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Alginate impressions, stone models, bite registration and face-bow ... After that models and wax-up were scanned (Scanner S600 Arti, ZirkonZhan) to digital.
Comparison between conventional and CAD/CAM occlusal appliances in the management of temporomandibular disorders and/or bruxism – a randomized controlled trial. Dias R, Fonseca J, Alves C, Messias A, Guerra F Faculty of Medicine, University of Coimbra, PORTUGAL

Despite the shortage of scientific evidence, occlusal appliances remain one important tool in the multidisciplinary management of patients with bruxism and/or temporomandibular disorders (TMD). Recently, it has been suggested that CAD/CAM systems may offer advantages producing occlusal appliances and overcome some limitations attributed to conventional methods. This clinical randomized controlled trial compared the effectiveness between CAD/CAM and conventional occlusal appliances.

CLINICAL PROTOCOL

A total of 24 patients were selected in the Faculty of Medicine, University of Coimbra - Portugal. Clinical exam, RDC-TMD (Portuguese version) and Maciel questionnaire were used at baseline, 90 and 180 days. A questionnaire was developed by our research group to collect objective and subjective information from patients about appliances and therapy evolution (IMMPACT orientations). Alginate impressions, stone models, bite registration and face-bow transference were done. Models were first mounted in mechanical articulator. Over them, the technician did a manual wax-up of a mandibular stabilization oclusal appliance. After that models and wax-up were scanned (Scanner S600 Arti, ZirkonZhan) to digital articulator and designed the virtual prototype of the appliance in CAD software (Modellier, ZirkonZhan). After the definition of the final morphology, retention, thickness and occlusion scheme in virtual tool, all body of the appliance was milled in a rigid transparent acrylic using a computerized milling unit (M3, ZirkonZhan). Other appliance was obtained of the wax-up by conventional lost wax technique and at the end both were adjusted and polished manually over mechanical articulator. Each patient were constructed the two splints and at baseline both were inserted, evaluated, compared and adjusted by a experimented clinician. In this RCT protocol the randomization was made only after baseline adjustments and evaluation. According the result the patient was integrated in CAD/CAM or conventional study group. The correspondent appliance was delivered. Controls were performed at 30, 90 and 180 days.

LABORATORIAL PROTOCOL

Figure 2 – Muscle palpation during clinical evaluation. Some points Figure 1a, 1b, 1c – Clinical Case - Initial Situation checked with a – Patient with TMD after orthodontic treatment (disc calibrated device displacement with reduction, myalgia with (PALPETER) occasionally mouth opening limitation, arthralgia).

Figure 6a, 6b - Conventional and CAD/CAM appliances to same patient and ready to clinical evaluation.

Figure 4 – Intermaxilar registration at vertical and horizontal rehabilitation position desired (DELAR registration wax). Figure 3a, 3b – Face-bow transference with ARTEX device.

Figure 5a, 5b, 5c – CAD/CAM appliance in mouth (frontal and lateral views)

Figure 7 – Code Identification of each appliance in study.

Figure 8a, 8b, 8c, 8d – Intraoral occlusal evaluation of conventional appliance (MIP, protrusion, lateral excursions). 8e – Occlusal marks obtained with articulating foil (Hanel 24µm).

Figure 12a, 12b, 12c, 12d – Manual wax modeling over ARTEX articulator. Figure 14a, 14b, 14c, 14d – Check occlusion over articulator previously to clinical evaluation (Conventional and CAD/CAM appliance, respectively).

Figure 9a, 9b, 9c – Alginate impressions. Work models - stone type III.

Figure 10a, 10b – Transference of face-bow position and mounting maxillary model (articulator Artex CT).

Figure 11 – Work models mounted in mechanical articulator (ARTEX . Figure 13a, 13b, 13c, 13d – Model scan, virtual design, PMMA resin block virtual visualization and appliance after milling process.

Figure 15a – Recording thickness. 15b e 15c - Evaluation of occlusion by computerized (T-Scan) and conventional method, respectively.

SAMPLE CHARACTERIZATION AND RANDOMIZATION

BASELINE

PROGRESSION OVER TIME



Group I

Retention



Conventional vs. CAD/CAM

Mild

Positive ranks

Moderat e High

Negative ranks

46

Equal ranks

36

Conventional Yes

Adequate limits and shape

41

Yes Yes

Yes

No No

No

No

Conventional Yes

standard deviation. Compared with t-test for paired samples. 95% CI - confidence interval of 95% for the difference).

Uniform aspect and absence of distortions

Yes No

No

Yes

Correct posterior surface

Yes

Yes

No

No

Yes

Yes

Stability

Yes

Yes

No

No

No

Conventional Yes

Adjustments need to insertion

Yes

Yes

No

No

No

Anterior disocclusion guidance

Yes No



Unilateral disc

Unilateral disc displacement with reduc2on

without reduc2on



Without Classifica2on - Bilateral

Bilateral Arthralgia

Unilateral Arthralgia

Without Classifica2on

Unilateral Arthralgia

Bilateral Arthralgia

Without Classifica2on



Nor mal

Normal

Moderate

Normal

Moderate

Passivity

Yes

Yes

No

No

Mod

Severe

Mild

Moderate

Moderate

Mild

Sev

Sev

Mild

Sev

Mod

Mild

Mod

Sev

Retention R

Mild

Positive ranks

Moderate

Negative ranks

High

Equal ranks

Comfort referred by patient

Yes

Yes

No

No

Surface texture

Smooth

Yes

Roughness

No

R

Adverse reaction R

Yes

Yes

No

No



Gender























2 11 2 2 11 1 1 1 11 1 1 1 1 11 11 1 1 1 11 11 11 1 1 1 1 2

CONV.

CAD

CONVen7onal CAD

CONV.

CAD

CONV.

CAD/CAM

CONV.

Difference (95% CI)

Figure 17 – General sample characterization by RDC/TMD axis I and II classification, bruxism grade, gender and randomization result (respective study group).

Anterior Posterior Right Posterior left

Yes

No

No

CAD/CAM – incapacity rate

No

Grinding/Clench During night

Yes

Conventional – incapacity rate

No

No Smooth

Graphic 2 - Pain intensity and incapacity rate for both groups.

Roughness

Figure 12a, 12b, 12c – Clinical Case II - CAD/CAM appliance in position (frontal and lateral views). Table 7 - Evolution of the signs and symptoms reported by the Tinnitus

Yes No

Yes No

CAD/CAM– Total

patient according to the axis I –RDC-TMD (p value given by Friedman test for overall comparison of paired samples).

Conventional - Total CAD/CAM–Posterior left area Conventional– Posterior left area CAD/CAM– Anterior area Conventional– Anterior area CAD/CAM– Posterior right area Conventional– Posterior right area

No

No

Depression

GLOBAL COMPARISON RESULTS

Table 4 - Comparison of time needed to occlusal adjustments between appliances (Values in millimeters. Mean ± standard deviation.

Specific Ques+onnaire

difference).

Subjec'vely parameters related to appliance wear

No

Morphology and adapta'on aspects

Occlusal adjustments

Specific symptoms

RDC/TMD

Compared with t-test for paired samples. 95% CI - confidence interval of 95% for the

Axis I Muscule and/or ar'cular pain places

Ar'cular sounds

Specific symptoms without pain

Axis II

Mandibular range of mo'on

Signs and symptoms refered

Pain and disability

Depression

Table 2 - Comparison between objective and subjective parameters evaluated during intraoral insertion (Conventional vs CAD based on the Wilcoxon test for paired samples. positive Ranks mean higher retention for conventional gutters, negative ranks mean higher retention for leaks CAD and draws mean equal retention).

Graphic 3 - Number of occlusal adjustments necessary to equilibrate the appliances over time.

Bruxism Scale Soma'za'on

Table 8 - Evolution of the parameters evaluated by the axis II of the RDC-TMD over 180 days for both study groups (Mean ± standard deviation. ANOVA for repeated measures to evaluate the progress of each group over time (F test)). Occlusal contact classification

Anterior

Posterior

TOTAL

SS

No

Figure 16 - CAD/CAM appliance before and after occlusal adjustments, respectively.

CS WCS

Appliance contribution

Yes No

Mean

Mean

Difference

Role of appliance in clinical evolution Worst

WSS

x

x



CAD

R

Yes

Yes

Time needed to adjustments

Conv.

Facility to insert and remove

Conventional– intensity of pain

No

Yes

Morning facial soreness

Occlusal appliance

Yes

Grinding/Clench During day

Uncomfortable Bite position

Conventional Yes

CAD/CAM – intensity of pain

Crepitation Joint Sound

No

Conventional Yes

Graphic 1 - Comparative aspect of the variation of open/close range of motion over time for both study groups.

Conventional

Conventional Yes

Total

Click Joint Sound

Conventional Yes

CAD/CAM – opening without pain

Yes

Conventional

Conventional vs. CAD/CAM

Left

Mod

No

No

No

Conventional – opening without pain

between groups by ANOVA repeated measures with a fixed factor).

positive Ranks mean higher retention for conventional appliances, negative ranks mean higher retention for leaks CAD and draws mean equal retention).

A r e a

Right

Conventional

Table 3 - Extra oral comparison of morphologic and adaptation parameters (Conventional vs CAD based on the Wilcoxon test for paired samples.

Conventional

Articular pain sites

CAD/CAM – passive opening

Conventional

Table 6 - Characterization of painful muscle and joint locations in different periods of evaluation by appliances (Longitudinal comparison and

Normal

Mod

Conventional – passive opening

Total

Bilateral Arthralgia

CAD/CAM – active opening

Left

displacement

Conventional Yes

Muscular pain sites

No

Conventional

Conventional





Conventional Yes

Bilateral disc displacement with reduc2on

Without Classifica2on - Bilateral

Group II

Group III

No

Conventional – active opening

Right



Bruxism Scale

Table 1 – Thickness evaluation (Values in millimeters. Mean ±

Without Classifica2on

Myofascial pain

Depression

Conventional

Maciel

Difference (95% CI)

Axis II

Conventional

RDC/TD Axis I

Surface

Diagnos7c

AREA



x



x



x



x

√ √

x



x

x



x

X



Table 9 - Frequency of occlusal contacts in convention appliances. Occlusal contact classification



x

x

Table 5 – Global comparison results (SS – Statistical significance; WSS – Without statistical significance; CS – Clinical significance; WCS – Without clinical significance).

This comparative study showed similar effectiveness between CAD/CAM and conventional appliances. However, CAD/CAM presented some advantages and better clinical outcome for the patients. CAD/CAM is a potentially useful method to produce occlusal appliances.

Clinical Evolution Perspective

Anterior

Posterior

TOTAL

x

Similar Better Significant better Asymptomatic

Appliance wear in future

Always Sometimes Acute pain situation Never

Table 11 - Results of the questionnaire given to the patients to 180d control. Evaluating subjective parameters reported by the patient and prospects face to treatment (Mean ± SD scales for pain and Table 10 - Frequency of occlusal contacts in CAD/CAM appliances.

comparing CAD / CAM vs. Conventional with Student's t test. 95% CI confidence interval of 95% for the difference between means. adhesion test to chi-square for nominal or ordinal responses).

1. 

Truelove, E., et al., The efficacy of traditional, low-cost and nonappliance therapies for temporomandibular disorder: a randomized controlled trial. J Am Dent Assoc, 2006. 137(8): p. 1099-107; quiz 1169.

2. 

Lavigne, G.J., et al., Bruxism physiology and pathology: an overview for clinicians. J Oral Rehabil, 2008. 35(7): p. 476-494.

3. 

Manfredini, D., et al., Prevalence of bruxism in patients with different research diagnostic criteria for temporomandibular disorders (RDC/TMD) diagnoses. Cranio-the Journal of Craniomandibular Practice, 2003. 21(4): p. 279-285.

4.  5.  6. 

Greven, M., TMD, bruxism, and occlusion. American Journal of Orthodontics and Dentofacial Orthopedics, 2011. 139(4): p. 424-424 Alencar, F., Jr. and A. Becker, Evaluation of different occlusal appliances and counselling in the management of myofascial pain dysfunction. J Oral Rehabil, 2009. 36(2): p. 79-85. Fricton, J., Current evidence providing clarity in management of temporomandibular disorders: summary of a systematic review of randomized clinical trials for intra-oral appliances and occlusal therapies. J Evid Based Dent Pract, 2006. 6(1): p. 48-52.

7. 

Wassell, R.W., N. Adams, and P.J. Kelly, Treatment of temporomandibular disorders by stabilising appliances in general dental practice: results after initial treatment. Br Dent J, 2004. 197(1): p. 35-41; discussion 31; quiz 50-1.

8.  9. 

Dao, T.T., et al., The efficacy of oral appliances in the treatment of myofascial pain of the jaw muscles: a controlled clinical trial. Pain, 1994. 56(1): p. 85-94 Ekberg, E.C., D. Vallon, and M. Nilner, Occlusal appliance therapy in patients with temporomandibular disorders. A double-blind controlled study in a short-term perspective. Acta Odontol Scand, 1998. 56(2): p. 122-8.