Comparative evaluation of digital and tray impression technique as a method of recording anatomical details of cleft lip and palate in neonates - A randomized controlled clinical trial

• Published in: Journal of the Indian Society of Pedodontics and Preventive Dentistry Vol. 43; no. 2; pp. 244 - 251
• Main Authors: Krishnakumar, Karthika, Kalaskar, Ritesh
• Format: Journal Article
• Language: English
• Published: India Wolters Kluwer - Medknow 01.04.2025; Medknow Publications and Media Pvt. Ltd; Medknow Publications & Media Pvt. Ltd; Wolters Kluwer Medknow Publications
• Edition: 2
• Subjects: Accuracy; Cleft lip; Cleft Lip - pathology; cleft lip and palate; Cleft lip/palate; Cleft Palate - pathology; Clinical trials; Comparative analysis; Dental Impression Technique; digital impression technique; Feeding; Female; Humans; Infant, Newborn; Infants (Newborn); Male; Medical research; Medicine, Experimental; Methods; Neonates; Original Article; randomized controlled trial; Single-Blind Method; Statistical analysis; digital impression technique; Cleft lip and palate; randomized controlled trial
• ISSN: 0970-4388; 1998-3905
• DOI: 10.4103/jisppd.jisppd_533_24

ABSTRACT Background: Cleft lip and palate (CLP), affecting 1 in 700-1000 live births, cause feeding difficulties in neonates due to oronasal communication, requiring feeding plates. Traditional impression methods risk material aspiration and distortion. Aim: The study aimed to assess the efficacy of digital impressions for recording CLP anatomical details in neonates. Setting and Design: Conducted as a single-center, open, parallel-arm, single-blinded randomized controlled clinical trial over 18 months, the study involved healthy, nonsyndromic neonates aged 1-15 days with Veau's class III CLP. Materials and Methods: A total of 32 neonates were randomly allocated to either the tray impression group or the DIT group. The accuracy of the impression and adaptation of the feeding plate is evaluated. Statistical Analysis: The independent t-test was used to compare the accuracy of anatomical details recorded by digital and tray impression techniques in CLP neonates. Intragroup and intergroup comparisons of sulcus, ridge, and palate deviation on the right and left sides were analyzed using an independent t-test based on software superimposition of the feeding plate and maxillary cleft arch. Results: The anteroposterior length of the cleft and sulcus depth middle region of CLP exhibited significant differences (P = 0.001 and P = 0.032, respectively) between the groups. Furthermore, Group 1 displayed notably higher values in the sulcus, ridge, and palate point deviation measurements during software superimposition. Conclusion: Surface detailing, impression accuracy, and feeding plate adaption were all shown to be outstanding with DIT, in addition to its benefits as the safest and simplest impression technique.