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RecruitingNCT04117360OSPUpdated Jun 12, 2026

Orthognathic Speech Pathology: Phonetic Contrasts of Patients With Dental Discrepancies Pre- and Post-Treatment Analyses

An observational study in Dentofacial Abnormalities, Dentofacial Deformities and Dentofacial Anomalies, Including Malocclusion, sponsored by University of North Carolina, Chapel Hill. Recruiting at 1 site in United States. Open to participants aged 15 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-06-12.

Sponsored by University of North Carolina, Chapel Hill · Observational

From the registry’s dates

  • Started Sep 2019; still recruiting 7 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
180
Ages
15 Years to 40 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dentofacial Abnormalities
  • Dentofacial Deformities
  • Dentofacial Anomalies, Including Malocclusion
  • Malocclusion
  • Malocclusion in Children
  • Dentofacial Disharmony
  • Skeletal Malocclusion
  • Skeletal Malformation
  • Speech Sound Disorder
  • Speech Disorders

Keywords

  • Dentofacial Disharmony
  • Skeletal malocclusion
  • Speech Sound Disorder
  • Spectral Moment Analysis
  • Tongue Ultrasound
  • Orthognathic Surgery
03

In context

Dentofacial Deformities

40 studies on the registry are indexed under Dentofacial Deformities; 16 are open to participants now.

This study's planned enrollment of 180 is above the median of 45 across 15 observational studies indexed under Dentofacial Deformities.

Browse Dentofacial Deformities studies →

Lead sponsor

University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.

Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population includes healthy patients who present in our oral surgery and/or orthodontic dentofacial disharmony clinics with skeletal underbites, open bites, and/or excessive overjet. These patients have decided (prior to our study) to pursue orthodontic treatment combined with orthognathic surgery to address their jaw disproportions.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Jaw surgery patient at UNC with a skeletal open bite, underbite or overjet greater than 5mm.
  • Age 15-40 years

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
180 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Other: Orthognathic surgery and Orthodontics

Interventions

  • OtherOrthognathic surgery and Orthodontics

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

06

What researchers measure

Primary outcomes

  1. Change in Speech Distortion Phonemes over Time

    Audio recordings of consonant phonemes will be quantitatively analyzed using spectral moment analysis yielding mean values.

    Time frame: pre-operation through 9-15 months post-operation

  2. Change in Quantitative Tongue Gestures over Time

    Ultrasound analysis of tongue posture to quantitatively describe tongue position during speech.

    Time frame: pre-operation through 9-15 months post-operation

07

Study locations

1 of 1 sites recruiting
  • University of North Carolina
    Chapel Hill, North Carolina 27514, United States
    Recruiting
    • Laura A Jacox, DMD, PhD, MS · ContactLJacox@ad.unc.edu · 847-702-0988
    • Laura A Jacox, DMD, PhD, MS · Principal investigator
08

References and documents

Individual participant data

Plan to share: No — Our data includes video, audio and ultrasound recordings. This is not data that can be shared and maintained confidentially while meeting HIPAA guidelines.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2019 (actual). Primary completion is estimated for Mar 2028, 102 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 3, 2019
First posted
Oct 7, 2019
StartActual
Sep 11, 2019
Primary completionEst.
Mar 2028
CompletionEst.
Mar 2028
Last update
Jun 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04117360
Collaborators
North Carolina State University
Responsible party
Sponsor
First posted
Oct 7, 2019
Start date
Sep 11, 2019
Primary completion
Mar 2028 (estimated)
Completion
Mar 2028 (estimated)
Last update
Jun 12, 2026

Study contacts

Laura A Jacox, PhD, DMD, MS
Contact
ljacox@ad.unc.edu
847- 702-0988
Sherrill T Phillips, BS
Contact
sherrill_phillips@unc.edu
Laura A Jacox, PhD, DMD, MS
principal investigator · Professor

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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