Computational Modeling for Prediction of Acoustic Changes in Vowel Production Due to Orthognathic Surgery (PUMA)

Study Description

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Brief 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. 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.

Condition or disease	Intervention/treatment	Phase
Jaw Deformity; Facial Asymmetry	Other: MRI examination	Not Applicable

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

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	20 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Official Title:	Computational Modeling for Prediction of Acoustic Changes in Vowel Production
Study Start Date :	March 2012
Estimated Primary Completion Date :	December 2013
Estimated Study Completion Date :	December 2014

Arms and Interventions

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Arm

Intervention/treatment

Experimental: Computational modeling

Other: MRI examination; 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.; Other Name: with Siemens Avanto 1.5T MRI machine

Outcome Measures

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Primary Outcome Measures :

1. Acoustic changes in vowel production of hte patients duoe to orthognathic surgery [ Time Frame: 6 and 30 weeks postoperatively ]
   a measurement of sound formants

Secondary Outcome Measures :

1. Anatomical changes in vocal tract due to orthognathic surgery [ Time Frame: 6 and 30 weeks postoperatively ]
   changes in vocal track dimensions

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 50 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

- Healthy patients undergoing orthognathic surgery

Exclusion Criteria:

• 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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Finland
Turku University Hospital	Recruiting
Turku, Finland, F!-20521 Turku
Contact: Risto P Happonen, Professor +358-50-4121477 risto-pekka.happonen@tyks.fi

Sponsors and Collaborators

Turku University Hospital

Investigators

Principal Investigator:	Risto P Happonen, Professor	Turku University Hospital, Po. Box 52, FI-20521 Turku, Finland

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Turku University Hospital
ClinicalTrials.gov Identifier:	NCT01887977 History of Changes
Other Study ID Numbers:	T17/2012
First Posted:	June 27, 2013
Last Update Posted:	June 27, 2013
Last Verified:	June 2013

Keywords provided by Turku University Hospital:

Orthognathic surgery; Speech production; MRI

Additional relevant MeSH terms:

Facial Asymmetry; Jaw Abnormalities; Pathological Conditions, Anatomical; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities	Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities