Cleft Lip and Palate Treatment Outcomes Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cleft Lip and Palate. Basic parameters: 1 Day — 12 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Outcomes of Individualized Presurgical Infant Orthopedic Treatment Approaches in Infants With Cleft Lip and Palate
Overview
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.
Primary outcome measures
- Change in alveolar segment alignment [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 [Time frame: Baseline, at each routine follow-up visit during PSIO treatment, and immediately before primary lip repair (approximately 3-5 months).]
- Treatment completion [Time frame: At primary lip repair (approximately 3-5 months after initiation of PSIO).]
Secondary outcome measures (5)
- Number of clinic visits during PSIO treatment [Time frame: From initiation of PSIO treatment to primary lip repair (approximately 3-5 months)]
- Duration of PSIO treatment [Time frame: From initiation of PSIO treatment to primary lip repair (approximately 3-5 months)]
- Number of appliance modifications [Time frame: From initiation of PSIO treatment to primary lip repair (approximately 3-5 months)]
- Caregiver compliance [Time frame: Initial visiting date to primary lip repair (approximately 3-5 months)]
- Number of treatment-related adverse events [Time frame: From initiation of PSIO treatment to primary lip repair (approximately 3-5 months)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Perez Rivera LR, Tanikawa DYS, Chong DK, Flores RL, Shetye PR. A Comparative Assessment of Surgeon Appraisal of Presurgical Infant Orthopedics Outcomes Using PLANA and NAM. J Craniofac Surg. 2026 Jul-Aug 01;37(7-8):2128-2132. doi: 10.1097/SCS.0000000000012753. Epub 2026 Apr 6. PMID 41940938
- Tanikawa DYS, Figueroa AA. "Comparative Effectiveness of PLANA and Nasal Elevator in Presurgical Orthopedics: A 3D Anthropometric Study of Unilateral Cleft Lip.". Plast Reconstr Surg. 2026 May 20. doi: 10.1097/PRS.0000000000013220. Online ahead of print. PMID 42160712
Identifiers
NCT: NCT07687537 · IRB202600950