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Three Dimensional Facial Growth Analysis

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03514563
Enrollment
1
Registered
2018-05-02
Start date
2018-06-01
Completion date
2021-08-31
Last updated
2021-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleft Lip and Palate

Keywords

Cleft Lip and Palate, Maxillofacial, Growth, 3D

Brief 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.

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.

Interventions

DIAGNOSTIC_TESTMRI imaging

MRI recordings of the craniofacial region

DIAGNOSTIC_TESTOptical scan

Optical intraoral scans

DIAGNOSTIC_TEST3D photography

Facial stereophotogrammetry

Sponsors

University of Dundee
CollaboratorOTHER
University of Hull
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to 13 Years
Healthy volunteers
No

Inclusion criteria

* Selection according to malocclusion characteristics.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Identification of landmarks and growth quantitiesAugust 2019Identification 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.

Secondary

MeasureTime frameDescription
Patient attitudes on MRIAugust 2019Patient 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).
Patient attitudes on surgical timingAugust 2019Patient attitudes on the issue of delayed surgical intervention and whether they prefer the concept of early surgery or waiting until later.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026