Impact of Temporomandibular Joint Dysfunction on Objective and Subjective Vocal Measures

NCT06046521 | Unknown

• 1 other identifier: MUDHF_PTT_03
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The present study aims to investigate the impact of temporomandibular joint dysfunction (TMD) on objective and subjective vocal parameters and the quality of life in affected patients. TMD is a pervasive public health issue that impacts approximately 25% of the general population and is notably more prevalent among women. The etiology of TMD is multi-factorial, with known risk factors such as parafunctional habits, emotional stress, occlusion issues, and orthodontic treatments. Internal derangements of the temporomandibular joint are the most common subtype of TMD, characterized by symptoms such as pain, joint noises, restricted mouth opening, and masticatory dysfunction. This study particularly focuses on the limitations in mouth opening due to TMD and its effects on vocal characteristics and quality of life. Conservative treatment methods, such as non-steroidal anti-inflammatory drugs (NSAIDs) and occlusal splints, have been effective in symptom management unless there is clear evidence of joint collapse or ankylosis. The null hypothesis (H0) posits that the restriction in mouth opening has no impact on vocal parameters or quality of life.

Conditions

Temporomandibular Joint Disorders; Voice Change

Outcome Measures

Primary Outcomes (5)

• Change in Acoustic Voice Analyze measurements (Analysis of dysphonia in speech and voice)

  Analysis of dysphonia in speech and voice (ADSV), asseses frequency domain parameters. It is based on 2 different vowels ((/a/ and /i/) from Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) and 6 different sentences. Each sentence includes a separate voice analysis, such as whether it has all the vowels, if it makes glottal attack sounds or not, nasal sounds or explosive sounds.

  T0: before occlusal splint treatment, T1: 1 month later occlusal splint treatment T2: 3 month later occlusal splint treatment T3: 6 months later occlusal splint treatment.

• Change in Acoustic Voice Analyze measurements (Motor Speech Profile)

  Motor Speech Profile (MSP), is utilized to ensure that speech is produced with accuracy and precision. Oral-diadochokinetic performance that is unreliable, inconsistent, or aberrant may be a sign of problems with the central nervous system or with peripheral sensory-motor processes. The software is built on a variety of protocols that offer various motor speech patterns, including oral diadochokinetic (DDK) rate, second formant transition rate, and syllable rate.

  T0: before occlusal splint treatment, T1: 1 month later occlusal splint treatment T2: 3 month later occlusal splint treatment T3: 6 months later occlusal splint treatment.

• Change in Acoustic Voice Analyze measurements (Acoustic Voice Quality Index)

  Acoustic Voice Quality Index (AVQI, evaluates the voice signal's perceived quality. It is based on assessing a number of acoustic factors that are known to be connected to how well speech is received. These criteria include assessments of the signal's loudness, pitch, and spectral tilt as well as its level of noise and other aberrations.

  T0: before occlusal splint treatment, T1: 1 month later occlusal splint treatment T2: 3 month later occlusal splint treatment T3: 6 months later occlusal splint treatment.

• Change in Acoustic Voice Analyze measurements (Acoustic Phonetic Analyzes)

  Acoustic Phonetic Analyzes, voiced, non-voiced, bursting, fricative sounds are being consisted differently. Periodic glottal vibrations make a sound voiced. Non-voiced ones is produced with burs or frication. Voice on-set time measures glottal vibrations and periods. 12 words which include 4 vowels and 6 consonants will analyze via Praat. Spectrum analyzes of the fricative consonants will be done with spectral moments.

  T0: before occlusal splint treatment, T1: 1 month later occlusal splint treatment T2: 3 month later occlusal splint treatment T3: 6 months later occlusal splint treatment.

• Change in Acoustic Voice Analyze measurements (Resonance Analyzes)

  For the analyze the resonance disturbances, nasometer is being used and the scores calculate with a special formula which include nasal and oral acoustic energies. Oral, nasal and oro-nasal paragraphs will be used for production.

  T0: before occlusal splint treatment, T1: 1 month later occlusal splint treatment T2: 3 month later occlusal splint treatment T3: 6 months later occlusal splint treatment.

Secondary Outcomes (12)

• Change in Oral Health Impact Profile-14 (OHIP-14):

  T0: before occlusal splint treatment, T1: 1 month later occlusal splint treatment T2: 3 month later occlusal splint treatment T3: 6 months later occlusal splint treatment.

• Influence of Clinical Case Report Changes (Painless unassisted mouth opening distance)

  T0: before occlusal splint treatment, T1: 1 month later occlusal splint treatment T2: 3 month later occlusal splint treatment T3: 6 months later occlusal splint treatment.

• Influence of Clinical Case Report Changes (Maximum unassisted mouth opening distance)

  T0: before occlusal splint treatment, T1: 1 month later occlusal splint treatment T2: 3 month later occlusal splint treatment T3: 6 months later occlusal splint treatment.

• Influence of Clinical Case Report Changes (Maximum assisted mouth opening distance)

  T0: before occlusal splint treatment, T1: 1 month later occlusal splint treatment T2: 3 month later occlusal splint treatment T3: 6 months later occlusal splint treatment.

• Influence of Clinical Case Report Changes (Vertical movement distances)

  T0: before occlusal splint treatment, T1: 1 month later occlusal splint treatment T2: 3 month later occlusal splint treatment T3: 6 months later occlusal splint treatment.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population comprises individuals aged between 18 and 65 who are fluent in the local language and capable of giving informed consent. Participants are screened to ensure they do not have a history of hearing impairment or high communicative demands in their profession. Moreover, individuals with a history of vocal disorders or any conditions that may affect voice quality are excluded from the study. The population also excludes pregnant or lactating women and individuals who are unable to provide informed consent or meet the study's specific requirements.

You may qualify if:

• Individuals aged between 18 and 65 years.
• Capable of giving informed consent.
• Fluent in the local language for effective communication.
• No history of hearing impairment or high communicative demands in their profession.
• Absence of a history of vocal disorders or conditions affecting voice quality.

You may not qualify if:

• Individuals with a vocal disorder.
• Unable to provide informed consent or meet study requirements.
• Pregnant or lactating women.
• Presence of any medical condition that could potentially affect voice quality.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University School of Dentistry

Istanbul, 34854, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Dysphonia

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: September 21, 2023
• Study Start: September 20, 2023
• Primary Completion: April 14, 2024
• Study Completion: June 14, 2024
• Last Updated: September 22, 2023

Record last verified: 2023-09

Locations

TU (1)