Cleft Lip and Palate Treatment Outcomes Study

NCT07687537 | Not Yet Recruiting

• 1 other identifier: IRB202600950
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cleft Lip and Palate

Keywords

Presurgical Infant Orthopedics; Nasoalveolar Molding; Cleft Lip and Palate; Lip Taping; Prefabricated Systems

Outcome Measures

Primary Outcomes (3)

• Change in alveolar segment alignment

  Measured on standardized dental model or directly in the mouth using linear measurements (mm).

  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.

  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.

  At primary lip repair (approximately 3-5 months after initiation of PSIO).

Secondary Outcomes (5)

• Number of clinic visits during PSIO treatment

  From initiation of PSIO treatment to primary lip repair (approximately 3-5 months)

• Duration of PSIO treatment

  From initiation of PSIO treatment to primary lip repair (approximately 3-5 months)

• Number of appliance modifications

  From initiation of PSIO treatment to primary lip repair (approximately 3-5 months)

• Caregiver compliance

  Initial visiting date to primary lip repair (approximately 3-5 months)

• Number of treatment-related adverse events

  From initiation of PSIO treatment to primary lip repair (approximately 3-5 months)

Study Arms (1)

Infants with Cleft Lip and Palate Receiving Presurgical Infant Orthopedics

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.

Eligibility Criteria

• Age: 1 Day - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• Other craniofacial syndromes requiring a substantially different management protocol
• Anticipated inability to complete any follow up
• Lack of parental consent

Sponsors & Collaborators

• University of Florida: lead

Related Publications (2)

• 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 Apr 6. doi: 10.1097/SCS.0000000000012753. Online ahead of print.

  PMID: 41940938 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Cleft Lip

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Mi Sook Lee, DMD, MSD, PhD

CONTACT

352-273-7631; misooklee@ufl.edu

Marcio Guelmann, DDS

CONTACT

352-273-7635; guelmann@ufl.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 7, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2029
• Last Updated: July 7, 2026

Record last verified: 2026-06