BACKGROUND: Cleft lip and/or palate (CL/CP) are common congenital anomalies with multifactorial origins, potentially influenced by environmental factors, including multi-trace metal exposure. Primary teeth, which form in utero, offer a unique biomatrix for assessing early-life metal exposure, yet remain underexplored in CL/CP research. OBJECTIVE: This case-control study aimed to investigate the association between multi-trace metal exposure and CL/CP occurrence by analyzing primary teeth using Inductively Coupled Plasma Mass Spectrometry (ICP-MS). METHODS: Ethical clearance was obtained for this study, which included 30 children aged 4-12 years. Non-carious central and lateral incisors were analyzed for trace metals using ICP-MS. Demographic, socioeconomic, and nutritional data were collected via a structured proforma and environmental risk factor questionnaire. RESULTS: A comprehensive analysis of 24 trace metals in primary teeth of CL/CP and control groups found no significant associations with 25Mg, 52Cr, 43Ca, and 56Fe, with odds ratios near 1. Lower 113 Cd concentrations were linked to CL/CP. However, the small sample size (n = 15 per group) limits conclusions on the relationship between cadmium levels and CL/CP. Maternal nutritional deficiencies (p = 0.031) and lower annual income (p = 0.001) were significantly associated with increased CL/CP prevalence, suggesting socioeconomic and dietary influences. CONCLUSION: Exposure to 25Mg, 52Cr, 43Ca, and 56Fe showed no significant association with CL/CP risk, while lower 113 Cd levels suggested a potential link, though the small sample size limits interpretations. Further research is needed to elucidate the link between metal exposure and developmental anomalies, and to address cadmium's environmental and dietary sources to reduce CL/CP risk.