Journal of Clinical Medicine Article Reliability and Reproducibility of Landmark Identification in Unilateral Cleft Lip and Palate Patients: Digital Lateral Vis-A-Vis CBCT-Derived 3D Cephalograms Anuraj Singh Kochhar 1,* , Ludovica Nucci 2, Maninder Singh Sidhu 3, Mona Prabhakar 3 , Vincenzo Grassia 2 , Letizia Perillo 2, Gulsheen Kaur Kochhar 4, Ritasha Bhasin 5, Himanshu Dadlani 6 and Fabrizia d’Apuzzo 2 1 Former Consultant Orthodontist Max Hospital Gurgaon, Haryana 122001, India 2 Multidisciplinary Department of Medical-Surgical and Dental Specialties, University of Campania Luigi Vanvitelli, 80138 Naples, Italy; [email protected] (L.N.); [email protected] (V.G.); [email protected] (L.P.); [email protected] (F.d.) 3 Department of Orthodontics & Dean, Research & Development Faculty of Dental Sciences, SGT University Gurugram, Haryana 122505, India; [email protected] (M.S.S.); [email protected] (M.P.) 4 Department of Pediatric & Preventive Dentistry, National Dental College & Hospital, Punjab 140507, India; [email protected] 5 Faculty of Dentistry, University of Toronto, Toronto, ON M5G1G6, Canada; [email protected] 6 Senior Consultant Department of Dentistry (Periodontology), Max Hospital, Gurgaon, Haryana 122001, India; [email protected] * Correspondence: [email protected] Citation: Kochhar, A.S.; Nucci, L.; Sidhu, M.S.; Prabhakar, M.; Grassia, Abstract: Background: The aim of the retrospective observational study was to compare the precision V.; Perillo, L.; Kochhar, G.K.; Bhasin, of landmark identification and its reproducibility using cone beam computed tomography-derived R.; Dadlani, H.; d’Apuzzo, F. 3D cephalograms and digital lateral cephalograms in unilateral cleft lip and palate patients. Methods: Reliability and Reproducibility of Cephalograms of thirty-one (31) North Indian children (18 boys and 13 girls) with a unilateral cleft Landmark Identification in Unilateral lip and palate, who were recommended for orthodontic treatment, were selected. After a thorough Cleft Lip and Palate Patients: Digital analysis of peer-reviewed articles, 20 difficult-to-trace landmarks were selected, and their reliability Lateral Vis-A-Vis CBCT-Derived 3D and reproducibility were studied. These were subjected to landmark identification to evaluate Cephalograms. J. Clin. Med. 2021, 10, interobserver variability; the coordinates for each point were traced separately by three different 535. https://doi.org/10.3390/ orthodontists (OBA, OBB, OBC). Statistical analysis was performed using descriptive and inferential jcm10030535 statistics with paired t-tests to compare the differences measured by the two methods. Real-scale data are presented in mean ± SD. A p-value less than 0.05 was considered as significant at a 95% confidence Academic Editors: Emmanuel Andrès and Gianrico Spagnuolo level. Results: When comparing, the plotting of points posterior nasal spine (PNS) (p < 0.05), anterior Received: 3 January 2021 nasal spine (ANS) (p < 0.01), upper 1 root tip (p < 0.05), lower 1 root tip (p < 0.05), malare (p < 0.05), Accepted: 26 January 2021 pyriforme (p < 0.05), porion (p < 0.01), and basion (p < 0.05) was statistically significant. Conclusion: Published: 2 February 2021 In patients with a cleft lip and palate, the interobserver identification of cephalometric landmarks was significantly more precise and reproducible with cone beam computed tomography -derived Publisher’s Note: MDPI stays neutral cephalograms vis-a-vis digital lateral cephalograms. with regard to jurisdictional claims in published maps and institutional affil- Keywords: cleft; accuracy; unilateral cleft lip and palate; CBCT; interobserver; cephalogram iations. 1. Introduction Copyright: © 2021 by the authors. Since its advent in 1931 [1], conventional cephalometry has been one of the essential Licensee MDPI, Basel, Switzerland. diagnostic tools for analyzing orthodontic problems, maxillofacial deformities, evaluating This article is an open access article growth, and planning treatment [2]. However, difficulty in locating imperceivable anatomic distributed under the terms and landmarks and superimposition of craniofacial structures, owing to the two-dimensional conditions of the Creative Commons (2D) representation of three-dimensional (3D) anatomy, are amongst the limitations of tradi- Attribution (CC BY) license (https:// tional cephalometrics [3–5]. Young cleft lip and palate (CLP) patients usually present with a creativecommons.org/licenses/by/ flattened cranial base, midface deficiency with a retruded maxilla and elongated mandible, 4.0/). J. Clin. Med. 2021, 10, 535. https://doi.org/10.3390/jcm10030535 https://www.mdpi.com/journal/jcm J. Clin. Med. 2021, 10, 535 2 of 11 anterior and/or posterior crossbites, and an increased vertical dimension, thereby making the recognition of cephalometric landmarks even more arduous [4,5]. The localization of landmarks like point A, the anterior nasal spine (ANS), and the posterior nasal spine (PNS) is challenging due to the decreased opacity resulting from the cleft [6]. The remodeling of the tooth germs in young patients, especially in the anterior contour of the maxilla, can be a possible cause for the same according to Hotz and Gnoinski [7]. According to published data, it is difficult to interpret radiographs in patients with CLP before the exfoliation of the incisors for the abovementioned problems, thus questioning the reliability of cephalometric measurements for the same [8,9]. In the present times, when imaging has been revolutionized, cone beam computed tomography (CBCT) aids in avoiding the anatomic superimpositions and problems caused by magnification, thereby permitting the evaluation of the craniofacial structures from unobstructed perspectives with minimal distortion. Three-dimensional (3D) images from CBCT scans can be rotated easily by changing the rotational axis, as convenient to the observer [2,10]. Specifically, regarding cleft patients, previous studies have advocated CBCT as an exceptional tool for the determination of bone volume [11–14], bone and root morphology, the assessment of tooth development in the vicinity of the cleft area [15–18], and soft tissue depth. In orthodontics, cephalograms are repeatedly traced and reviewed. For impeccable treatment planning, the reliability and reproducibility of these anatomical landmarks are imperative, especially in patients with CLP where the identification of landmarks is highly challenging and, therefore, difficult to perceive and reproduce. Although the synchronal literature in the past several years has emphasized the pivotal role of CBCT to determine the reliability [19–27] of anatomic landmarks, there is a paucity of studies for the same, along with their reproducibility in CLP patients versus cephalometrics where the localization of anatomy is challenging. A lot of studies have emphasized the difficulty in the plotting of bilateral land- marks [2,19–21], but none have been done in a compromised craniofacial morphology. To know the actual degree of midfacial retrusion along with the compromised craniofacial morphology that is usually present in cleft patients, the accuracy of landmark identification plays an important role [6,26]. Therefore, the present study was conducted to compare the reliability and repro- ducibility of landmark identification using two systems: CBCT-derived 3D cephalograms vis-a-vis digital lateral cephalograms in unilateral cleft lip and palate (UCLP) patients. 2. Materials and Methods 2.1. Ethical Approval Approval for the retrospective observational study was obtained from Shree Guru Gobind Singh Tricentenary (SGT) Dental College, Hospital, and Research Institute, Bud- hera, Gurgaon, India (SGTDC/PPL/Com./E.C./14 August 2010) (institutional ethical committee). All records acquired from the Department of Orthodontics and Dentofacial Orthopedics from March 2011 to May 2013 were used only for research purposes, for which prior informed consent had been taken. 2.2. Methodology Examination of records of 54 North Indian children (aged 10–14 years) with a repaired CL ± P anomaly was done. For the sample size estimation in the present study, power analysis at 80% power, a 0.5 alpha level, and an effect size of 0.8 suggested that a minimum of 21 patients were required. Records of thirty-one children (Table1) who had primary CLP repair performed before 18 months of age, with no secondary alveolar bone grafts and no prior orthodontic/orthopedic appliance intervention (but recommended for comprehensive orthodontic treatment), were selected and designated as samples. Patients’ records not fulfilling any of the above inclusion criteria or with any syndrome or mental retardation as documented in the medical history were excluded. J. Clin. Med. 2021, 10, 535 3 of 11 Table 1. Sample Characteristics. Boys (n = 18) Girls (n = 13) Total Sample (n = 31) Mean SD Range Mean SD Range Mean SD Range Age (yrs.) 12.035 0.690 10–14 12.13 0.724 10–14 12.09 0.698 10–14 Cephalograms had been acquired using PlanmecaPromax (Planmeca Co, Helsinki, Finland) in a natural head position, stabilized by ear rods. The scans were obtained at 66 kvp and 5 mA. The JPG images were obtained and transferred to the Nemoceph NX software (Visiodent, Saint-Denis, France) for calibration and analysis, which was done with a scale present on the X-ray as a 10 mm measurement marked on the cephalogram. CBCT scans had been acquired using an i-CAT next-generation machine (Imaging Sciences International,