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

March 12, 2024 updated by: Benito Benitez, University Hospital, Basel, Switzerland

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
      • Warsaw, Poland, 01-211
        • Institute of Mother and Child

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 1 year (Child)

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • patients with orofacial cleft, who undergo routine cleft repair

Exclusion Criteria:

  • missing datasets
  • no signed consent for research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Capture of the cleft morphology with photo and intraoral camera before routine surgery at around 8 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Capture of the cleft morphology with photo and intraoral camera before routine surgery at around 8 months.
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
At 3 months postoperative
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
At surgery and at 3 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

Institute of Mother and Child, Warsaw, Poland

Investigators

  • Principal Investigator: Benito K Benitez, MD DMD, University and University Hospital of Basel
  • Principal Investigator: Andrzej Brudnicki, MD DDS PhD, Maxillo-facial Surgery Unit, Pediatric Surgery Clinic, Institute of Mother and Child

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2020

Primary Completion (Actual)

May 17, 2022

Study Completion (Actual)

March 8, 2024

Study Registration Dates

First Submitted

October 25, 2020

First Submitted That Met QC Criteria

October 29, 2020

First Posted (Actual)

November 5, 2020

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Warsaw/Basel
  • ch20Benitez (Other Identifier: Department of Clinical Research Basel)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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