Background Determine the exact slot dimension of a sample of a MBT prescription stainless steel conventional brackets from different manufacturers to compare the actual values with the nominal ones declared by the manufacturers and to verify the compliance with tolerance limits given by the ISO 27020:2019. Different batches from each manufacturer were evaluated to determine whether or not they are different in size. In addition, the geometry of the slot walls was assessed. Methods 360 stainless steel preadjusted orthodontic brackets of 12 different manufacturers were assessed. All brackets had a nominal slot size of 0.022 by 0.028 inches, belonged to the right upper central incisor, and were fabricated with the metal injection molding technique (MIM). For each manufacturer, three different manufacturing batches were evaluated. Brackets were coded using a single-blind design. Results All bracket systems in the study group except one displayed a statistically significant difference with the nominal declared value, although only four of the systems did not comply with the tolerance limits established by the ISO 27020:2019. In most of the systems, the slot height was oversized when compared to the nominal one. A significant interbatch variability was found in most of the evaluated systems. Most of the brackets walls were divergent. Conclusions The dimensional accuracy of commercially available metal brackets is not guaranteed. The respect for the norm should be enforced as well as the quality controls along the manufacturing process since orthodontic brackets are a precision medical device.

The purpose of this study was to assess the accuracy and reliability of tooth width measurements and Bolton Indices delivered by the Clin-Check Pro 6.0 software (Align Technology, San José, CA, USA). Fifty-four plaster casts were selected and measured with a manual calliper by a trained and calibrated observer. The data gathered were compared with those delivered by the software on the corresponding fifty-four virtual casts. The method reliability of the software was assessed by comparing the measurements performed by the software on 201 pairs of clin-checks corresponding to two consecutive treatment phases. Accuracy and reliability were statistically assessed using a mixed model. The software tends to provide larger widths compared with the manual method. Statistically significant differences were found in 23 teeth. At a global level, the mean difference between the methods was −0.19 mm, with a Dahlberg error of 0.24 mm and an intraclass correlation coefficient of 0.98. The Bolton Indices delivered by the two methods had a moderate correlation (ICC = 0.59; 0.69). The within method reliability of the software was extremely high. Tooth width measurements delivered by the software, despite the positive bias, can be considered accurate and clinically acceptable for all teeth except molars. The Bolton Indices made available by the software are not accurate and clinically acceptable, especially in the case of mandibular excess.

Background: The precision of bracket manufacturing is fundamental to ensure the correct expression of the inbuilt information. The objective of this study was to determine the actual tip and torque values of a pool of stainless steel brackets, pre-adjusted according to the MBT prescription values, and to compare these actual values with those stated by the manufacturers in order to test their compliance with the tolerance limits reported in the ISO 27020:2019 Methods: A sample of 360 stainless steel brackets, from 12 different providers, were evaluated. All brackets had a nominal slot size of 0.022 in., belonged to the upper right central incisor, and were manufactured with the metal injection molding technique (MIM). For each provider, three different batches of the same bracket series were tested. A single-blind design was used for bracket coding. Results: Only five systems displayed torque mean values that matched the declared values (p > 0.05). Only one system did not respect the tolerance limits established in the ISO 27020:2019 norm. The tip values were different from those declared in seven of the assessed systems; however, none exceeded the tolerance limits. The inter-batch variability in most cases was not statistically significant. Conclusions: In most of the assessed systems, there can be a difference between the actual and the declared torque values, while tip information is usually accurately incorporated into the bracket slot. Lack of precision in the manufacturing process can reduce the efficacy of the appliance and force the clinician to compensate for dimensional inaccuracy through wire bending.