Impact of Temporomandibular Joint Dysfunction on Objective and Subjective Vocal Measures

Temporomandibular Joint Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06046521
• Other study ID #: MUDHF_PTT_03
• Status: Recruiting
• Start date: September 20, 2023
• Est. completion date: June 14, 2024

Study information

• Verified date: September 2023
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 14, 2024
• Est. primary completion date: April 14, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Joint Diseases
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Locations

Country	Name	City	State
Turkey	Marmara University School of Dentistry	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	Change in Oral Health Impact Profile-14 (OHIP-14):	Oral health related life quality is an individual's self perception of how his/her oral health influences his/her life quality. OHIP basically has 14 questions that can be categorized into scales as functional limitation, physical pain, psychological discomfort, physical, psychological and social insufficiency and handicap.	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	Influence of Clinical Case Report Changes (Painless unassisted mouth opening distance)	Painless unassisted mouth opening distance, patient will be asked open mouth freely and painless and then will be measured interincisal distance with using millimetric ruler and add overbite 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.
Secondary	Influence of Clinical Case Report Changes (Maximum unassisted mouth opening distance)	Maximum unassisted mouth opening distance, patient will be asked to open mouth as much as possible. At that point, will questioned about feeling pain and if answer is yes where to feel. Muscle or junction, unilateral or bilateral pain situation will be saved. Finally overbite distance will be added.	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	Influence of Clinical Case Report Changes (Maximum assisted mouth opening distance)	Maximum assisted mouth opening distance, after completed maximum unassisted mouth opening, thumb will be placed on maxillary incisal teeth and index finger on mandibular incisal teeth and will try to open the patient's mouth and saved with adding overbite 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.
Secondary	Influence of Clinical Case Report Changes (Vertical movement distances)	Vertical movement distances, at maximum intercuspal position, where the maxillary incisors cover the mandibular incisor is marked and distance to the incisal edge is saved as overbite. And at this position, distance between the maxillary and mandibulary incisors horizontally will be measured with the ruler and saved as overjet.	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	Influence of Clinical Case Report Changes (Way of movement)	Way of movement, patient will wait in a relax situation and open mouth as much as they can even if painful. While the mandible moves, observer will look at the deflection from the midline or at the last stage of opening deviation from the midline.	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	Influence of Clinical Case Report Changes (Eccentric movement distances)	Right and left lateral movement, while mouth slight open, at the maximum movement to the right side distance between the incisors will be measured with millimetric ruler and repeat the same movement for the left side.	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	Influence of Clinical Case Report Changes (Right and left movement)	Right and left lateral movement, while mouth slight open, at the maximum movement to the right side distance between the incisors will be measured with millimetric ruler and repeat the same movement for the left side.	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	Influence of Clinical Case Report Changes (Protrusion)	Protrusion, patient will be asked the open mouth slightly but wide enough to avoid inflict between incisors and move the mandible forward as much as possible. Space between the incisors will be measured.	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	Influence of Clinical Case Report Changes (Midline deviation)	Midline deviation, if the distance between the midline projections of the lower and upper jaws is more than 1 mm, the amount will be recorded along with the direction of shift.	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	Influence of Clinical Case Report Changes (Sounds of articulate)	Sounds of articulate, palpation bilaterally on the preauricular region will be done with two index finger and look at if there is a sound while patient opens and closes the mouth. If there is, what kind of sound is being heard will be specified between click, hard crepitation, soft crepitation, and no sound.	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	Influence of Clinical Case Report Changes (Pain scores after palpations of the TMJ and muscles of mastication)	Pain scores after palpations of the TMJ and muscles of mastication, palpation of muscles will be done while mouth is rest, there is a space between teeth and muscles are passive. Patient will be asked to feel any pain during palpation and score to mild, moderate, severe or none. And palpation of TMJ will be done through ear way and lateral side while patient opens and closes the mouth.	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.