Jaw DeformityPUMANCT01887977
Computational Modeling for Prediction of Acoustic Changes in Vowel Production Due to Orthognathic Surgery
A study testing MRI examination in people with Jaw Deformity and Facial Asymmetry, run by Turku University Hospital at 1 site in Finland.
Trial summary
A computational model of human sound production based on high quality anatomic measurements and physical laws of sound propagation cannot be accomplished without a comprehensive data set including both 3D-images of the speaker's anatomy and the simultaneous recording of speech. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Jaw Deformity, Facial Asymmetry
- What is being tested?
- MRI examination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2012to Dec 2014
- Phase
- Interventional
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy patients undergoing orthognathic surgery
Who cannot join
- Patients with conditions in which MRI examination is contraindicated (e.g. pace maker)
- Patients who require several operations or segmented jaw surgery
- Patients with cognitive impairment
- Patients with numerous dental amalgam fillings that may cause artifacts in MR images
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Turku University Hospital
Turku, F!-20521 Turku
Risto P Happonen, Professor, +358-50-4121477, risto-pekka.happonen@tyks.fi
About this study
Official title: Computational Modeling for Prediction of Acoustic Changes in Vowel Production
A computational model of human sound production based on high quality anatomic measurements and physical laws of sound propagation cannot be accomplished without a comprehensive data set including both 3D-images of the speaker's anatomy and the simultaneous recording of speech. Since the computational model has separate models for the vocal folds and the vocal tract, patients undergoing an orthognathic surgery is an optimal test object for the model development. Vocal folds remain unchanged while substantial changes take place in the vocal tract. Moreover, since the aim of the research is to predict acoustic changes in speech due to operations in head neck area, the orthognathic patient group is par excellence an example of such a prediction problem. If the model can be shown to give valuable information pre-operationally, many other patient groups could benefit from the results.
Read the detailed description
Orthognathic surgery deals with the correction of abnormalities of the facial tissues. The underlying cause for abnormality may be present at birth or acquired during the life as the result of distorted growth or trauma. Orthodontic treatment alone is not adequate in many cases due to severity of the deformities. In a typical operation, the position of either one jaw (mandible or maxilla) or both jaws is surgically changed in relation to the skull base. The movement of the jaw position varies usually between 5-15 mm either to anterior or posterior direction. Such a considerable movement has a very profound effect on the shape and volume of vocal tract resulting detectable changes in acoustics. Although the surgery involves mandibular and maxillary bone, changes occur also in the position and shape of respective soft tissues and hyoid bone, as well. For this project, 20 adult patients (10 women and 10 men) undergoing orthognathic surgery will be enrolled. Exclusion criteria include diseases and conditions in which MRI examination is contraindicated (.e.g. pace maker), severe speech or hearing impairment, and other situations where the patient has difficulties with completing the tasks defined in the research protocol. Furthermore, patients to whom segmental surgery of the jaws will be performed in connection of orthognathic surgery are excluded. A specific pre-selection criterion for patients is the presence of numerous dental amalgam fillings that may cause artifacts in MR images.
- Conditions
- Jaw Deformity, Facial Asymmetry
- Being tested
- MRI examination
- Keywords
- Orthognathic surgery, Speech production, MRI
- Medical subject headings
- Jaw Abnormalities, Facial Asymmetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI examinationOther
Also called with Siemens Avanto 1.5T MRI machine
The vocal and nasal tracts from the lips and nostrils to the beginning of the trachea are imaged with Siemens Avanto 1.5T MRI machine using carefully optimized, externally triggered imaging sequences that are synchronized with the rest of the experimental setting. A sound sample, given by the test subject, is recorded simultaneously to obtain a coupled data set: the speech sound and the precise anatomy which produces it.
| Study group | Role | What they receive |
|---|---|---|
| Computational modeling | Experimental | Not described Receives: Other: MRI examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acoustic changes in vowel production of hte patients duoe to orthognathic surgery
a measurement of sound formants
Measured: 6 and 30 weeks postoperatively
Secondary outcomes (1)
Anatomical changes in vocal tract due to orthognathic surgery
changes in vocal track dimensions
Measured: 6 and 30 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2013 (estimated)
- Study startMar 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jaw DeformityStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Risto P Happonen, Professor, Principal investigator, Turku University Hospital, Po. Box 52, FI-20521 Turku, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01887977
- Sponsor's protocol ID
- T17/2012
- Acronym
- PUMA
- Status last verified
- Jun 2013
- First submitted
- 28 Mar 2013
- Last updated
- 27 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computational Modeling for Prediction of Acoustic Changes in Vowel Production
- ClinicalTrials.gov ID
- NCT01887977
- Acronym / sponsor ID
- PUMA / T17/2012
- Conditions
- Jaw Deformity, Facial Asymmetry
- Keywords
- Orthognathic surgery, Speech production, MRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- Mar 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 27 Jun 2013 (estimated)
- 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.
A computational model of human sound production based on high quality anatomic measurements and physical laws of sound propagation cannot be accomplished without a comprehensive data set including both 3D-images of the speaker's anatomy and the simultaneous recording of speech. Since the computational model has separate models for the vocal folds and the vocal tract, patients undergoing an orthognathic surgery is an optimal test object for the model development. Vocal folds remain unchanged while substantial changes take place in the vocal tract. Moreover, since the aim of the research is to predict acoustic changes in speech due to operations in head neck area, the orthognathic patient group is par excellence an example of such a prediction problem. If the model can be shown to give valuable information pre-operationally, many other patient groups could benefit from the results.
Detailed description
Orthognathic surgery deals with the correction of abnormalities of the facial tissues. The underlying cause for abnormality may be present at birth or acquired during the life as the result of distorted growth or trauma. Orthodontic treatment alone is not adequate in many cases due to severity of the deformities. In a typical operation, the position of either one jaw (mandible or maxilla) or both jaws is surgically changed in relation to the skull base. The movement of the jaw position varies usually between 5-15 mm either to anterior or posterior direction. Such a considerable movement has a very profound effect on the shape and volume of vocal tract resulting detectable changes in acoustics. Although the surgery involves mandibular and maxillary bone, changes occur also in the position and shape of respective soft tissues and hyoid bone, as well. For this project, 20 adult patients (10 women and 10 men) undergoing orthognathic surgery will be enrolled. Exclusion criteria include diseases and conditions in which MRI examination is contraindicated (.e.g. pace maker), severe speech or hearing impairment, and other situations where the patient has difficulties with completing the tasks defined in the research protocol. Furthermore, patients to whom segmental surgery of the jaws will be performed in connection of orthognathic surgery are excluded. A specific pre-selection criterion for patients is the presence of numerous dental amalgam fillings that may cause artifacts in MR images.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Computational modeling | Experimental | Other: MRI examination |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy patients undergoing orthognathic surgery
Key exclusion criteria (4 listed)
- Patients with conditions in which MRI examination is contraindicated (e.g. pace maker)
- Patients who require several operations or segmented jaw surgery
- Patients with cognitive impairment
- Patients with numerous dental amalgam fillings that may cause artifacts in MR images
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 examinationAlso: with Siemens Avanto 1.5T MRI machineThe vocal and nasal tracts from the lips and nostrils to the beginning of the trachea are imaged with Siemens Avanto 1.5T MRI machine using carefully optimized, externally triggered imaging sequences that are synchronized with the rest of the experimental setting. A sound sample, given by the test subject, is recorded simultaneously to obtain a coupled data set: the speech sound and the precise anatomy which produces it. | Other | Computational modeling |
Primary outcome
Acoustic changes in vowel production of hte patients duoe to orthognathic surgery
Time frame: 6 and 30 weeks postoperatively
a measurement of sound formants
1 secondary outcome
Anatomical changes in vocal tract due to orthognathic surgery
Time frame: 6 and 30 weeks postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2013.
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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.
Risto P Happonen, Professor principal investigator
Turku University Hospital, Po. Box 52, FI-20521 Turku, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI examination in people with Jaw Deformity and Facial Asymmetry, run by Turku University Hospital at 1 site in Finland.
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 4 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: status not confirmed, as of the sponsor's last update on 27 Jun 2013. 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 Finland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acoustic changes in vowel production of hte patients duoe to orthognathic surgery (time frame: 6 and 30 weeks postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2013.