Cleft lip/palate

Cleft lip with cleft palate is a common congenital craniofacial malformation in which there is an opening (cleft) in the upper lip that extends into the palate (roof of the mouth). This condition results from incomplete fusion of the facial and palatal structures during early embryonic development, typically between the 4th and 12th weeks of gestation. It may occur unilaterally (on one side) or bilaterally (on both sides), and the severity can range from a small notch in the lip with a minor palatal cleft to a complete separation extending through the lip, alveolar ridge (gum), hard palate, and soft palate. The condition is present at birth and is typically identified during prenatal ultrasound or at delivery. Cleft lip with cleft palate affects multiple body systems and functions. Feeding difficulties are among the earliest challenges, as the opening between the oral and nasal cavities impairs the infant's ability to create adequate suction for breastfeeding or bottle-feeding. Speech development is frequently affected, with children often exhibiting velopharyngeal insufficiency leading to hypernasal speech. Recurrent ear infections (otitis media) and associated conductive hearing loss are common due to eustachian tube dysfunction. Dental anomalies, including missing, malformed, or supernumerary teeth, are frequently observed in the cleft area. The condition may also have significant psychosocial impacts related to facial appearance. Most cases of cleft lip with cleft palate are nonsyndromic (isolated), arising from a complex interplay of genetic susceptibility and environmental factors (multifactorial inheritance). However, cleft lip/palate can also occur as part of over 300 recognized genetic syndromes. Treatment involves a coordinated, multidisciplinary approach typically beginning in infancy. Surgical repair of the lip (cheiloplasty) is usually performed around 3–6 months of age, and palate repair (palatoplasty) is generally completed by 12–18 months. Additional interventions may include orthodontic treatment, alveolar bone grafting, speech therapy, audiological monitoring, and sometimes secondary surgical revisions. With comprehensive care from a cleft team, most individuals achieve good functional and aesthetic outcomes.

Data sourced from FDA regulatory filings and ClinicalTrials.gov. Updated periodically.

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