Protrusion

contacts

The results of the C session represent *No significant differences.

a subsequent

of this session are not analyzed

Our results suggest that after one treatment session, placebo therapy is almost as effective in relieving symptoms as a minor chairside occlusal adjustment (Table III). Of the placebo group, 43.5%, and of the real treatment group, 53.6% showed improvement after the first treatment session in at least one symptom, such as clicking, locking, or pain in the jaw or face. Even with each symptom considered separately, the same improvement existed in both groups (Tables I and IV). In the placebo group, 17.39% showed a decrease of the Helkimo anamnestic dysfunction index, whereas in 82.6% it remained unchanged. The corresponding percentages in the real treatment group were 21.4% and 64.3 % , respectively. Goodman et a1.40 reported that 64% (16 of 25) of their patients had total or nearly total remission of symptoms when they applied two sessions of mock adjustment for the treatment of myofascial pain dysfunction (MPD) syndrome. Unfortunately the absence of a control group and of a detailed presentation of the data makes a comparison with results of this study impossible. Observations similar to those in our study were presented in the double blind study of Forssell et al., 33 although different examiners were employed for the clinical assessment before and after therapy. In addition, their percentages for the posttreatment changes (improvement) in each symptom, between placebo and real treatment group appeared larger, because they were calculated on the basis of the total number of the referral symptoms instead of the number of patients. Furthermore, their study was not clear whether the existing

962

Real

side

NO

working

Placebo

Real

%

scheme

Yes

Canine

Placebo

n

22 1

Group function Left non-working

Left

C Session*

%

n premature

Unilateral Bilateral Right working

AND MORRIS

movements

B Session*

Placebo Occlusion

and protrusive

PREISKEL,

in this article

and are provided

for information,

significant differences in symptoms between the placebo and real treatment group during pretreatment examination affected the post-treatment results. Three patients from the placebo group and two from the real treatment group did not have headache after the first treatment session (mock or real adjustment). Changes in the intensity of headache after the first treatment session for both groups are presented in Fig. 3. Consequently it might appear that both real and mock adjustments have similar effects on headache. Improvement (reduction) of the Helkimo clinical dysfunction index was detected in 34.7 % for the placebo group (severe signs reduction [Di III] 83.3%) and in 21.4% for the real treatment (severe signs reduction 60%). The differences in the Helkimo clinical dysfunction index between the two groups were not significant. It is assumed that the clinical dysfunction index was unaffected by the kind of treatment offered to the patients. In accordance with previous reports 22, 24, there was a good correlation between the clinical and anamnestic dysfunction index. The number of painful palpated muscles sites was decreased to a similar degree in both groups (38 for placebo and 34 for real treatment) (Table IV). The results presented in this study are at variance with those of Forssell et a1.33 These investigators found a significant reduction in the signs of dysfunction in the treatment group compared with the placebo. It is not known whether their findings can be attributed to mere interobserver variability or to the fact that they applied real and placebo

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OCCLUSALADJUSTMENTTHERAPY

treatments in more sessionsin a way that exposed the benefits of real treatment. Similar conclusions were demonstrated by Kipper in a study on the effect of counseling and occlusal adjustment treatments (occlusal grinding and correction, occlusal splint, temporary partial dentures) on symptoms and signs of mandibular dysfunction, compared with a nontreatment group. The score of the Helkimo clinical dysfunction index was reduced significantly during occlusal adjustments and 67 % of the patients improved. No further effect on the symptoms was detected as had occurred during the counseling period. It should be mentioned that an experimental introduction of “balancing side” interferences in two groups of’ young healthy subjects free of CMD symptoms (double blind study),22 showed that in th.e experimental group 10 persons reported one or more symptoms and seven exhihited clinical signs whereas in the placebo group three persons reported symptoms and had clinical signs of dysfunction. According to other placebo-controlled studies assessing different kinds of therapy, the placebo effect of a splint application on the subjective symptoms of CMD (remission) was 40%,37 and the placebo effect of counseling (doctorpatient relationship) between 52 % 38and 60 % .2gWith the meprobamate drug therapy, 58% of the patients reported an improvement in their symptoms as did 31% with the placebo.36 The effect of diazepam was significantly better than that of the placebo. 3g In a facial pain study, 71% of patients were pain free in the dothiepin group at 9 weeks compared with 47% in the placebo group.42 The response of patients to real occlusal adjustment was less in the present investigation than in other studies, where approximately 50 % to 90 % of patients had good to excellent relief with conservative treatment procedures.34,47 It would he a mistake to extrapolate from the data presented in this article. The results obtained after the first treatment session do not take into account patients who had mock adjustments, but later were treated with real ones. Most important, it appears that by using conventional jaw-positioning techniques and articulating paper, the clinician was only able to remove all of the CO-CR slides and non-working interferences in approximately half of the patients in the first treatment session. These results were compared with the placebo group, not the results of the second treatment session when all the interferences were removed. Nevertheless, the clinician concluded that the interferences had been removed when the patient was dismissed at the first treatment session. It is not likely that most clinicians would have fared differently. It is possible that small movements of the teeth occurred within the loday period before the next examination. Such movements are more likely in patients who have undergone real occlusal adjustments. On the basis of these data, it should not be suggested that a patient with an obvious premature contact should be treated by counseling. Indeed, there were

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DENTISTRY

VII. Mean correlations between pain, headache, the Helkimo clinical dysfunction index, and the other variables after pretreatment examination of the 51 patients

Table

Variable

(face

Pain &jaw)

Di Helkimo clinical index

Headache

Age 15-25 26-35 36> Number of present teeth 28-32 27< Premature contacts in CR Unilateral Bilateral Right lateral movement; occlusal scheme Canine guidance Group function Left lateral movement; occlusal scheme Canine guidance Group function Right lateral movement non-working side interferences No Yes Left lateral movement non-working side interferences No Yes Protrusive contacts Anterior Posterior Anterior + posterior

0.88 0.78 0.80

2.35 1.84* 1.73

3.11 2.52 2.06

0.84 0.80

1.80 2.16

1.9 3.2

0.76 0.94

1.93 2.16

2.56 2.66

7.30 7.41

1.92 2.16

2.55 2.75

7.30 7.38

1.87 2.40*

2.52 2.90

0.85 0.80

2.0 1.9

2.1 2.8

0.69 0.86

1.5 2.1*

2.5 2.6

0.7 1.0 0.9

1.9 2.2 1.9

2.3 3.6 2.5

*Significant association, p < 0.05.

significant associations with right-sided non-working interferences and the Helkimo clinical dysfunction index. This article illustrates some of the problems of attempting a double blind clinical trial with present day ethical constraints. An undeniable and marked placebo effect has been demonstrated together with the possible multifactorial etiology of craniomandibular disorders. CONCLUSIONS This article has shown some of the difficulties involved in a clinical trial within the context of present day ethical restraints. A marked placebo effect was demonstrated, together with the difficulties of eliminating slides and nonworking interferences in one treatment session, when treatment is provided directly in the mouth. The reader is

963

TSOLKA,

cautioned against further extrapolation from the data presented. We thank Drs. J. D. Walter and J. B. Woslfel for their advice. We would also like to express our appreciation of the late Mr. J. K. Glaysher, Research Technician in Prosthetic Dentistry, United Medical and Dental Schools (UMDS).

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DR. H. W. PRIESKEL DEPARTMENT OB PROSTHETIC DENTISTRY UNITED MEDICAL AND DENTAL SCHOOLS Guys TOWER, FLOOR 20~~ LONDON SE1 SRT

ENGLAND

DECEMBER

1992

VOLUME

68

NUMBER

6

Occlusal adjustment therapy for craniomandibular disorders: a clinical assessment by a double-blind method.

Fifty-one patients with craniomandibular disorders were divided in two groups. One group underwent mock occlusal adjustment, the other was treated wit...
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