Cleft Care India Study: A National Audit on Patients with Non-Syndromic Unilateral Cleft Lip and Palate Patients. Part 1: Background, Skeletal, Dental Arch, and Nasolabial Outcomes

Background: India has one of the world's largest burdens of cleft lip and palate (CLP), yet lacks a national outcomes registry or standardized system for cleft care evaluation. The Cleft Care India Study is a multicentric national initiative to assess current treatment outcomes for patients with non-syndromic unilateral CLP for 5-, 12-, and 20-year-old age groups. Methods: Fourteen cleft care centers across India participated in this cross-sectional study. Standardized protocols for collecting data were formulated with input from the Study Steering Committee, validated through pilot testing, and employed for data collection. Data collected included intra-oral and extraoral photographs, study models, radiographs, surgical information, oral health assessments, speech recordings, hearing evaluations, psychosocial measures, and the intelligibility in context scale questionnaire. In this paper, we present the dentofacial outcomes. Skeletal relationships were analyzed using ANB, SNA, and SNB angles derived from cephalometric radiographs; dental arch relationships were evaluated using the 5-year or modified GOSLON indices; and nasolabial esthetics were assessed with the Asher-McDade index. Results: Data from 294 non-syndromic unilateral cleft lip and palate (UCLP) patients aged 5 (n = 72), 12 (n = 155), and 20 years (n = 67) were analyzed. Reliability testing showed strong intra and inter-rater agreement for all indices and cephalometric data (class correlation coefficient > 0.9). Nearly half of 12 year olds (46.5%) and more than half of 20 year olds (58.7%) demonstrated a Class III skeletal relationship (ANB < 0). Poor to very poor dental arch relationships (score > 3) were observed in 45%, 48%, and 43% of the 5-, 12-, and 20-year groups, respectively. Nasolabial esthetic outcomes were rated poor to very poor in 24.3% of 5 year olds, 25% of 12 year olds, and 55.4% of 20 year olds. Conclusion: This multicentric cleft outcomes audit in India demonstrated suboptimal skeletal, dental, and nasolabial outcomes when benchmarked against international standards. These findings highlight an urgent need for the centralization of cleft services, implementation of systematic national outcome monitoring, and adoption of standardized multidisciplinary care pathways to improve the quality and consistency of cleft management across India.