- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07308145
The Effect of Bruxism on Balance
The Effect of Bruxism on Dynamic Balance in Desk Workers
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Hajar Alkassab
- Phone Number: +905525885429
- Email: hajarb2015@gmail.com
Study Contact Backup
- Name: Vedat Göken
- Phone Number: +905364262835
- Email: vedatgoken@hotmail.com
Study Locations
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Istanbul, Turkey (Türkiye), 34522
- Recruiting
- Istinye University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age between 18 and 50 years,
- Participants must be diagnosed with bruxism by a dentist,
- Voluntary participation and signing the informed consent form,
- The participant must have the cognitive capacity to communicate and understand instructions,
- Desk work hours must be at least 4 hours.
Exclusion Criteria:
- Unable to cooperate,
- Having active inflammatory arthritis,
- Having had hip or knee surgery within the last 3 months,
- Having a diagnosed psychiatric illness,
- Having dentofacial anomalies,
- Being pregnant,
- Having a physical or cognitive condition that would prevent completion of the given test protocols,
- Inability to comply with or cooperate with test procedures during the measurement period.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Bruxism group
Bruxism group: Adults aged 18-50 years who have bruxism symptoms. Participants will undergo assessments of Masseter muscle stiffness, trigger points, quality of life, sleep quality, and dynamic balance. No experimental interventions are assigned. |
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Non-bruxism group
Non-bruxism group: Adults aged 18-50 years those who do not have bruxism symptoms. Participants will undergo assessments of Masseter muscle stiffness, trigger points, quality of life, sleep quality, and dynamic balance. No experimental interventions are assigned. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Short Form 36 (SF-36)
Time Frame: Single assessment during study visit (1 day)
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Quality of Life Scale/Short Form-36 (SF-36): SF-36 was developed by the Rand Corporation to obtain information about the health status of the individual.
It was translated into Turkish by Koçyiğit and his colleagues, who conducted a validity and reliability study.
It consists of eight sub-dimensions and 36 items.
The sub-dimensions consist of physical function, social function, physical role difficulty, emotional state difficulty, mental health, energy/vitality, pain, and general perception of health.
A score of "0" represents the worst health status, while "100" represents the best health status.
Each sub-dimension is evaluated individually without calculating the total score.
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Single assessment during study visit (1 day)
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Pittsburgh Sleep Quality Index
Time Frame: Single assessment during study visit (1 day)
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Pittsburgh Sleep Quality Index (PSQI): It is a 24-question scale developed by Buysse et al. in 1989 that evaluates sleep quality in the last month.
A Turkish validity and reliability study was performed in 1996.
The sum of the scores of seven components, subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, sleep medication use, and daytime dysfunction, gives the total score index.
The total PSQI score ranges from 0 to 21; a score above 5 points indicates poor sleep quality; a score of 5 points or less indicates good sleep quality.
The PSQI is one of the most commonly used scales for evaluating sleep quality.
The validity of the use of this index in sleep disorders has been tested before, and it has been frequently used in studies on bruxism.
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Single assessment during study visit (1 day)
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Beck Anxiety Inventory (BAI)
Time Frame: Single assessment during study visit (1 day)
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This scale's 21 items describe the most typical symptoms of anxiety disorders.
It was developed to measure the intensity of anxiety symptoms in clinical populations.
It asks respondents to indicate how much they have been affected by each symptom during the last week, on a scale from 0 (Not at all) to 3 (Severely - I could barely stand it).
Total scores are the sum of all item scores, and range from 0 to 63; higher scores indicate higher anxiety.
When this instrument was developed, the goal was to more easily discriminate between anxiety disorders and depressive disorders, whose symptoms frequently overlap on other assessment tools.
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Single assessment during study visit (1 day)
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Fonseca Anamnestic Index
Time Frame: Single assessment during study visit (1 day)
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Fonseca Anamnestic Index (FAI): It was developed in 1994 by Fonseca et al. and consists of 10 questions investigating pain in the head and TMJ.
Turkish validity and reliability of the test was performed by Kaynak et al.
The questionnaire includes various questions about joint, head, and neck pain; joint movements; parafunctional habits; impaired occlusion; and emotional stress.
Participants were asked to answer "Yes" , "Sometimes" , or "No" to each question, and TMD was classified as none, mild, moderate, or severe according to the total score.
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Single assessment during study visit (1 day)
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Pain level-Visual Analog Scale (VAS)
Time Frame: Single assessment during study visit (1 day)
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Pain level-Visual Analog Scale: A visual analog scale (VAS) was used to assess the severity of pain related to bruxism.
A VAS line was drawn on a 10 cm long horizontal line (0 = no pain and 10 = most intense pain), and the patient was asked to mark the pain intensity they perceived at rest, active use, and at night on this VAS line.
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Single assessment during study visit (1 day)
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Perceived Stress Scale
Time Frame: Single assessment during study visit (1 day)
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Perceived Stress Scale: It was developed by Cohen, Kamarck, and Mermelstein in 1983 and consists of 14 items.
Its Turkish validity and reliability was performed by Eskin et al., and this scale has been used in many studies on bruxism.
The scale consists of two subdimensions: stress/discomfort perception and self-efficacy perception.
Participants rate the stress they perceive on the scale as "0" never, "1" almost never, "2" sometimes, "3" often, and "4" very often.
The stress level perceived by individuals is determined by summing the scores obtained from the items.
A score between 0-56 points is obtained from the scale, and the higher the score, the higher the perceived stress level.
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Single assessment during study visit (1 day)
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Measurement of dynamic balance
Time Frame: Single assessment during study visit (1 day)
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Balance assessments will be performed using Computerized Posturography (ProKin 252, Tecnobody, Dalmine, Italy), this device provides objectively measurable data for balance measurements. TecnoBody Prokin 252 will be used to measure and evaluate the patient's dinamik balance and proprioception levels in detail. |
Single assessment during study visit (1 day)
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Evaluation of the Masseter's muscle stiffness
Time Frame: Single assessment during study visit (1 day)
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Masseter's muscle stiffness will be assessed with MyotonPRO.
MyotonPRO (Muomeetria Ltd., Tallinn, Estonia) is a hand-held device used to quantify muscle stiffness.
This device operates by generating a mechanical impulse on the skin overlying the muscle being assessed, followed by MyotonPRO measurements of the mechanical oscillations of muscles produced by the mechanical impulse.
This method can determine the resistance of the muscle to deforming forces or muscle stiffness.
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Single assessment during study visit (1 day)
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Trigger Point Evaluation
Time Frame: Single assessment during study visit (1 day)
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Trigger points in trapezius, masseter and temporalis muscles will be evaluated by algometre. Sudden reaction or vocal response of the patient with light pressure applied to this point and the presence of reflected pain in a region distant from this region indicated the presence of a trigger point (the minimum and maximum pressure sensitivity range varies from person to person, as it differs in sensitivity). |
Single assessment during study visit (1 day)
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Kadioglu MB, Sezer M, Elbasan B. Effects of Manual Therapy and Home Exercise Treatment on Pain, Stress, Sleep, and Life Quality in Patients with Bruxism: A Randomized Clinical Trial. Medicina (Kaunas). 2024 Dec 4;60(12):2007. doi: 10.3390/medicina60122007.
- Chen Z, Shen Z, Ye X, Wu J, Wu H, Xu X. Association between Foot Posture Asymmetry and Static Stability in Patients with Knee Osteoarthritis: A Case-Control Study. Biomed Res Int. 2020 Jun 5;2020:1890917. doi: 10.1155/2020/1890917. eCollection 2020.
- Silveira AM, Cericato GO, Meusel LDZV, Girotto LPDS, Bacchi A, Silva-Sousa YTC. Prevalence of temporomandibular disorders and associated factors: a population-based study in southern Brazil. Braz Oral Res. 2025 Sep 8;39:e092. doi: 10.1590/1807-3107bor-2025.vol39.092. eCollection 2025.
- Divya M, Abinaya S, Alkousar Taz M, Manavalan N, Nivethitha L, Mooventhan A. Impact of yoga and naturopathy in a patient with unilateral Meniere's disease associated with pangastritis: A case report. J Bodyw Mov Ther. 2025 Dec;45:225-228. doi: 10.1016/j.jbmt.2025.08.032. Epub 2025 Aug 29.
- Petzold Werle S, da Silveira J, de Azevedo Guimaraes AC. Effects of dance therapy on anxiety, stress, optimism and depressive symptoms in women undergoing breast cancer surgery: a randomized clinical trial. J Bodyw Mov Ther. 2025 Dec;45:516-523. doi: 10.1016/j.jbmt.2025.08.030. Epub 2025 Sep 4.
- Huang D, Ke X, Jiang C, Song W, Feng J, Zhou H, Zhang R, Zhang A, Lan F. Effects of 12 weeks of Tai Chi on neuromuscular responses and postural control in elderly patients with sarcopenia: a randomized controlled trial. Front Neurol. 2023 Apr 28;14:1167957. doi: 10.3389/fneur.2023.1167957. eCollection 2023.
- Luo W, Huang Z, Li H, Zhong T, Chen P, Min Y. Regulation of static and dynamic balance in healthy young adults: interactions between stance width and visual conditions. Front Bioeng Biotechnol. 2025 Jan 28;13:1538286. doi: 10.3389/fbioe.2025.1538286. eCollection 2025.
- Luo W, Min Y, Chen P, Li H, Long Z, Sun J, Zhong T. Dual analysis of postural control in middle-aged and elderly patients with cervicogenic dizziness: Dynamic and static balance perspectives. Front Bioeng Biotechnol. 2025 Jul 22;13:1622648. doi: 10.3389/fbioe.2025.1622648. eCollection 2025.
- Campos Lopez A, Estebanez-de-Miguel E, Camou Acedo T, Garcia-Pelagio KP, Albarova-Corral I, Malo Urries M, Villanueva-Melendez P. Reliability of myotonometry in the assessment of cervico-mandibular musculature: Inter/intra-examiner and inter/intra-session reliability study. Cranio. 2025 Jul 7:1-10. doi: 10.1080/08869634.2025.2528304. Online ahead of print.
- Ucar I, Kararti C, Dadali Y, Ozudogru A, Okcu M. Masseter Muscle Thickness And Elasticity in Bruxism After Exercise Treatment: A Comparison Trial. J Manipulative Physiol Ther. 2022 May;45(4):282-289. doi: 10.1016/j.jmpt.2022.07.004. Epub 2022 Aug 31.
- Galczynska-Rusin M, Pobudek-Radzikowska M, Gawriolek K, Czajka-Jakubowska A. Gender-Related Biomechanical Properties of Masseter Muscle among Patients with Self-Assessment of Bruxism: A Comparative Study. J Clin Med. 2022 Feb 5;11(3):845. doi: 10.3390/jcm11030845.
- Yagci I, Tasdelen Y, Kivrak Y. Childhood Trauma, Quality of Life, Sleep Quality, Anxiety and Depression Levels in People with Bruxism. Noro Psikiyatr Ars. 2020 Mar 2;57(2):131-135. doi: 10.29399/npa.23617. eCollection 2020 Jun.
- Machado NAG, Costa YM, Quevedo HM, Stuginski-Barbosa J, Valle CM, Bonjardim LR, Garib DG, Conti PCR. The association of self-reported awake bruxism with anxiety, depression, pain threshold at pressure, pain vigilance, and quality of life in patients undergoing orthodontic treatment. J Appl Oral Sci. 2020 Mar 27;28:e20190407. doi: 10.1590/1678-2019-0407. eCollection 2020.
- Santos Miotto Amorim C, Firsoff EF, Vieira GF, Costa JR, Marques AP. Effectiveness of two physical therapy interventions, relative to dental treatment in individuals with bruxism: study protocol of a randomized clinical trial. Trials. 2014 Jan 7;15:8. doi: 10.1186/1745-6215-15-8.
- Abasiyanik Z, Kopruluoglu M, Ucurum SG, Kahraman T, Kurt M, Keskin M, Kaya DO. Association Between Spinal Curvature and Mobility and Balance Abilities in Young Soccer Players. Percept Mot Skills. 2025 Oct;132(5):988-1004. doi: 10.1177/00315125251338539. Epub 2025 May 13.
- Yu JF, Chang TT, Zhang ZJ. The Reliability of MyotonPRO in Assessing Masseter Muscle Stiffness and the Effect of Muscle Contraction. Med Sci Monit. 2020 Nov 2;26:e926578. doi: 10.12659/MSM.926578.
- Vazquez Morejon AJ, Vazquez-Morejon Jimenez R, Zanin GB. Beck Anxiety Inventory: psychometric characteristics in a sample from the clinical Spanish population. Span J Psychol. 2014 Oct 28;17:E76. doi: 10.1017/sjp.2014.76.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-250
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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