Abstract
We appreciate the team's efforts in carrying out and reporting the randomized clinical trial addressing the computer-aided designing and manufacturing (CAD/CAM) of nasoalveolar molding (NAM) appliances in infants with bilateral cleft lip and palate (BCLP). As can be inferred from the trial registry number, two publications i.e., El-Ashmawi et al., 2022 analyzing the digitized maxillary model, 1 and El-Ashmawi et al., 2022 analyzing the two-dimensional photographs 2 are the representations of different outcomes assessed from the same sample. We would like to emphasize the strength as well as concerns regarding the quality of a few reporting mentioned in the trial.
The detailed virtual modeling stated in line with Loffelbein et al., 2015 3 in the present trial is worth mentioning. Employing the ‘parametric modeling technique’ primarily to align the cleft segments and the ‘freeform modeling technique’ later to refine the preparation has been pointed out clearly. However, according to Schiebl et al. 2018 4 while designing the CAD/NAM appliance, in addition to the cleft gap closure by reintegration, ‘the growth of the upper jaw over the 4 months of NAM therapy’ has to be considered. Ritschl et al., 2016 5 reported the incorporation of a 3% growth factor per plate (Overall: 18%, 6 plates) in their technical detail. In the present article, though the limits of manipulation per plate have been stated, the data on the growth rate considered for sequential models/appliances were missing. We intend to seek the authors’ comments on that perspective.
Regarding the article cited for the sample size calculation, we noticed that the study by Liao et al., 2014 6 compared the Grayson and Figueroa techniques of NAM, not the NAM versus CAD/NAM treatment as stated in this manuscript. As mentioned by the authors, the G-power sample size calculator requires the number of tails, alpha, and power. Additionally, the main input is the ‘effect size’ that could have been computed from the mean and standard deviation of alveolar gap width changes with NAM as reported by Liao et al. However, we wish to know that missing data – i.e., ‘the effect size’ considered in this present study for their sample size calculation.
We would appreciate your further comments.
Footnotes
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.
