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Three Dimensional Facial Growth Analysis

NCT03514563 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 1

Last updated 2021-11-04

No results posted yet for this study

Summary

Cleft lip and palate is the most common facial birth defect affecting one in 700 babies, and frequently leads to problems in feeding, breathing, speech and/or hearing, and aesthetic problems often leading to social and psychological problems. Poor growth of the upper jaw affects nearly all patients with the condition, and can result in substantial misalignment of the teeth requiring corrective surgery and associated dental treatment in early adulthood.

Surprisingly there is little evidence to support the current practice of delaying surgery until early adulthood. It is apparently left until then because it is assumed this is when the skull and face have stopped growing, but there is little available information on that growth and when the different parts of the face and skull stop growing.

The goal of this study is to develop and test new computer-based methods to quantify skull growth and related soft- tissues changes. This pilot work will demonstrate whether it is possible to measure these developments and prepare the tools for a larger clinical study. That clinical study will determine the full nature and extent of bone growth and related soft-tissue changes during late adolescence, to identify if/when earlier surgery could be carried out to correct any deformity and minimise the associated social stigmas of the condition.

Conditions

  • Cleft Lip and Palate

Interventions

DIAGNOSTIC_TEST

MRI imaging

MRI recordings of the craniofacial region

DIAGNOSTIC_TEST

Optical scan

Optical intraoral scans

DIAGNOSTIC_TEST

3D photography

Facial stereophotogrammetry

Sponsors & Collaborators

  • University of Dundee

    collaborator OTHER

  • University of Hull

    lead OTHER

Principal Investigators

  • Michael Fagan, PhD · University of Hull

  • Grant McIntyre, PhD · University of Dundee

Eligibility

Min Age
12 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2019-08-31
Completion
2021-08-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03514563 on ClinicalTrials.gov