Cleft palate

Cleft palate (CP) is a congenital malformation characterized by an opening or split in the roof of the mouth (palate) that occurs when the palatal shelves fail to fuse properly during embryonic development, typically between the 6th and 12th weeks of gestation. It may involve the soft palate alone (incomplete cleft palate), or extend through both the soft and hard palate (complete cleft palate). Cleft palate can occur as an isolated anomaly (non-syndromic) or as part of a broader genetic syndrome (syndromic), such as Pierre Robin sequence, velocardiofacial syndrome (22q11.2 deletion syndrome), or Stickler syndrome, among many others. The condition is present at birth and is typically diagnosed in the neonatal period. Cleft palate primarily affects the craniofacial system but has significant functional consequences for feeding, speech, hearing, and dental development. Newborns with cleft palate often have difficulty with breastfeeding and bottle-feeding due to the inability to generate adequate suction, requiring specialized feeding techniques or devices. As children grow, speech development is frequently affected, with velopharyngeal insufficiency leading to hypernasal speech. Recurrent middle ear infections (otitis media) and conductive hearing loss are common due to Eustachian tube dysfunction. Dental anomalies, including missing or malpositioned teeth, are also frequently observed. Treatment of cleft palate requires a multidisciplinary approach involving plastic surgeons, otolaryngologists, speech-language pathologists, audiologists, orthodontists, and geneticists. Surgical repair (palatoplasty) is the primary treatment and is typically performed between 9 and 18 months of age to optimize speech development. Some patients require additional surgeries, such as pharyngoplasty or secondary palatal procedures, to address persistent velopharyngeal insufficiency. Speech therapy is often necessary, and ear tube placement (myringotomy with tympanostomy tubes) may be needed to manage recurrent ear infections and hearing loss. With appropriate multidisciplinary care, most individuals with cleft palate achieve good functional and cosmetic outcomes. Genetic counseling is recommended, particularly when the cleft palate occurs as part of a syndrome, to assess recurrence risk and identify associated conditions.

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

Common questions about Cleft palate