Skip to main content
OpenTrials
Completed

NCT Number: NCT04616690

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cleft Lip and Palate Cleft Lip Cleft Palate Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Craniofacial Deformity Jaw Abnormalities Jaw Diseases Lip Diseases Maxillofacial Abnormalities Mouth Abnormalities Mouth Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

6 month–15 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Mother and Child

Warsaw, 01-211, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with orofacial cleft, who undergo routine cleft repair

Exclusion criteria

  • missing datasets
  • no signed consent for research

Treatment and study plan

Primary outcomes

  1. True Cleft Area in mm2 of Newborns With Cleft Lip and Palate at 8 Month of Age

    Time frame: 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 outcomes

  1. Cleft Width and Height in mm of Newborns With Cleft Lip and Palate at 8 Month of Age

    Time frame: 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.

  2. Wound Healing (fistula yes or no) 3 Months After One-Stage Cleft Repair

    Time frame: At 3 months postoperative

    Assessment of wound healing by fistula formation at 3 months postoperative

  3. Correlation of Cleft Width in mm and Wound Healing after One-Stage Cleft Repair

    Time frame: At surgery and at 3 months postoperative

    Evaluation of the correlation between cleft width in mm and wound healing

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Institute of Mother and Child, Warsaw, Poland

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2024
First posted
Nov 5, 2020
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.