BruxismBruxismNCT07560670
Determining the Relationship Between Posture, Muscle Stiffness, Pain, and Jaw Functionality in Individuals With Bruxism
An observational study of Bruxism and Posture, run by Istanbul Kent University at 1 site in Turkey (Türkiye).
Trial summary
Bruxism is a repetitive jaw-muscle activity characterized by teeth clenching and/or grinding, often associated with temporomandibular joint dysfunction, pain, and impaired jaw function. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Bruxism, Posture, Sleep Quality
- What is being tested?
- Bruxism Assessment Form, Clinical Examination and Patient Evaluation Form
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2025to 15 Apr 2026
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: In the literature, a moderate correlation has been found between the jaw functional limitation scale and pain level in temporomandibular joint dysfunction (r=0.3-0.4). Based on the results of the relevant study, G-power analysis was used to calculate the sample size. The expected effect size for our study was considered moderate at 80% power and an alpha value of 0.05 (effect size=0.4), and we planned to include 24 bruxism patients and 24 healthy individuals.
Who may be able to join
- Individuals diagnosed with bruxism following a physical examination and assessment questionnaire administered by a specialist dentist were included in the study.
- Being between the ages of 18 and 30
- Having jaw pain that has persisted for at least 3 months
- Patients who described pain in the face, temporal region, or ear, and who had pain detected in the masticatory muscles upon palpation.
- Volunteering to participate in the study
- Cooperative individuals with whom mutual communication is possible
- Literate
Who cannot join
- History of surgery or trauma to the maxillofacial region
- Active infection in the maxillofacial region
- Presence of cysts, tumors, or malignant pathologies affecting the TMJ region and muscles
- Presence of systemic rheumatic disease or musculoskeletal diseases affecting the bones
- Presence of any neurological problem that would preclude evaluations
- Diagnosis of any psychiatric disorder
- Receiving physiotherapy or other treatment methods for the TMJ or cervical spinal region within the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining the Relationship Between Posture, Muscle Stiffness, Pain, and Jaw Functionality in Individuals With Bruxism: A Comparative Cross-Sectional Study
Bruxism is a repetitive jaw-muscle activity characterized by teeth clenching and/or grinding, often associated with temporomandibular joint dysfunction, pain, and impaired jaw function. This cross-sectional comparative study aims to investigate the relationship between jaw functionality, posture, muscle stiffness, pain, perceived stress, and sleep quality in young adults with bruxism. A total of 48 participants will be included: 24 individuals with clinically confirmed bruxism and 24 healthy controls.
Clinical and sociodemographic characteristics will be recorded using a Bruxism Assessment Form developed by dentists and physiotherapists. Posture will be assessed with the PostureScreen Mobile® application; pain intensity and thresholds will be measured using a digital algometer; masseter, temporalis, and trapezius muscle stiffness will be evaluated with a MyotonPro device. Perceived stress will be assessed using the Perceived Stress Scale-10, sleep quality with the Epworth Sleepiness Scale, and functional jaw limitation with the Jaw Functional Limitation Scale-20.
Read more
Statistical analysis will be performed using SPSS (Version 20.0). Between-group comparisons will be made using t-tests or Mann-Whitney U tests depending on distribution. Correlation analyses (Pearson or Spearman) will be used to evaluate associations among variables.
The primary outcome is to determine the relationship between jaw functionality, posture, muscle stiffness, and pain in individuals with bruxism. Secondary outcomes include the associations of sleep quality and perceived stress with these parameters. This study will provide novel insights into the multidimensional impact of bruxism and may guide future preventive and rehabilitative strategies.
Read the detailed description
Bruxism is a repetitive jaw-muscle activity, characterized by teeth clenching or grinding, that may occur during sleep or wakefulness. It is associated with temporomandibular disorders, increased muscle activity, pain, impaired jaw function, and reduced quality of life. Although bruxism has been linked to psychological factors such as stress and sleep disturbances, the relationship between jaw functionality, posture, muscle stiffness, and pain remains unclear.
This cross-sectional comparative study will include 48 young adults, consisting of 24 individuals with clinically confirmed bruxism and 24 age-matched healthy controls. Participants will undergo a comprehensive evaluation process. Bruxism will be confirmed by a dental specialist through clinical examination combined with a standardized Bruxism Assessment Questionnaire. Clinical and sociodemographic data will be collected with a patient assessment form.
Outcome measures will include:
Posture assessment: PostureScreen Mobile® application, using standardized digital imaging.
Pain assessment: Pain intensity and thresholds measured with a digital algometer on masseter, temporalis, trapezius muscles, and temporomandibular joint regions.
Muscle stiffness: Quantified with the MyotonPro device on jaw and neck muscles.
Perceived stress: Evaluated using the Perceived Stress Scale-10.
Sleep quality: Assessed with the Epworth Sleepiness Scale.
Jaw functionality: Evaluated with the Jaw Functional Limitation Scale-20.
Data will be analyzed with SPSS (Version 20.0). Normality will be tested with Shapiro-Wilk. Depending on distribution, parametric or non-parametric tests (Independent Samples t-test, Mann-Whitney U test) will be applied for between-group comparisons. Correlation analyses (Pearson or Spearman) will explore associations among variables. A significance level of p<0.05 will be adopted.
The primary objective is to determine the relationship between jaw functionality, posture, muscle stiffness, and pain in individuals with bruxism. The secondary objective is to examine the impact of perceived stress and sleep quality on these parameters and to compare findings with a healthy control group.
This study is expected to fill a gap in the literature by providing evidence on the multifactorial associations between bruxism, postural control, muscle characteristics, and psychosocial factors. Findings may contribute to the development of multidisciplinary preventive and therapeutic strategies in dentistry, physiotherapy, and rehabilitation.
- Conditions
- Bruxism, Posture, Sleep Quality, Pain Assessment, Muscle Stiffness
- Being tested
- Bruxism Assessment Form, Clinical Examination, Patient Evaluation Form, Perceived Stress Scale-10, Posture Assessment
- Keywords
- Temporomandibular Joint Disorders, Jaw Function, Posture, Bruxism, Muscle Stiffness, MyotonPro, Pain Threshold, Algometry, Perceived Stress, Sleep Quality, Epworth Sleepiness Scale, Jaw Functional Limitation Scale (JFLS-20), PostureScreen Mobile, Young Adults, Comparative Cross-Sectional Study
- Medical subject headings
- Bruxism, Sleep Initiation and Maintenance Disorders, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bruxism Assessment FormOther
Also called Bruxism Assessment Questionnaire
To determine the presence of bruxism, the Bruxism Assessment Questionnaire, adapted from internationally accepted scales, will be administered. The questionnaire includes seven questions regarding both sleep and daytime bruxism. The questions were developed based on similar studies. Based on their responses, participants will be classified as having a low, moderate, or high risk of bruxism.
Clinical ExaminationOther
Participants will undergo a detailed clinical examination by a dentist to diagnose bruxism. The clinical evaluation will be based on the following parameters: a dental examination, a muscle examination, and a jaw joint examination.
The dental examination will assess tooth wear, cervical wear, scalloping at the edge of the tongue, the presence of linea alba in the buccal mucosa, and palpation of the masseter, temporalis, and suprahyoid muscles.
The jaw joint examination will assess the diagnosis and severity of bruxism by combining mouth opening, clicking or crepitation in the jaw joint, clinical examination findings, and questionnaire scores. Based on the questionnaire and clinical examination results, participants will be divided into three groups: "Probable no bruxism," "Possible bruxism," and "Definite bruxism." A healthy group (n=24) will be formed from the "Probable no bruxism" group, and a patient group (n=24) will be formed from the "Definite bruxism" group.
Patient Evaluation FormOther
The patient evaluation form, developed by the researchers, will be evaluated in detail by the Specialist Dentist after the diagnosis is made. The patient will include the clinical characteristics of the disease, the patient's sociodemographic characteristics, the presence of a chronic or systemic disease, any medications used, the presence of deflection or deviation during mandibular depression, joint noise, the presence of trigger points in the masseter and temporal regions, jaw pain intensity using the Visual Analog Scale (upon waking, during eating, after eating, at bedtime, and temporal headache), and mandibular joint range of motion (painless, maximal, maximal assisted, right lateral and left lateral flexion, and protrusion) using a 10-cm ruler and digital calipers.
Perceived Stress Scale-10Other
Also called Perceived Stress Scale
The Perceived Stress Scale-10 (PSS-10) questionnaire will be used to assess stress levels. The PSS-10 was developed by Cohen, Kamarck, and Mermelstein (1983). The PSS-10 is a 10-item self-report instrument designed to measure how unpredictable, uncontrollable, and stressful participants perceive their lives to be in the past month. Participants rate each item on a 5-point Likert-type scale ranging from "Never (0)" to "Very often (4)." Total scores range from 0 to 40, with higher scores indicating higher perceived stress levels. Items 6, 7, 9, and 10 are reverse-scored. Its validity and reliability in Turkish were conducted by Eskin et al.
Posture AssessmentOther
Also called Posture
The PostureScreen Mobile® app will be used to assess posture in a standing position. This app is specifically designed for healthcare professionals who want to objectively assess patients' posture, movement, and body composition. The app calculates a total of thirty-nine variables using images taken from four different angles. It generates an output file containing the calculated values for posture variables and provides visuals showing the positions of the digitized points relative to normal posture. For the posture assessment, participants will be positioned at a designated marked point and asked to stand in a comfortable, neutral posture. Photographs of each participant will be taken from four different angles using the iPad camera. Researchers will take each photo from a distance of 8 feet (approximately 2.4 meters) from the participant. The camera height is not standardized and will be adjusted according to the participant's height.
Muscle Stiffness AssessmentOther
Muscle stiffness will be assessed using the Myoton Digital Muscle Palpation Device in the masseter, upper trapezius, and temporalis muscles.
The Epworth Sleepiness Scale (ESS)Other
Also called The Epworth Sleepiness Scale
The Epworth Sleepiness Scale (ESS) was developed by Johns and will be used to assess sleepiness in patients. The ESS is a four-point Likert-type scale. It is scored as 0, 1, 2, or 3, with higher scores indicating increased sleepiness. A score of 0-5 indicates normal daytime sleepiness, 6-10 indicates normal but increased daytime sleepiness, 11-12 indicates increased but moderate daytime sleepiness, 13-15 indicates increased moderate daytime sleepiness, and 16-24 indicates increased severe daytime sleepiness. The ESS is a valid and reliable scale for assessing overall sleepiness levels and can be used in studies on sleep and sleep disorders in Turkey (Cronbach's alpha = 0.86).
Jaw Function Limitation Scale-20 (MFFS-20)Other
The MFFS-20 questionnaire will be used to measure jaw function and limitations during various activities. The scale includes 20 items in the areas of chewing, vertical jaw mobility, and verbal and emotional expression. Items 1-6 address chewing, items 7-10 address vertical jaw mobility, and items 11-20 address verbal and emotional expression of limitations. Patients will be assessed for their limitations on each item using a numerical rating scale of 0 to 10. "0" corresponds to no limitation, and "10" corresponds to severe limitation.
Pain threshold assessmentOther
Participants' pain sensitivity to pressure will be assessed using an algometer. A digital algometer (Commender Jtech Medical 801-478 USA) will be used for the assessment. The algometer will measure three times on the body of the masseter muscle, the anterior part of the temporalis muscle, the upper trapezius muscle, and the temporomandibular joint. The algometer will be placed perpendicular to these points, and participants will be asked to report the first time they experience pain. The average of the readings on the display will be read, and the pain threshold will be recorded in pounds (1kg = 2.2 pounds).
| Study group | Role | What they receive |
|---|---|---|
| Bruxism | 24 patients diagnosed with bruxism will be included. Receives: Other: Bruxism Assessment Form; Other: Clinical Examination; Other: Patient Evaluation Form; Other: Perceived Stress Scale-10; Other: Posture Assessment; Other: Muscle Stiffness Assessment; Other: The Epworth Sleepiness Scale (ESS); Other: Jaw Function Limitation Scale-20 (MFFS-20); Other: Pain threshold assessment | |
| Healthy | 24 healthy individuals will be included Receives: Other: Bruxism Assessment Form; Other: Clinical Examination; Other: Patient Evaluation Form; Other: Perceived Stress Scale-10; Other: Posture Assessment; Other: Muscle Stiffness Assessment; Other: The Epworth Sleepiness Scale (ESS); Other: Jaw Function Limitation Scale-20 (MFFS-20); Other: Pain threshold assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Jaw Functional Limitation Total Score Assessed Using the 20-Item Jaw Functional Limitation Scale (JFLS-20)
Jaw functional limitation will be assessed using the 20-Item Jaw Functional Limitation Scale (JFLS-20). The outcome measure will be the total JFLS-20 score, ranging from 0 to 10 (mean global score; 0 = no limitation, 10 = severe limitation). Higher scores indicate greater jaw functional limitation (worse outcome).
Measured: At baseline (study enrollment)
Pain Intensity and Pain Threshold
Pain intensity will be assessed using the Visual Analog Scale (VAS), recorded as a score on a 0-10 cm (veya 0-100 mm, hangisini kullanıyorsanız) scale, with higher scores indicating greater pain intensity.Pressure pain threshold will be assessed using a digital algometer and recorded as pressure values (kg/cm², N/cm², ya da kullandığınız birim ne ise onu yazın), with higher values indicating higher pain threshold.
Measured: At baseline
Postural Alignment Parameters Assessed Using the PostureScreen Mobile® Application
Postural alignment parameters, including head position, shoulder alignment, spinal posture, and pelvic alignment (uygun olanları siz düzenleyin), will be quantitatively assessed using the PostureScreen Mobile® application.
Measured: At baseline
Muscle Stiffness (N/m) of the Masseter, Temporalis, and Trapezius Muscles Assessed Using the MyotonPRO Device
Muscle stiffness will be quantitatively assessed in the masseter, temporalis, and trapezius muscles using the MyotonPRO handheld myotonometer. Stiffness will be recorded in Newtons per meter (N/m) as the primary biomechanical parameter used for evaluation.
Measured: At baseline
Secondary outcomes (2)
Sleep Quality
Daytime sleepiness will be assessed using the Epworth Sleepiness Scale (ESS). The outcome measure will be the total ESS score (range 0-24), with higher scores indicating greater daytime sleepiness.
Measured: At baseline
Perceived Stress
Perceived Stress Scale-10 (PSS-10) score
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start15 Oct 2025
- Primary completion30 Nov 2025
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BruxismStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Kent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Nur Demircan, Istanbul Kent University
- Investigators
- Emine Nur Demircan, Asst. Prof., Principal investigator, Istanbul Kent UniversityBerfin Erdemli, Res. Asst., Study director, Istanbul Kent UniversityMelis Usul, Res. Asst., Study director, Istanbul Kent UniversityOzge Okcu, Asst. Prof., Study director, Istanbul Kent UniversityFatma Yüce, Asst. Prof., Study director, Istanbul Kent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07560670
- Sponsor's protocol ID
- IstanbulKentU
- Other IDs
- IstanbulKentU
- Acronym
- Bruxism
- Status last verified
- Apr 2026
- First submitted
- 27 Sep 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Izci B, Ardic S, Firat H, Sahin A, Altinors M, Karacan I. Reliability and validity studies of the Turkish version of the Epworth Sleepiness Scale. Sleep Breath. 2008 May;12(2):161-8. doi: 10.1007/s11325-007-0145-7.
PubMed 17922157Szucs KA, Brown EVD. Rater reliability and construct validity of a mobile application for posture analysis. J Phys Ther Sci. 2018 Jan;30(1):31-36. doi: 10.1589/jpts.30.31. Epub 2018 Jan 27.
PubMed 29410561Xiong X, Xiao CQ, Yang YC, Li YJ, Cheng QY, Wang XY, Liu Y. Temporomandibular disorder patients with excessive daytime sleepiness present greater pain intensity and reduced jaw function. J Oral Rehabil. 2024 Apr;51(4):639-647. doi: 10.1111/joor.13639. Epub 2023 Dec 15.
PubMed 38100233
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Relationship Between Posture, Muscle Stiffness, Pain, and Jaw Functionality in Individuals With Bruxism: A Comparative Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07560670
- Acronym / sponsor ID
- Bruxism / IstanbulKentU
- Conditions
- Bruxism, Posture, Sleep Quality, Pain Assessment, Muscle Stiffness
- Keywords
- Temporomandibular Joint Disorders, Jaw Function, Posture, Bruxism, Muscle Stiffness, MyotonPro, Pain Threshold, Algometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istanbul Kent UniversityUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 1 May 2026 (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.
Bruxism is a repetitive jaw-muscle activity characterized by teeth clenching and/or grinding, often associated with temporomandibular joint dysfunction, pain, and impaired jaw function. This cross-sectional comparative study aims to investigate the relationship between jaw functionality, posture, muscle stiffness, pain, perceived stress, and sleep quality in young adults with bruxism. A total of 48 participants will be included: 24 individuals with clinically confirmed bruxism and 24 healthy controls.
Clinical and sociodemographic characteristics will be recorded using a Bruxism Assessment Form developed by dentists and physiotherapists. Posture will be assessed with the PostureScreen Mobile® application; pain intensity and thresholds will be measured using a digital algometer; masseter, temporalis, and trapezius muscle stiffness will be evaluated with a MyotonPro device. Perceived stress will be assessed using the Perceived Stress Scale-10, sleep quality with the Epworth Sleepiness Scale, and functional jaw limitation with the Jaw Functional Limitation Scale-20.
Statistical analysis will be performed using SPSS (Version 20.0). Between-group comparisons will be made using t-tests or Mann-Whitney U tests depending on distribution. Correlation analyses (Pearson or Spearman) will be used to evaluate associations among variables.
The primary outcome is to determine the relationship between jaw functionality, posture, muscle stiffness, and pain in individuals with bruxism. Secondary outcomes include the associations of sleep quality and perceived stress with these parameters. This study will provide novel insights into the multidimensional impact of bruxism and may guide future preventive and rehabilitative strategies.
Detailed description
Bruxism is a repetitive jaw-muscle activity, characterized by teeth clenching or grinding, that may occur during sleep or wakefulness. It is associated with temporomandibular disorders, increased muscle activity, pain, impaired jaw function, and reduced quality of life. Although bruxism has been linked to psychological factors such as stress and sleep disturbances, the relationship between jaw functionality, posture, muscle stiffness, and pain remains unclear.
This cross-sectional comparative study will include 48 young adults, consisting of 24 individuals with clinically confirmed bruxism and 24 age-matched healthy controls. Participants will undergo a comprehensive evaluation process. Bruxism will be confirmed by a dental specialist through clinical examination combined with a standardized Bruxism Assessment Questionnaire. Clinical and sociodemographic data will be collected with a patient assessment form.
Outcome measures will include:
Posture assessment: PostureScreen Mobile® application, using standardized digital imaging.
Pain assessment: Pain intensity and thresholds measured with a digital algometer on masseter, temporalis, trapezius muscles, and temporomandibular joint regions.
Muscle stiffness: Quantified with the MyotonPro device on jaw and neck muscles.
Perceived stress: Evaluated using the Perceived Stress Scale-10.
Sleep quality: Assessed with the Epworth Sleepiness Scale.
Jaw functionality: Evaluated with the Jaw Functional Limitation Scale-20.
Data will be analyzed with SPSS (Version 20.0). Normality will be tested with Shapiro-Wilk. Depending on distribution, parametric or non-parametric tests (Independent Samples t-test, Mann-Whitney U test) will be applied for between-group comparisons. Correlation analyses (Pearson or Spearman) will explore associations among variables. A significance level of p<0.05 will be adopted.
The primary objective is to determine the relationship between jaw functionality, posture, muscle stiffness, and pain in individuals with bruxism. The secondary objective is to examine the impact of perceived stress and sleep quality on these parameters and to compare findings with a healthy control group.
This study is expected to fill a gap in the literature by providing evidence on the multifactorial associations between bruxism, postural control, muscle characteristics, and psychosocial factors. Findings may contribute to the development of multidisciplinary preventive and therapeutic strategies in dentistry, physiotherapy, and rehabilitation.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bruxism | – | Other: Bruxism Assessment Form, Other: Clinical Examination, Other: Patient Evaluation Form, Other: Perceived Stress Scale-10, Other: Posture Assessment, Other: Muscle Stiffness Assessment, Other: The Epworth Sleepiness Scale (ESS), Other: Jaw Function Limitation Scale-20 (MFFS-20), Other: Pain threshold assessment24 patients diagnosed with bruxism will be included. |
| Healthy | – | Other: Bruxism Assessment Form, Other: Clinical Examination, Other: Patient Evaluation Form, Other: Perceived Stress Scale-10, Other: Posture Assessment, Other: Muscle Stiffness Assessment, Other: The Epworth Sleepiness Scale (ESS), Other: Jaw Function Limitation Scale-20 (MFFS-20), Other: Pain threshold assessment24 healthy individuals will be included |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- In the literature, a moderate correlation has been found between the jaw functional limitation scale and pain level in temporomandibular joint dysfunction (r=0.3-0.4). Based on the results of the relevant study, G-power analysis was used to calculate the sample size. The expected effect size for our study was considered moderate at 80% power and an alpha value of 0.05 (effect size=0.4), and we planned to include 24 bruxism patients and 24 healthy individuals.
Key inclusion criteria (7 listed)
- Individuals diagnosed with bruxism following a physical examination and assessment questionnaire administered by a specialist dentist were included in the study.
- Being between the ages of 18 and 30
- Having jaw pain that has persisted for at least 3 months
- Patients who described pain in the face, temporal region, or ear, and who had pain detected in the masticatory muscles upon palpation.
- Volunteering to participate in the study
Key exclusion criteria (7 listed)
- History of surgery or trauma to the maxillofacial region
- Active infection in the maxillofacial region
- Presence of cysts, tumors, or malignant pathologies affecting the TMJ region and muscles
- Presence of systemic rheumatic disease or musculoskeletal diseases affecting the bones
- Presence of any neurological problem that would preclude evaluations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bruxism Assessment FormAlso: Bruxism Assessment QuestionnaireTo determine the presence of bruxism, the Bruxism Assessment Questionnaire, adapted from internationally accepted scales, will be administered. The questionnaire includes seven questions regarding both sleep and daytime bruxism. The questions were developed based on similar studies. Based on their responses, participants will be classified as having a low, moderate, or high risk of bruxism. | Other | Bruxism, Healthy |
| Clinical ExaminationParticipants will undergo a detailed clinical examination by a dentist to diagnose bruxism. The clinical evaluation will be based on the following parameters: a dental examination, a muscle examination, and a jaw joint examination. The dental examination will assess tooth wear, cervical wear, scalloping at the edge of the tongue, the presence of linea alba in the buccal mucosa, and palpation of the masseter, temporalis, and suprahyoid muscles. The jaw joint examination will assess the diagnosis and severity of bruxism by combining mouth opening, clicking or crepitation in the jaw joint, clinical examination findings, and questionnaire scores. Based on the questionnaire and clinical examination results, participants will be divided into three groups: "Probable no bruxism," "Possible bruxism," and "Definite bruxism." A healthy group (n=24) will be formed from the "Probable no bruxism" group, and a patient group (n=24) will be formed from the "Definite bruxism" group. | Other | Bruxism, Healthy |
| Patient Evaluation FormThe patient evaluation form, developed by the researchers, will be evaluated in detail by the Specialist Dentist after the diagnosis is made. The patient will include the clinical characteristics of the disease, the patient's sociodemographic characteristics, the presence of a chronic or systemic disease, any medications used, the presence of deflection or deviation during mandibular depression, joint noise, the presence of trigger points in the masseter and temporal regions, jaw pain intensity using the Visual Analog Scale (upon waking, during eating, after eating, at bedtime, and temporal headache), and mandibular joint range of motion (painless, maximal, maximal assisted, right lateral and left lateral flexion, and protrusion) using a 10-cm ruler and digital calipers. | Other | Bruxism, Healthy |
| Perceived Stress Scale-10Also: Perceived Stress ScaleThe Perceived Stress Scale-10 (PSS-10) questionnaire will be used to assess stress levels. The PSS-10 was developed by Cohen, Kamarck, and Mermelstein (1983). The PSS-10 is a 10-item self-report instrument designed to measure how unpredictable, uncontrollable, and stressful participants perceive their lives to be in the past month. Participants rate each item on a 5-point Likert-type scale ranging from "Never (0)" to "Very often (4)." Total scores range from 0 to 40, with higher scores indicating higher perceived stress levels. Items 6, 7, 9, and 10 are reverse-scored. Its validity and reliability in Turkish were conducted by Eskin et al. | Other | Bruxism, Healthy |
| Posture AssessmentAlso: PostureThe PostureScreen Mobile® app will be used to assess posture in a standing position. This app is specifically designed for healthcare professionals who want to objectively assess patients' posture, movement, and body composition. The app calculates a total of thirty-nine variables using images taken from four different angles. It generates an output file containing the calculated values for posture variables and provides visuals showing the positions of the digitized points relative to normal posture. For the posture assessment, participants will be positioned at a designated marked point and asked to stand in a comfortable, neutral posture. Photographs of each participant will be taken from four different angles using the iPad camera. Researchers will take each photo from a distance of 8 feet (approximately 2.4 meters) from the participant. The camera height is not standardized and will be adjusted according to the participant's height. | Other | Bruxism, Healthy |
| Muscle Stiffness AssessmentMuscle stiffness will be assessed using the Myoton Digital Muscle Palpation Device in the masseter, upper trapezius, and temporalis muscles. | Other | Bruxism, Healthy |
| The Epworth Sleepiness Scale (ESS)Also: The Epworth Sleepiness ScaleThe Epworth Sleepiness Scale (ESS) was developed by Johns and will be used to assess sleepiness in patients. The ESS is a four-point Likert-type scale. It is scored as 0, 1, 2, or 3, with higher scores indicating increased sleepiness. A score of 0-5 indicates normal daytime sleepiness, 6-10 indicates normal but increased daytime sleepiness, 11-12 indicates increased but moderate daytime sleepiness, 13-15 indicates increased moderate daytime sleepiness, and 16-24 indicates increased severe daytime sleepiness. The ESS is a valid and reliable scale for assessing overall sleepiness levels and can be used in studies on sleep and sleep disorders in Turkey (Cronbach's alpha = 0.86). | Other | Bruxism, Healthy |
| Jaw Function Limitation Scale-20 (MFFS-20)The MFFS-20 questionnaire will be used to measure jaw function and limitations during various activities. The scale includes 20 items in the areas of chewing, vertical jaw mobility, and verbal and emotional expression. Items 1-6 address chewing, items 7-10 address vertical jaw mobility, and items 11-20 address verbal and emotional expression of limitations. Patients will be assessed for their limitations on each item using a numerical rating scale of 0 to 10. "0" corresponds to no limitation, and "10" corresponds to severe limitation. | Other | Bruxism, Healthy |
| Pain threshold assessmentParticipants' pain sensitivity to pressure will be assessed using an algometer. A digital algometer (Commender Jtech Medical 801-478 USA) will be used for the assessment. The algometer will measure three times on the body of the masseter muscle, the anterior part of the temporalis muscle, the upper trapezius muscle, and the temporomandibular joint. The algometer will be placed perpendicular to these points, and participants will be asked to report the first time they experience pain. The average of the readings on the display will be read, and the pain threshold will be recorded in pounds (1kg = 2.2 pounds). | Other | Bruxism, Healthy |
Primary outcome
Jaw Functional Limitation Total Score Assessed Using the 20-Item Jaw Functional Limitation Scale (JFLS-20)
Time frame: At baseline (study enrollment)
Jaw functional limitation will be assessed using the 20-Item Jaw Functional Limitation Scale (JFLS-20). The outcome measure will be the total JFLS-20 score, ranging from 0 to 10 (mean global score; 0 = no limitation, 10 = severe limitation). Higher scores indicate greater jaw functional limitation (worse outcome).
Pain Intensity and Pain Threshold
Time frame: At baseline
Pain intensity will be assessed using the Visual Analog Scale (VAS), recorded as a score on a 0-10 cm (veya 0-100 mm, hangisini kullanıyorsanız) scale, with higher scores indicating greater pain intensity.Pressure pain threshold will be assessed using a digital algometer and recorded as pressure values (kg/cm², N/cm², ya da kullandığınız birim ne ise onu yazın), with higher values indicating higher pain threshold.
Postural Alignment Parameters Assessed Using the PostureScreen Mobile® Application
Time frame: At baseline
Postural alignment parameters, including head position, shoulder alignment, spinal posture, and pelvic alignment (uygun olanları siz düzenleyin), will be quantitatively assessed using the PostureScreen Mobile® application.
Muscle Stiffness (N/m) of the Masseter, Temporalis, and Trapezius Muscles Assessed Using the MyotonPRO Device
Time frame: At baseline
Muscle stiffness will be quantitatively assessed in the masseter, temporalis, and trapezius muscles using the MyotonPRO handheld myotonometer. Stiffness will be recorded in Newtons per meter (N/m) as the primary biomechanical parameter used for evaluation.
2 secondary outcomes
Sleep Quality
Time frame: At baseline
Perceived Stress
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Background: PubMed 17922157Izci B, Ardic S, Firat H, Sahin A, Altinors M, Karacan I. Reliability and validity studies of the Turkish version of the Epworth Sleepiness Scale. Sleep Breath. 2008 May;12(2):161-8. doi: 10.1007/s11325-007-0145-7.
- Background: PubMed 29410561Szucs KA, Brown EVD. Rater reliability and construct validity of a mobile application for posture analysis. J Phys Ther Sci. 2018 Jan;30(1):31-36. doi: 10.1589/jpts.30.31. Epub 2018 Jan 27.
- Background: PubMed 38100233Xiong X, Xiao CQ, Yang YC, Li YJ, Cheng QY, Wang XY, Liu Y. Temporomandibular disorder patients with excessive daytime sleepiness present greater pain intensity and reduced jaw function. J Oral Rehabil. 2024 Apr;51(4):639-647. doi: 10.1111/joor.13639. Epub 2023 Dec 15.
- 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.
Emine Nur Demircan, Asst. Prof. principal investigator
Istanbul Kent University
Berfin Erdemli, Res. Asst. study director
Istanbul Kent University
Melis Usul, Res. Asst. study director
Istanbul Kent University
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 Bruxism and Posture, run by Istanbul Kent 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 1 May 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Jaw Functional Limitation Total Score Assessed Using the 20-Item Jaw Functional Limitation Scale (JFLS-20) (time frame: At baseline (study enrollment)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07560670, which also lists 3 linked publications.
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 1 May 2026.