Cleft Lip and PalateNCT07687537
Cleft Lip and Palate Treatment Outcomes Study
An observational study of Cleft Lip and Palate, run by University of Florida.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 12 months
- Conditions the study is for
- Cleft Lip and Palate
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 31 Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 12 months
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- Other craniofacial syndromes requiring a substantially different management protocol
- Anticipated inability to complete any follow up
- Lack of parental consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Outcomes of Individualized Presurgical Infant Orthopedic Treatment Approaches in Infants With Cleft Lip and Palate
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.
Read the 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.
- Conditions
- Cleft Lip and Palate
- Keywords
- Presurgical Infant Orthopedics, Nasoalveolar Molding, Cleft Lip and Palate, Lip Taping, Prefabricated Systems
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in alveolar segment alignment
Measured on standardized dental model or directly in the mouth using linear measurements (mm).
Measured: 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.
Measured: 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.
Measured: At primary lip repair (approximately 3-5 months after initiation of PSIO).
Secondary outcomes (5)
Number of clinic visits during PSIO treatment
Total number of scheduled clinical visits required from initiation of PSIO treatment to primary lip repair.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From initiation of PSIO treatment to primary lip repair (approximately 3-5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cleft Lip and PalateStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687537
- Sponsor's protocol ID
- IRB202600950
- Status last verified
- Jun 2026
- First submitted
- 26 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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.
PubMed 41940938Tanikawa 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.
PubMed 42160712
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Individualized Presurgical Infant Orthopedic Treatment Approaches in Infants With Cleft Lip and Palate
- ClinicalTrials.gov ID
- NCT07687537
- Acronym / sponsor ID
- IRB202600950
- Conditions
- Cleft Lip and Palate
- Keywords
- Presurgical Infant Orthopedics, Nasoalveolar Molding, Cleft Lip and Palate, Lip Taping, Prefabricated Systems
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 day to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Other craniofacial syndromes requiring a substantially different management protocol
- Anticipated inability to complete any follow up
- Lack of parental consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Measured on standardized dental model or directly in the mouth using linear measurements (mm).
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).
Measured from standardized frontal and basal clinical photographs using anthropometric analysis.
Treatment completion
Time frame: At primary lip repair (approximately 3-5 months after initiation of PSIO).
Percentage of participants completing individualized PSIO treatment before primary lip repair.
5 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Background: PubMed 41940938Perez 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.
- Background: PubMed 42160712Tanikawa 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Cleft Lip and Palate, run by University of Florida.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mi Sook Lee, DMD, MSD, PhD (352-273-7631, misooklee@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07687537, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.