Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Three Dimensional Facial Growth Analysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03514563
Recruitment Status : Recruiting
First Posted : May 2, 2018
Last Update Posted : October 22, 2018
Sponsor:
Collaborator:
University of Dundee
Information provided by (Responsible Party):
Xinhui Ma, University of Hull

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.


Condition or disease Intervention/treatment
Cleft Lip and Palate Diagnostic Test: MRI imaging Diagnostic Test: Optical scan Diagnostic Test: 3D photography

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Three Dimensional Analysis of Maxillofacial Growth in Patients With Cleft Lip and Palate
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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").

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Scotland
Criteria

Inclusion Criteria:

  • Selection according to malocclusion characteristics.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514563


Contacts
Layout table for location contacts
Contact: Xinhui Ma, PhD +44(0)1482462170 xinhui.ma@hull.ac.uk
Contact: Peter Mossey, PhD +44 (0)1382381 643 p.a.mossey@dundee.ac.uk

Locations
Layout table for location information
United Kingdom
University of Dundee Dental Hospital Recruiting
Dundee, Scotland, United Kingdom, DD1 4HR
Contact: Peter Mossey, PhD         
Sponsors and Collaborators
University of Hull
University of Dundee
Investigators
Layout table for investigator information
Study Chair: Michael Fagan, PhD University of Hull
Study Chair: Grant McIntyre, PhD University of Dundee

Additional Information:

Publications:

Layout table for additonal information
Responsible Party: Xinhui Ma, Lecturer, University of Hull
ClinicalTrials.gov Identifier: NCT03514563     History of Changes
Other Study ID Numbers: Protocol V1 6th September 2017
205923/Z/17/Z ( Other Grant/Funding Number: Wellcome Trust )
231096 ( Other Identifier: IRAS )
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xinhui Ma, University of Hull:
Cleft Lip and Palate
Maxillofacial
Growth
3D
Additional relevant MeSH terms:
Layout table for MeSH terms
Cleft Lip
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities