Cleft Lip and Palate Treatment Outcomes Study

Presurgical infant orthopedic (PSIO) treatment is widely used to improve alveolar alignment, nasal symmetry, and soft tissue relationships before primary repair in infants with cleft lip and palate. Standard of care approaches include lip taping, nasoalveolar molding (NAM), and other prefabricated systems. Treatment selection is individualized according to each infant's clinical presentation and family circumstances rather than randomly assigned.

Although PSIO is widely practiced, limited prospective evidence compares the clinical outcomes of individualized standard of care treatment approaches in real-world clinical practice. This prospective observational cohort study will evaluate the clinical outcomes of individualized PSIO treatment provided as part of routine clinical care at the University of Florida College of Dentistry. Infants with cleft lip and palate will be prospectively enrolled and will receive lip taping, NAM, or prefabricated appliance, or no presurgical intervention according to clinical indications and family-specific factors. No investigational drugs, investigational devices, or research-only procedures will be used. Clinical outcomes, including alveolar alignment, cleft gap reduction, nasal symmetry, treatment efficiency, and family treatment burden, will be assessed using routinely collected clinical records, photographs, and treatment data. The findings will provide evidence to support individualized, evidence-based treatment planning for PSIO care.

Inclusion criteria

• Diagnosis of cleft lip and or palate with clinical indication for presurgical infant orthopedic treatment
• Age appropriate for presurgical infant orthopedic treatment, generally from birth until surgical repair
• Parent or guardian ability to provide consent
• Willingness to comply with follow up visits to the extent feasible given family circumstances

Exclusion criteria

• Other craniofacial syndromes requiring a substantially different management protocol
• Anticipated inability to complete any follow up
• Lack of parental consent