An observational study in Cleft Lip and Palate, sponsored by University of Florida. Not yet recruiting. Open to participants aged 1 Day to 12 Months. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by University of Florida · Observational
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.
168 studies on the registry are indexed under Cleft Lip; 51 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 49 observational studies indexed under Cleft Lip.
Browse Cleft Lip studies →University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.
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Infants diagnosed with cleft lip and palate who receive presurgical infant orthopedic (PSIO) treatment at the Pediatric Dentistry, University of Florida. Participants will be enrolled prospectively during routine clinical care. Treatment approaches are selected by the treating clinicians based on each infant's clinical presentation and family circumstances rather than by the study protocol. Clinical outcome data will be collected prospectively during routine clinical care and follow-up visits.
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Exclusion Criteria
Infants diagnosed with cleft lip and palate who receive standard of care presurgical infant orthopedic (PSIO) treatment at the Pediatric Dentistry, University of Florida. PSIO treatment approaches, including lip taping, nasoalveolar molding (NAM), prefabricated systems, or combinations of these techniques, are selected according to each infant's clinical presentation and family circumstances as part of routine clinical care. This observational study does not assign treatment. Clinical outcomes are prospectively collected and compared among the different treatment approaches.
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)
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)
No study locations are listed for this record.
Plan to share: Undecided — The investigators have not yet determined whether individual participant data (IPD) will be shared with other researchers. Any future decision regarding data sharing will be made in accordance with University of Florida policies, applicable laws and regulations, Institutional Review Board (IRB) requirements, participant privacy protections, and HIPAA regulations. Any shared data, if applicable, will be de-identified.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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