Three-dimensional Cleft Lip and Palate Morphology Prior to One-stage Cleft Repair

Collaborative, Comparative Study on Three-dimensional Cleft Lip and Palate Morphology Prior to One-stage Cleft Repair (Warsaw/Basel)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04616690

Enrollment

Registered

2020-11-05

Start date

2020-12-07

Completion date

2024-03-08

Last updated

2024-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleft Lip and Palate, Cleft Palate, Craniofacial Deformity

Keywords

Cleft Lip and Palate, Presurgical Orthopedics, Cleft Morphology, Palatal Plate

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Months to 15 Months

Healthy volunteers

Inclusion criteria

* patients with orofacial cleft, who undergo routine cleft repair

Exclusion criteria

* missing datasets * no signed consent for research

Design outcomes

Primary

Measure	Time frame	Description
True Cleft Area in mm2 of Newborns With Cleft Lip and Palate at 8 Month of Age	Capture of the cleft morphology with photo and intraoral camera before routine surgery at around 8 months.	True cleft area in mm2 will be measured at 8 month of age in newborns with cleft lip and palate.

Secondary

Measure	Time frame	Description
Cleft Width and Height in mm of Newborns With Cleft Lip and Palate at 8 Month of Age	Capture of the cleft morphology with photo and intraoral camera before routine surgery at around 8 months.	Measurement of the width and height in mm of the cleft measured at 8 months of age.
Wound Healing (fistula yes or no) 3 Months After One-Stage Cleft Repair	At 3 months postoperative	Assessment of wound healing by fistula formation at 3 months postoperative
Correlation of Cleft Width in mm and Wound Healing after One-Stage Cleft Repair	At surgery and at 3 months postoperative	Evaluation of the correlation between cleft width in mm and wound healing

Countries

Poland

Outcome results