Orthognathic Speech Pathology: Phonetic Contrasts of Patients With Dental Discrepancies Pre- and … (NCT04117360) | Clinical Trial Compass
RecruitingNot Applicable
Orthognathic Speech Pathology: Phonetic Contrasts of Patients With Dental Discrepancies Pre- and Post-Treatment Analyses
United States180 participantsStarted 2019-09-11
Plain-language 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.
Who can participate
Age range
15 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Speech Distortion Phonemes over Time
Timeframe: pre-operation through 9-15 months post-operation
2
Change in Quantitative Tongue Gestures over Time
Timeframe: pre-operation through 9-15 months post-operation