NCT04117360

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Sep 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress92%
Sep 2019Dec 2026

Study Start

First participant enrolled

September 11, 2019

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2019

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

7.2 years

First QC Date

October 3, 2019

Last Update Submit

May 22, 2025

Conditions

Keywords

Dentofacial DisharmonySkeletal malocclusionSpeech Sound DisorderSpectral Moment AnalysisTongue UltrasoundOrthognathic Surgery

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

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

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

Dentofacial Disharmony Patients

Eligibility Criteria

Age15 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

RECRUITING

MeSH Terms

Conditions

Dentofacial DeformitiesMalocclusionSpeech Sound DisorderSpeech Disorders

Interventions

Orthognathic SurgeryOrthodontics

Condition Hierarchy (Ancestors)

Maxillofacial AbnormalitiesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesMusculoskeletal DiseasesStomatognathic System AbnormalitiesStomatognathic DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesTooth DiseasesCommunication DisordersNeurodevelopmental DisordersMental DisordersLanguage DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgery, OralDentistry

Study Officials

  • Laura A Jacox, PhD, DMD, MS

    Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura A Jacox, PhD, DMD, MS

CONTACT

Sherrill T Phillips, BS

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2019

First Posted

October 7, 2019

Study Start

September 11, 2019

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

May 25, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Our data includes video, audio and ultrasound recordings. This is not data that can be shared and maintained confidentially while meeting HIPAA guidelines.

Locations