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
Year: 2025
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
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.
Authors: Karthika Krishnakumar, Ritesh Kalaskar
Institution: Govt. Dental College & Hospital
Language: English
Subfield: Genetics
Domain: Life Sciences
Open Access status: diamond
OpenAlex ID: W4411784398