Infants with cleft lip and palate often benefit from presurgical infant orthopedic treatment before surgical repair. Multiple standard of care approaches are selected based on each infant's clinical presentation and family circumstances. This prospective observational cohort study will evaluate clinical outcomes, treatment efficiency, and family burden using routinely collected clinical records and photographs to support individualized, evidence-based PSIO treatment planning.
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.
Study Type
OBSERVATIONAL
Enrollment
100
Change in alveolar segment alignment
Measured on standardized dental model or directly in the mouth using linear measurements (mm).
Time frame: Baseline, at each routine follow-up visit during PSIO treatment, and immediately before primary lip repair (approximately 3-5 months).
Change in nasal symmetry
Measured from standardized frontal and basal clinical photographs using anthropometric analysis.
Time frame: Baseline, at each routine follow-up visit during PSIO treatment, and immediately before primary lip repair (approximately 3-5 months).
Treatment completion
Percentage of participants completing individualized PSIO treatment before primary lip repair.
Time frame: At primary lip repair (approximately 3-5 months after initiation of PSIO).
Number of clinic visits during PSIO treatment
Total number of scheduled clinical visits required from initiation of PSIO treatment to primary lip repair.
Time frame: From initiation of PSIO treatment to primary lip repair (approximately 3-5 months)
Duration of PSIO treatment
Number of days from initiation of PSIO treatment until primary lip repair.
Time frame: From initiation of PSIO treatment to primary lip repair (approximately 3-5 months)
Number of appliance modifications
Total number of appliance adjustments with any issues or remakes required during PSIO treatment.
Time frame: From initiation of PSIO treatment to primary lip repair (approximately 3-5 months)
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Caregiver compliance
Percentage of scheduled appointments attended and adherence to prescribed appliance wear documented in clinical records.
Time frame: Initial visiting date to primary lip repair (approximately 3-5 months)
Number of treatment-related adverse events
Number of participants experiencing treatment-related adverse events, including appliance-related complications, oral mucosal irritation, and unplanned appliance modifications.
Time frame: From initiation of PSIO treatment to primary lip repair (approximately 3-5 months)