Three Dimensional Facial Growth Analysis

October 27, 2021 updated by: Xinhui Ma, University of Hull

Three Dimensional Analysis of Maxillofacial Growth in Patients With Cleft Lip and Palate

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

OVERVIEW

The study will involve a three arm parallel cohort study considering patients with the following conditions:

  1. Class I malocclusion with no vertical facial anomalies, and no facial asymmetry or other pathology;
  2. Class III malocclusion with maxillary deficiency but no other vertical facial anomalies, and no facial asymmetry or other pathology;
  3. Patients with cleft lip and/or palate and a Class III malocclusion and no other pathology.

DATA CAPTURE

a. MRI data will be obtained (for 10 subjects in each group) at age T0 and one year afterwards (T1). This will provide accurate geometries to properly test the techniques. The use of MRI scan data avoids the need for unnecessary exposure of patients to ionizing radiation, it also allows the relationship between hard and soft tissues to be observed.

b. The same 10 patients in (a) will undergo an intra-oral scan captured using a Trios intraoral scanner (3Shape, Aarhus, Denmark) which uses ultrafast optical sectioning technology (non-invasive) to provide a 3D image of the dentition and dental occlusion and facial stereophotogrammetry scan (Vectra H1 3D camera) for soft-tissue texture information at ages T0 and T1.

3D DATA ANALYSIS

  1. Reconstructed 3D geometries of the MRI scans at ages T0 and T1 will be superimposed to determine the areas of skeletal and dental change in each subject. The scans will be reconstructed and processed for the downstream 3D volume subtraction, using the methodologies developed by the investigators and collaborators in similar dental and skull biomechanics applications The T0 data will then be subtracted from the T1 data to visualize and quantify the geometric changes in hard tissues arising from growth.
  2. To investigate the external changes in soft tissues, 3D stereophotogrammetry scans will be converted to shells. Colour-mapping will then provide quantification of the temporal change in the soft tissues by 3D subtraction. Furthermore, to quantify the changes in areas of complex-curvature e.g. the labiomental fold, 3D curvatures will be computed and differences analysed using methods developed by the investigators.
  3. To determine the growth correlation between soft- and hard-tissues, geometric morphometric algorithms and bespoke computational methods will be developed. Firstly, homologous landmarks will be identified automatically and 3D landmark templates will be created to capture the surface geometries. Thereafter, discriminant function analysis will be performed to compare the shape changes in each category for each age.
  4. The intraoral scans will also be converted to shells along with the hard- and soft-tissue information. Using Avizo software, subtraction and colour-mapping of the intraoral images will then again provide quantification of the temporal change in the occlusal relationships.

Study Type

Observational

Enrollment (Actual)

1

Contacts and Locations

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

Study Locations

  • United Kingdom
    • Scotland
      • Dundee, Scotland, United Kingdom, DD1 4HR
        • University of Dundee Dental Hospital

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

12 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Scotland

Description

Inclusion Criteria:

  • Selection according to malocclusion characteristics.

Exclusion Criteria:

  • Specific age 12-13 years, outside of which will be excluded.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
MRI imaging, Optical scan and 3D photography for patients with Class I (non-skeletal) malocclusion with no facial asymmetry or other pathology.
Diagnostic test: MRI imaging
MRI recordings of the craniofacial region
Diagnostic test: Optical scan
Optical intraoral scans
Diagnostic test: 3D photography
Facial stereophotogrammetry
Group B
MRI imaging, Optical scan and 3D photography for patients with Class III (skeletal-based) malocclusion with maxillary deficiency and normal vertical facial relationships, with no facial asymmetry or other pathology
Diagnostic test: MRI imaging
MRI recordings of the craniofacial region
Diagnostic test: Optical scan
Optical intraoral scans
Diagnostic test: 3D photography
Facial stereophotogrammetry
Group C
MRI imaging, Optical scan and 3D photography for patients with Cleft lip and/or palate and a Class III malocclusion and no other pathology
Diagnostic test: MRI imaging
MRI recordings of the craniofacial region
Diagnostic test: Optical scan
Optical intraoral scans
Diagnostic test: 3D photography
Facial stereophotogrammetry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of landmarks and growth quantities
Time Frame: August 2019
Identification of homologous landmarks characterising skeletal, soft tissue and dental change during facial growth; Identification of optimal methods accurately quantifying skeletal, soft tissue and dental change during facial growth.
August 2019

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient attitudes on MRI
Time Frame: August 2019
Patient attitudes on the use of magnetic resonance imaging (MRI) as an imaging modality to assess facial growth, including the practicalities and comfort of the MRI recording (and the use of a "wax bite").
August 2019
Patient attitudes on surgical timing
Time Frame: August 2019
Patient attitudes on the issue of delayed surgical intervention and whether they prefer the concept of early surgery or waiting until later.
August 2019

Collaborators and Investigators

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

Sponsor

University of Hull

Collaborators

University of Dundee

Investigators

  • Study Chair: Michael Fagan, PhD, University of Hull
  • Study Chair: Grant McIntyre, PhD, University of Dundee

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)

June 1, 2018

Primary Completion (Actual)

August 31, 2019

Study Completion (Actual)

August 31, 2021

Study Registration Dates

First Submitted

April 26, 2018

First Submitted That Met QC Criteria

May 1, 2018

First Posted (Actual)

May 2, 2018

Study Record Updates

Last Update Posted (Actual)

November 4, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protocol V1 6th September 2017
  • 205923/Z/17/Z (Other Grant/Funding Number: Wellcome Trust)
  • 231096 (Other Identifier: IRAS)

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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