Cleft Lip and PalateNCT03514563
Three Dimensional Facial Growth Analysis
An observational study of Cleft Lip and Palate, run by University of Hull at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 13 years
- Conditions the study is for
- Cleft Lip and Palate
- What is being tested?
- MRI imaging, Optical scan and 3D photography
- How many people
- 1 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2018to 31 Aug 2021
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 13 years
- All sexes
- No healthy volunteers
- Child
Study population: Scotland
Who may be able to join
- Selection according to malocclusion characteristics.
Who cannot join
- Specific age 12-13 years, outside of which will be excluded.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Dundee Dental Hospital
Dundee, Scotland, DD1 4HR
About this study
Official title: 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.
Read the detailed description
OVERVIEW
The study will involve a three arm parallel cohort study considering patients with the following conditions:
- Class I malocclusion with no vertical facial anomalies, and no facial asymmetry or other pathology;
- Class III malocclusion with maxillary deficiency but no other vertical facial anomalies, and no facial asymmetry or other pathology;
- Patients with cleft lip and/or palate and a Class III malocclusion and no other pathology.
DATA CAPTURE
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- Conditions
- Cleft Lip and Palate
- Being tested
- MRI imaging, Optical scan, 3D photography
- Keywords
- Cleft Lip and Palate, Maxillofacial, Growth, 3D
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI imagingDiagnostic test
MRI recordings of the craniofacial region
Optical scanDiagnostic test
Optical intraoral scans
3D photographyDiagnostic test
Facial stereophotogrammetry
| Study group | Role | What they receive |
|---|---|---|
| Group A | MRI imaging, Optical scan and 3D photography for patients with Class I (non-skeletal) malocclusion with no facial asymmetry or other pathology. Receives: 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 Receives: 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 Receives: Diagnostic Test: MRI imaging; Diagnostic Test: Optical scan; Diagnostic Test: 3D photography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: August 2019
Secondary outcomes (2)
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").
Measured: August 2019
Patient attitudes on surgical timing
Patient attitudes on the issue of delayed surgical intervention and whether they prefer the concept of early surgery or waiting until later.
Measured: August 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start1 Jun 2018
- Primary completion31 Aug 2019
- Study completion31 Aug 2021
Why it stopped: Due to Covid-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Cleft Lip and PalateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Hull
- Sponsor type
- University, hospital or other
- Collaborators
- University of Dundee
- Responsible party
- Principal investigator, Xinhui Ma, University of Hull
- Investigators
- Michael Fagan, PhD, Study chair, University of HullGrant McIntyre, PhD, Study chair, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514563
- Sponsor's protocol ID
- Protocol V1 6th September 2017
- Other IDs
- 205923/Z/17/Z, 231096
- Status last verified
- Oct 2021
- First submitted
- 26 Apr 2018
- Last updated
- 4 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27105652Ma 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.
PubMed 27136074Chalmers 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.
PubMed 26623548Dobbyn 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.
PubMed 23919521Garg 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.
PubMed 24169523Kasaven 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.
PubMed 27608534McBride 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.
PubMed 26171570Shaw 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.
PubMed 23524544Pinheiro 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.
PubMed 31131023
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Dimensional Analysis of Maxillofacial Growth in Patients With Cleft Lip and Palate
- ClinicalTrials.gov ID
- NCT03514563
- Acronym / sponsor ID
- Protocol V1 6th September 2017
- Conditions
- Cleft Lip and Palate
- Keywords
- Cleft Lip and Palate, Maxillofacial, Growth, 3D
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to Covid-19 pandemic
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of HullUniversity, hospital or other
- Collaborators
- University of Dundee
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 2 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Class I malocclusion with no vertical facial anomalies, and no facial asymmetry or other pathology;
- Class III malocclusion with maxillary deficiency but no other vertical facial anomalies, and no facial asymmetry or other pathology;
- Patients with cleft lip and/or palate and a Class III malocclusion and no other pathology.
DATA CAPTURE
- 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.
- 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
- 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.
- 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.
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Diagnostic Test: MRI imaging, Diagnostic Test: Optical scan, Diagnostic Test: 3D photographyMRI imaging, Optical scan and 3D photography for patients with Class I (non-skeletal) malocclusion with no facial asymmetry or other pathology. |
| Group B | – | Diagnostic Test: MRI imaging, Diagnostic Test: Optical scan, Diagnostic Test: 3D photographyMRI 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 |
| Group C | – | Diagnostic Test: MRI imaging, Diagnostic Test: Optical scan, Diagnostic Test: 3D photographyMRI imaging, Optical scan and 3D photography for patients with Cleft lip and/or palate and a Class III malocclusion and no other pathology |
Who may qualify
- Ages
- 12 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Scotland
Key inclusion criteria (1 listed)
- Selection according to malocclusion characteristics.
Key exclusion criteria (1 listed)
- Specific age 12-13 years, outside of which will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI imagingMRI recordings of the craniofacial region | Diagnostic test | Group A, Group B, Group C |
| Optical scanOptical intraoral scans | Diagnostic test | Group A, Group B, Group C |
| 3D photographyFacial stereophotogrammetry | Diagnostic test | Group A, Group B, Group C |
Primary outcome
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.
2 secondary outcomes
Patient attitudes on MRI
Time frame: August 2019
Patient attitudes on surgical timing
Time frame: August 2019
Results and safety
The study was stopped early (reason given: Due to Covid-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Background: PubMed 27105652Martin 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.
- Background: PubMed 27136074Ma 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.
- Background: PubMed 26623548Chalmers 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.
- Background: PubMed 23919521Dobbyn 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.
- Background: PubMed 24169523Garg 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.
- Background: PubMed 27608534Kasaven 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.
- Background: PubMed 26171570McBride 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.
- Background: PubMed 23524544Shaw 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.
- Results publication: PubMed 31131023Pinheiro 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Fagan, PhD study chair
University of Hull
Grant McIntyre, PhD study chair
University of Dundee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cleft Lip and Palate, run by University of Hull at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to Covid-19 pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of landmarks and growth quantities (time frame: August 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03514563, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.