Three Dimensional Facial Growth Analysis

NCT03514563 | Terminated DMC

• 3 other identifiers: Protocol V1 6th September 2017205923/Z/17/Z231096
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Cleft Lip and Palate

Keywords

Cleft Lip and Palate; Maxillofacial; Growth; 3D

Outcome Measures

Primary Outcomes (1)

• Identification of landmarks and growth quantities

  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 Outcomes (2)

• Patient attitudes on MRI

  August 2019

• Patient attitudes on surgical timing

  August 2019

Study Arms (3)

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; Diagnostic Test: Optical scan; Diagnostic Test: 3D photography

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; Diagnostic Test: Optical scan; Diagnostic Test: 3D photography

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; Diagnostic Test: Optical scan; Diagnostic Test: 3D photography

Interventions

MRI imaging DIAGNOSTIC_TEST

MRI recordings of the craniofacial region

Group A; Group B; Group C

Optical scan DIAGNOSTIC_TEST

Optical intraoral scans

Group A; Group B; Group C

3D photography DIAGNOSTIC_TEST

Facial stereophotogrammetry

Group A; Group B; Group C

Eligibility Criteria

• Age: 12 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Scotland

You may qualify if:

• Selection according to malocclusion characteristics.

You may not qualify if:

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

Sponsors & Collaborators

• University of Hull: lead
• University of Dundee: collaborator

Study Sites (1)

University of Dundee Dental Hospital

Dundee, Scotland, DD1 4HR, United Kingdom

Location

Related Publications (9)

• Martin CB, Ma X, McIntyre GT, Wang W, Lin P, Chalmers EV, Mossey PA. The validity and reliability of an automated method of scoring dental arch relationships in unilateral cleft lip and palate using the modified Huddart-Bodenham scoring system. Eur J Orthod. 2016 Aug;38(4):353-8. doi: 10.1093/ejo/cjw031. Epub 2016 Apr 22.

  PMID: 27105652 BACKGROUND

• Ma X, Martin C, McIntyre G, Lin P, Mossey P. Digital Three-Dimensional Automation of the Modified Huddart and Bodenham Scoring System for Patients With Cleft Lip and Palate. Cleft Palate Craniofac J. 2017 Jul;54(4):481-486. doi: 10.1597/15-340. Epub 2016 May 2.

  PMID: 27136074 BACKGROUND

• Chalmers EV, McIntyre GT, Wang W, Gillgrass T, Martin CB, Mossey PA. Intraoral 3D Scanning or Dental Impressions for the Assessment of Dental Arch Relationships in Cleft Care: Which is Superior? Cleft Palate Craniofac J. 2016 Sep;53(5):568-77. doi: 10.1597/15-036. Epub 2015 Dec 1.

  PMID: 26623548 BACKGROUND

• Dobbyn L, Gillgrass T, McIntyre G, Macfarlane T, Mossey P. Validating the Clinical Use of the Modified Huddart and Bodenham Scoring System for Outcome in Cleft Lip and/or Palate. Cleft Palate Craniofac J. 2015 Nov;52(6):671-5. doi: 10.1597/12-170. Epub 2013 Aug 6.

  PMID: 23919521 BACKGROUND

• Garg P, Ludwig KU, Bohmer AC, Rubini M, Steegers-Theunissen R, Mossey PA, Mangold E, Sharp AJ. Genome-wide analysis of parent-of-origin effects in non-syndromic orofacial clefts. Eur J Hum Genet. 2014 Jun;22(6):822-30. doi: 10.1038/ejhg.2013.235. Epub 2013 Oct 30.

  PMID: 24169523 BACKGROUND

• Kasaven CP, McIntyre GT, Mossey PA. Accuracy of both virtual and printed 3-dimensional models for volumetric measurement of alveolar clefts before grafting with alveolar bone compared with a validated algorithm: a preliminary investigation. Br J Oral Maxillofac Surg. 2017 Jan;55(1):31-36. doi: 10.1016/j.bjoms.2016.08.016. Epub 2016 Sep 5.

  PMID: 27608534 BACKGROUND

• McBride WA, McIntyre GT, Carroll K, Mossey PA. Subphenotyping and Classification of Orofacial Clefts: Need for Orofacial Cleft Subphenotyping Calls for Revised Classification. Cleft Palate Craniofac J. 2016 Sep;53(5):539-49. doi: 10.1597/15-029. Epub 2015 Jul 14.

  PMID: 26171570 BACKGROUND

• Shaw K, McIntyre G, Mossey P, Menhinick A, Thomson D. Validation of conventional 2D lateral cephalometry using 3D cone beam CT. J Orthod. 2013 Mar;40(1):22-8. doi: 10.1179/1465313312Y.0000000009.

  PMID: 23524544 BACKGROUND

• Pinheiro M, Ma X, Fagan MJ, McIntyre GT, Lin P, Sivamurthy G, Mossey PA. A 3D cephalometric protocol for the accurate quantification of the craniofacial symmetry and facial growth. J Biol Eng. 2019 May 17;13:42. doi: 10.1186/s13036-019-0171-6. eCollection 2019.

  PMID: 31131023 RESULT

MeSH Terms

Conditions

Cleft Lip

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Michael Fagan, PhD

  University of Hull

  STUDY CHAIR

• Grant McIntyre, PhD

  University of Dundee

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 2, 2018
• Study Start: June 1, 2018
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2021
• Last Updated: November 4, 2021

Record last verified: 2021-10

Locations

GB (1)