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

Completed

• Conditions: Cleft Lip and Palate; Cleft Palate; Craniofacial Deformity

• Registration Number: NCT04616690
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-25
• Study First Submitted QC: 2020-10-29
• Study First Posted: 2020-11-05
• Study Start: 2020-12-07
• Primary Completion: 2022-05-17
• Status Verified: 2024-03
• Study Completion: 2024-03-08
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• patients with orofacial cleft, who undergo routine cleft repair

Exclusion Criteria

• missing datasets
• no signed consent for research

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.

Trial Locations

Locations (1)

Institute of Mother and Child; 🇵🇱 Warsaw, Poland