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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04117360
Other study ID # 19-1196
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 11, 2019
Est. completion date December 2026

Study information

Verified date February 2024
Source University of North Carolina, Chapel Hill
Contact Laura A Jacox, PhD, DMD, MS
Phone 847- 702-0988
Email ljacox@ad.unc.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators are studying how speech is effected by jaw and tooth position in jaw surgery patients. Eighty percent of our jaw surgery patients have speech pathologies, compared to five percent of the general population, but speech pathologists do not understand why. The investigators hypothesize that open bites and underbites prevent most patients from being able to pronounce words normally and surgical correction will lead to improvement in speech. Patients will be audio recorded speaking and patients' tongue gestures ultrasound recorded before and after their jaw surgeries to observe what changes occur in their speech and tongue movements.


Description:

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Study Design


Intervention

Other:
Orthognathic surgery and Orthodontics
This study is observational. All subjects identified to participate will be undergoing orthognathic jaw surgery and orthodontic treatment.

Locations

Country Name City State
United States University of North Carolina Chapel Hill North Carolina

Sponsors (2)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill North Carolina State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Speech Distortion Phonemes over Time Audio recordings of consonant phonemes will be quantitatively analyzed using spectral moment analysis yielding mean values. pre-operation through 9-15 months post-operation
Primary Change in Quantitative Tongue Gestures over Time Ultrasound analysis of tongue posture to quantitatively describe tongue position during speech. pre-operation through 9-15 months post-operation
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