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临床试验/NCT06046521
NCT06046521招募中不适用

A Clinical Study on the Effects of Temporomandibular Joint Dysfunction-Induced Limitations in Mouth Opening on Objective and Subjective Vocal Measurements

Marmara University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Change in Acoustic Voice Analyze measurements (Acoustic Voice Quality Index)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 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.

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.

Change in Acoustic Voice Analyze measurements (Resonance Analyzes)

时间窗: 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.

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.

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

时间窗: 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.

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.

Change in Acoustic Voice Analyze measurements (Motor Speech Profile)

时间窗: 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.

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.

Change in Acoustic Voice Analyze measurements (Acoustic Phonetic Analyzes)

时间窗: 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.

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.

次要结局

  • 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 (Eccentric 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.)
  • Influence of Clinical Case Report Changes (Way of movement)(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 (Sounds of articulate)(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 (Pain scores after palpations of the TMJ and muscles of mastication)(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 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 (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.)
  • Influence of Clinical Case Report Changes (Right and left movement)(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 (Protrusion)(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 (Midline deviation)(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.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ferit Bayram

Principal Investigator

Marmara University

研究点 (1)

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