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| ID | Type | Description | Link |
|---|---|---|---|
| 205923/Z/17/Z | Other Grant/Funding Number | Wellcome Trust | |
| 231096 | Other Identifier | IRAS |
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Due to Covid-19 pandemic
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| Name | Class |
|---|---|
| University of Dundee | OTHER |
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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.
OVERVIEW
The study will involve a three arm parallel cohort study considering patients with the following conditions:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | MRI imaging, Optical scan and 3D photography for patients with Class I (non-skeletal) malocclusion with no facial asymmetry or other pathology. |
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| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI imaging | Diagnostic Test | MRI recordings of the craniofacial region |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient attitudes on MRI | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Scotland
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| Name | Affiliation | Role |
|---|---|---|
| Michael Fagan, PhD | University of Hull | Study Chair |
| Grant McIntyre, PhD | University of Dundee | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Dundee Dental Hospital | Dundee | Scotland | DD1 4HR | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27105652 | Background | 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. | |
| 27136074 |
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| ID | Term |
|---|---|
| D002971 | Cleft Lip |
| ID | Term |
|---|---|
| D008047 | Lip Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D009056 | Mouth Abnormalities |
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| Optical scan | Diagnostic Test | Optical intraoral scans |
|
| 3D photography | Diagnostic Test | Facial stereophotogrammetry |
|
Patient attitudes on the issue of delayed surgical intervention and whether they prefer the concept of early surgery or waiting until later. |
| August 2019 |
| 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. |
| 26623548 | 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. |
| 23919521 | 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. |
| 24169523 | 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. |
| 27608534 | 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. |
| 26171570 | 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. |
| 23524544 | 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. |
| 31131023 | Result | 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. |
| D018640 |
| Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |