Cleft Lip and Palate
Conditions
Keywords
Presurgical Infant Orthopedics, Nasoalveolar Molding, Cleft Lip and Palate, Lip Taping, Prefabricated Systems
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
University of Florida
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Days to 12 Months
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of cleft lip and or palate with clinical indication for presurgical infant orthopedic treatment 2. Age appropriate for presurgical infant orthopedic treatment, generally from birth until surgical repair 3. Parent or guardian ability to provide consent 4. Willingness to comply with follow up visits to the extent feasible given family circumstances
Exclusion criteria
1. Other craniofacial syndromes requiring a substantially different management protocol 2. Anticipated inability to complete any follow up 3. Lack of parental consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in alveolar segment alignment | Baseline, at each routine follow-up visit during PSIO treatment, and immediately before primary lip repair (approximately 3-5 months). | Measured on standardized dental model or directly in the mouth using linear measurements (mm). |
| Change in nasal symmetry | Baseline, at each routine follow-up visit during PSIO treatment, and immediately before primary lip repair (approximately 3-5 months). | Measured from standardized frontal and basal clinical photographs using anthropometric analysis. |
| Treatment completion | At primary lip repair (approximately 3-5 months after initiation of PSIO). | Percentage of participants completing individualized PSIO treatment before primary lip repair. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of clinic visits during PSIO treatment | From initiation of PSIO treatment to primary lip repair (approximately 3-5 months) | Total number of scheduled clinical visits required from initiation of PSIO treatment to primary lip repair. |
| Duration of PSIO treatment | From initiation of PSIO treatment to primary lip repair (approximately 3-5 months) | Number of days from initiation of PSIO treatment until primary lip repair. |
| Number of appliance modifications | From initiation of PSIO treatment to primary lip repair (approximately 3-5 months) | Total number of appliance adjustments with any issues or remakes required during PSIO treatment. |
| Caregiver compliance | Initial visiting date to primary lip repair (approximately 3-5 months) | Percentage of scheduled appointments attended and adherence to prescribed appliance wear documented in clinical records. |
| Number of treatment-related adverse events | From initiation of PSIO treatment to primary lip repair (approximately 3-5 months) | Number of participants experiencing treatment-related adverse events, including appliance-related complications, oral mucosal irritation, and unplanned appliance modifications. |
Contacts
CONTACTMi Sook Lee, DMD, MSD, PhD
CONTACTMarcio Guelmann, DDS
Outcome results
None listed