Kurzfassung

This study is comparing a two-week aligner stage treatment to a one-week aligner stage treatment over a period of maximum six months by quantifying the performance of the treatment with the digital PAR score. Participants will be randomly assigned to either Group A (two-week schedule) or Group B (one-week schedule), all stratified by the pre-treatment scores and gender. No blinding is possible. Treatment is planned and defined by a trained dental technician together with the prescribing...This study is comparing a two-week aligner stage treatment to a one-week aligner stage treatment over a period of maximum six months by quantifying the performance of the treatment with the digital PAR score. Participants will be randomly assigned to either Group A (two-week schedule) or Group B (one-week schedule), all stratified by the pre-treatment scores and gender. No blinding is possible. Treatment is planned and defined by a trained dental technician together with the prescribing doctor (investigator). All participants will get their set of aligners according their allocated treatment plan. Therefore, number of aligners, as well as the procedure of the teeth movement is individually adjusted and differs from patient to patient. The following three follow-up visits are planned:
- 4 week
- 12 week
- 6 months
The digital Pre- and post-PAR score will be compared for each participant and group. The score will be used to confirm performance and safety of both treatment strategies with the 3-layser aligners. The perceived treatment outcomes will be correlated to the dentition status and by recording patient reported outcome measures (PROMs), the treatment quality will be confirmed from the patient perspective. The digital PAR will be assessed by an independent assessor. The study will show safety by comparing all AEs for both treatment schedules and by assessing the following secondary outcome parameters:
- External Apical Root Resorption (EARR)
- Gingival recession
- Loss of periodontal support
The sample size calculation is based on the publication of Graf et al (2021), assuming a mean change in PAR Index for the one week aligner group of 17.54 with a SD of 6.83 and considering a tolerance range of 3.9 points for the test. Showing non-inferiority for a power of 80% for a test of clinical equivalence a sample size of 35 individuals per group would be needed. Assuming a drop-out rate of 20%, this study aims to recruit 84 patients.Given that the data is normally distributed, primary Outcome will be statistically assessed using a one-tailed T-Test, with a significance level set at α=0.05. Otherwise, a non-parametric test will be applied.Secondary Outcomes will be quantitatively described by means and standard deviations. Differences between the two groups will be tested using Wilcoxon-Rank-Sum tests with a significance level set at α=0.05.




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