Cleft Lip and Palate Treatment Outcomes Study
ConditionCleft Lip and Palate
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-12
SponsorUniversity of Florida
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Other craniofacial syndromes requiring a substantially different management protocol
Anticipated inability to complete any follow up
Lack of parental consent
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: Infants with Cleft Lip and Palate Receiving Presurgical Infant Orthopedics
Trial outcomes
Primary outcomes
1
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).2
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).3
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).Secondary outcomes
1
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)2
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)3
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)4
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)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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