Evaluating the Effectiveness of 3D Directly Printed Shape Memory Aligners in the Management of Anterior Open Bite

3.0 Material and methods 3.1 Ethical approval Ethical clearance will be obtained from the Medical Ethics Committee, Faculty of Medicine, University of Kufa, Iraq (MEC-163). This randomised clinical trial will be registered and reported at clinicaltrials.gov, among Class I molars and skeletal relationships with anterior dental open bite Iraqi patients.

3.2 Sample size calculation: Sample size calculations were performed. In each group, a sample size will be calculated by G-power (version 3.1), at a power of 80% and a 0.05 level of significance, which enabled the detection of significance between the three treatment groups in overbite changes of 1.5 mm with a standard deviation of 1.5. The final anterior open bite sample consisted of 15 patients for each group. To account for a potential 10% dropout rate, two individuals will be added to each group, resulting in a final sample size of 51 individuals-17 per group, according to a previous study done by Serdar et al. (52).

3.3 Participants, eligibility criteria, and settings: Patients will be recruited from the Department of P.O.P., University of Kufa, Azadi Dental Centre, and a private dental clinic located in Iraq. The treatment will be done by a specialist orthodontist. Patients will be recruited at the time of their consultation if they meet the study criteria: Table (3.1).

Table 3.1: Study criteria.

The inclusion criteria: The exclusion criteria: