Clinical trial NCT04616690: Three-dimensional Cleft Lip and Palate Morphology Prior to One-stage Cleft Repair
Official title: Collaborative, Comparative Study on Three-dimensional Cleft Lip and Palate Morphology Prior to One-stage Cleft Repair (Warsaw/Basel)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cleft Lip and Palate
Cleft Palate
Craniofacial Deformity
Keywords: Cleft Lip and Palate
Presurgical Orthopedics
Cleft Morphology
Palatal Plate
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Institute of Mother and Child, Warsaw, Poland
First posted: 2020-11-05
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients eligible for this study must have an orofacial cleft which has to be treated around the age of 6-15 months.

Brief summary: This is a prospective observational cohort study of consecutive patients with cleft lip and palate deformity undergoing cleft repair at the Institute of Mother and Child in Warsaw. Cleft morphology will be captured with photo and intraoral camera before routine surgery at around 8 months. Furthermore, wound healing at 3 months postoperative will be assessed.


Eligibility criteria: Inclusion Criteria:

* patients with orofacial cleft, who undergo routine cleft repair

Exclusion Criteria:

* missing datasets
* no signed consent for research

Primary outcomes:
measure: True Cleft Area in mm2 of Newborns With Cleft Lip and Palate at 8 Month of Age
timeFrame: Capture of the cleft morphology with photo and intraoral camera before routine surgery at around 8 months.
Secondary outcomes:
measure: Cleft Width and Height in mm of Newborns With Cleft Lip and Palate at 8 Month of Age
timeFrame: Capture of the cleft morphology with photo and intraoral camera before routine surgery at around 8 months.
measure: Wound Healing (fistula yes or no) 3 Months After One-Stage Cleft Repair
timeFrame: At 3 months postoperative
measure: Correlation of Cleft Width in mm and Wound Healing after One-Stage Cleft Repair
timeFrame: At surgery and at 3 months postoperative
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Institute of Mother and Child
Study officials:
affiliation: University and University Hospital of Basel
name: Benito K Benitez, MD DMD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maxillo-facial Surgery Unit, Pediatric Surgery Clinic, Institute of Mother and Child
name: Andrzej Brudnicki, MD DDS PhD
role: PRINCIPAL_INVESTIGATOR
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