Temporomandibular Joint DisordersNCT06046521
Impact of Temporomandibular Joint Dysfunction on Objective and Subjective Vocal Measures
An observational study of Temporomandibular Joint Disorders and Voice Change, run by Marmara University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Disorders, Voice Change
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2023to 14 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University School of Dentistry
Istanbul, 34854
Ferit Bayram, Ph. D., 2167775000, ferit.bayram@marmara.edu.tr
Ahmet Konrot
About this study
Official title: A Clinical Study on the Effects of Temporomandibular Joint Dysfunction-Induced Limitations in Mouth Opening on Objective and Subjective Vocal Measurements
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
- Medical subject headings
- Temporomandibular Joint Disorders, Dysphonia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 outcomes (12)
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start20 Sep 2023
- Primary completion14 Apr 2024 (estimated)
- Study completion14 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferit Bayram, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046521
- Sponsor's protocol ID
- MUDHF_PTT_03
- Status last verified
- Sep 2023
- First submitted
- 14 Sep 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Effects of Temporomandibular Joint Dysfunction-Induced Limitations in Mouth Opening on Objective and Subjective Vocal Measurements
- ClinicalTrials.gov ID
- NCT06046521
- Acronym / sponsor ID
- MUDHF_PTT_03
- Conditions
- Temporomandibular Joint Disorders, Voice Change
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 14 Apr 2024 (estimated)
- Study completion
- 14 Jun 2024 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Acoustic Voice Analyze measurements (Analysis of dysphonia in speech and voice)
Time frame: 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)
Time frame: 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 Voice Quality Index)
Time frame: 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 (Acoustic Phonetic Analyzes)
Time frame: 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.
Change in Acoustic Voice Analyze measurements (Resonance Analyzes)
Time frame: 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.
12 secondary outcomes
Change in Oral Health Impact Profile-14 (OHIP-14):
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marmara University School of Dentistry
Istanbul, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temporomandibular Joint Disorders and Voice Change, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Acoustic Voice Analyze measurements (Analysis of dysphonia in speech and voice) (time frame: 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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.