- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04117360
Orthognathic Speech Pathology: Phonetic Contrasts of Patients With Dental Discrepancies Pre- and Post-Treatment Analyses (OSP)
Orthognathic Speech Pathology: Phonetic Contrasts of Patients With Dentofacial Discrepancies With Pre- and Post-Treatment Analyses
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Purpose: The investigators are studying how phoneme distortion is effected by jaw disproportions in dentofacial disharmony (DFD) patients and whether speech improves after orthognathic surgery and orthodontic treatment. Spectral moment and tongue gestural analysis are being used to mechanistically determine how jaw position effects speech. The investigators hypothesize that skeletal open and underbites contribute to phoneme distortion and tongue gestural changes that improve following surgical correction of jaw position. All DFD patients are already seeking treatment from orthodontics and oral surgery. The study will observe how their speech changes before and after treatment. There is no randomization or intervention involved.
Aim 1: Qualify the prevalence of auditory and visual speech distortions in the DFD population. Aim 2: Quantitatively evaluate the first spectral moment (kHz) of four articulating consonant sounds (/t/, /k/, /s/, and /?/ pronounced "sh"). Quantify and analyze the changes in speech distortions for orthognathic patients pre and post-operation. Aim 3: Evaluate tongue posture during speech with patients from Aim 2 pre and post-operation.
Participants:
Participants: Patients of the UNC dentofacial disharmony (DFD) clinic who have undergone orthognathic surgery for correction of jaw disharmonies.
Procedures (methods):
Patients will be recorded pronouncing a series of words highlighting a range of phonetic contrasts including --/s-sh/ and t-k/. words each presented on a screen using PowerPoint, 3 times each with carrier phrases). Recordings include an acoustic feed, a profile video of the jaws plus lips, and ultrasound imaging of the tongue relative to the palate and jaws. Research staff will score audio recordings according to their spectral moments and ultrasound recordings according to tongue movement and associate findings with degree of dental discrepancy. Prospective recordings will be collected at three timepoints: 1-3 months prior to jaw surgery, 3-8 months and 9-15 months post-operation for 60 overbite, 60 openbite and 60 underbite DFD patients. These time points were selected to co-occur with patients' surgical check-ups to ensure reliable data collection while minimizing confounding factors such as severe facial swelling and splint placement which occur immediately after surgery.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Laura A Jacox, PhD, DMD, MS
- Phone Number: 847- 702-0988
- Email: ljacox@ad.unc.edu
Study Contact Backup
- Name: Sherrill T Phillips, BS
- Email: sherrill_phillips@unc.edu
Study Locations
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North Carolina
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Chapel Hill, North Carolina, United States, 27514
- Recruiting
- University of North Carolina
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Contact:
- Laura A Jacox, DMD, PhD, MS
- Phone Number: 847-702-0988
- Email: LJacox@ad.unc.edu
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Principal Investigator:
- Laura A Jacox, DMD, PhD, MS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Jaw surgery patient at UNC with a skeletal open bite, underbite or overjet greater than 5mm.
- Age 15-40 years
Exclusion Criteria:
- Hearing loss
- Learned English as a second language
- Significant regional accent, as characterized by a speech pathologist
- Developmental delay, performing several grade levels below age bracket
- history of craniofacial disorder
- genetic syndrome associated with known craniofacial presentation
- history of craniofacial trauma
- history of prior craniofacial surgery (excluding extractions and dental procedures)
- Jaw surgery without fixed orthodontic appliances
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Dentofacial Disharmony Patients
Dentofacial disharmony patients who are seeking jaw surgery in UNC oral and maxillofacial surgery department and are seen in UNC orthodontic dentofacial disharmony clinic.
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This study is observational.
All subjects identified to participate will be undergoing orthognathic jaw surgery and orthodontic treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Speech Distortion Phonemes over Time
Time Frame: pre-operation through 9-15 months post-operation
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Audio recordings of consonant phonemes will be quantitatively analyzed using spectral moment analysis yielding mean values.
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pre-operation through 9-15 months post-operation
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Change in Quantitative Tongue Gestures over Time
Time Frame: pre-operation through 9-15 months post-operation
|
Ultrasound analysis of tongue posture to quantitatively describe tongue position during speech.
|
pre-operation through 9-15 months post-operation
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Laura A Jacox, PhD, DMD, MS, professor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Congenital Abnormalities
- Musculoskeletal Diseases
- Stomatognathic Diseases
- Tooth Diseases
- Neurodevelopmental Disorders
- Stomatognathic System Abnormalities
- Maxillofacial Abnormalities
- Craniofacial Abnormalities
- Musculoskeletal Abnormalities
- Language Disorders
- Communication Disorders
- Malocclusion
- Speech Disorders
- Speech Sound Disorder
- Dentofacial Deformities
Other Study ID Numbers
- 19-1196
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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