Materials and Methods

This study was carried out in Portugal in the city of Viana do Castelo during
orthodontic consultations and by the same operator between 12/03/2017 and 30/06/2017.

The sample was 200 male patients with Class II 2 aged 12-16 years old in orthodontic
treatment with brackets requiring TIM class II. After this, patients were divided into these two
groups with randomly:

-Control group: 100 patients doesn 't using intermaxillar elastics

- Treatment group: 100 patients with intermaxillar elastics of Class II

It was verified at the beginning of the study that all patients did not present pathology
without problems of TMJ and we applied intermaxillar elastics (Wallaby – Americam
Orthodontics ®) on the exposed group for 3 months.

After 3 months, clinical examinations on the exposed group were performed on each
patient with a clinical interview and physical examination to detect TMD. For that, we used
the criteria published by the International RCD / TMD Consortium Network and orofacial
pain but only three parameters have been evaluated (muscle pain, muscular pain and
decreased mouth opening).

Statistic Test

To verify the existence of undesirable effects (TMD) caused by the wearing of

intermaxillar elastics a comparison test of proportions was carried out.

-Hypothesis:

H0 (null hypothesis): the frequencies of TMD are equal in the 2 groups (Treatment
(T) and control group (C)):

pT = pC

H1 (alternative hypothesis): the frequency of TMD in the exposed group is significantly

different from that of the control group: pT ≠ pC

-Definition of the statistical test parameter:

It is to highlight that :

- pT and 𝒑𝑪 are assumed to be independent: the occurrence of TMD in one group does not
affect the likelihood of occurrence of TMD in the second group.

-Under the null hypothesis 𝑯𝟎, 𝜋̂ is a good estimate of the average rate of TMD patients.

-Under the null hypothesis 𝑯𝟎, Z is approximately distributed according to the law Normal N
(0,1).

Under the null hypothesis 𝑯𝟎, the validity condition of the test relative to the size of the
samples is verified:

- Definition of the threshold of significance

The adopted threshold is the conventional threshold: α = 0.05.

Thus, the confidence interval obtained from the distribution table of the Normal distribution is
as follows:
𝐼𝑃0.95 = [−1.96 ; 1.96]

-Establishment of the decision procedure

If 𝒁 ∈ 𝑰𝑷𝟎.𝟗𝟓 , hypothesis 𝑯𝟎 is not rejected: we do not conclude.

If 𝒁 ∈ 𝑰𝑷𝟎.𝟗𝟓, the hypothesis 𝑯𝟎 is rejected: at the risk of error of 5%, the frequencies of TMD
are significantly different between the patients wearing intermaxillary elastics and those not
wearing them.

- Implementation of the statistical test

𝑝𝐸 − 𝑝𝑇 0.27 − 0
𝑍 = = = 5.56
𝜋̂(1 − 𝜋̂) 𝜋̂(1 − 𝜋̂)
√ − √0.13(1 − 0.13) − 0.13(1 − 0.13)
𝑛𝐸 𝑛𝑇 92 100

𝑍 ∉ [−𝟏. 𝟗𝟔 ; 𝟏. 𝟗𝟔] Rejection of hypothesis 𝐇𝟎