Clinical trial NCT06046521: Impact of Temporomandibular Joint Dysfunction on Objective and Subjective Vocal Measures
Official title: A Clinical Study on the Effects of Temporomandibular Joint Dysfunction-Induced Limitations in Mouth Opening on Objective and Subjective Vocal Measurements
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Temporomandibular Joint Disorders
Voice Change
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Acoustic Voice Analyze measurements (Analysis of dysphonia in speech and voice)
timeFrame: 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.
measure: Change in Acoustic Voice Analyze measurements (Motor Speech Profile)
timeFrame: 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.
measure: Change in Acoustic Voice Analyze measurements (Acoustic Voice Quality Index)
timeFrame: 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.
measure: Change in Acoustic Voice Analyze measurements (Acoustic Phonetic Analyzes)
timeFrame: 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.
measure: Change in Acoustic Voice Analyze measurements (Resonance Analyzes)
timeFrame: 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:
measure: Change in Oral Health Impact Profile-14 (OHIP-14):
timeFrame: 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.
measure: Influence of Clinical Case Report Changes (Painless unassisted mouth opening distance)
timeFrame: 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.
measure: Influence of Clinical Case Report Changes (Maximum unassisted mouth opening distance)
timeFrame: 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.
measure: Influence of Clinical Case Report Changes (Maximum assisted mouth opening distance)
timeFrame: 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.
measure: Influence of Clinical Case Report Changes (Vertical movement distances)
timeFrame: 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.
measure: Influence of Clinical Case Report Changes (Way of movement)
timeFrame: 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.
measure: Influence of Clinical Case Report Changes (Eccentric movement distances)
timeFrame: 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.
measure: Influence of Clinical Case Report Changes (Right and left movement)
timeFrame: 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.
measure: Influence of Clinical Case Report Changes (Protrusion)
timeFrame: 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.
measure: Influence of Clinical Case Report Changes (Midline deviation)
timeFrame: 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.
measure: Influence of Clinical Case Report Changes (Sounds of articulate)
timeFrame: 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.
measure: Influence of Clinical Case Report Changes (Pain scores after palpations of the TMJ and muscles of mastication)
timeFrame: 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.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Dentistry
Study officials:
References: