BruxismBruxismNCT07028151
Comparison of the Effects of Classical Massage and Conventional Treatment Methods in Phone Addicted Bruxist Patients
A study testing manual therapy and Conventional Therapy in people with Bruxism and Physiotherapy, run by Bartın Unıversity at 1 site in Turkey (Türkiye).
Trial summary
Bruxism, defined as the involuntary clenching or grinding of teeth during sleep or wakefulness, is a common condition with multifactorial etiology. It can lead to various complications including temporomandibular joint (TMJ) pain, masticatory muscle hypertrophy, dental wear, headaches, and postural dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 27 years
- Conditions the study is for
- Bruxism, Physiotherapy, Orafacial Pain
- What is being tested?
- manual therapy and Conventional Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 27 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Volunteer students aged between 18-27
- Having at least two clinical signs of bruxism Abnormal tooth wear on the occlusal surfaces of the teeth Abfraction Gingival recession and/or cervical defect Tongue indentations or damage to the inside of the cheek Tense facial and jaw muscles, muscle sensitivity, and masseteric hypertrophy upon bidigital palpation
Who cannot join
- Characterized by a neurological disease,
- Botulinum toxin injections into the masticatory muscles in the last year,
- Using antidepressant-type medications that will affect the central nervous system,
- Receiving occlusal splint treatment,
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Bartın University, Health Services Vocational School
Bartın, Ankara
About this study
Bruxism, defined as the involuntary clenching or grinding of teeth during sleep or wakefulness, is a common condition with multifactorial etiology. It can lead to various complications including temporomandibular joint (TMJ) pain, masticatory muscle hypertrophy, dental wear, headaches, and postural dysfunction. Although its underlying causes remain unclear, stress, poor sleep quality, postural problems, and excessive smartphone use have been identified as potential contributing factors.
Recent studies suggest a significant relationship between bruxism and psychological as well as behavioral variables such as stress levels, screen time, and physical inactivity. University students, due to academic pressure and lifestyle habits, may be particularly vulnerable.
This study aims to investigate the relationship between bruxism and smartphone addiction, sleep quality, and perceived stress among associate degree students at Bartın University. By identifying these associations, the study seeks to contribute to preventive strategies and promote awareness of bruxism-related risk factors in young adults.
Read the detailed description
Bruxism is a common multidisciplinary condition characterized by involuntary teeth clenching or grinding that occurs during sleep or wakefulness. Although bruxism episodes are typically short in duration, they can lead to significant complications involving the masticatory muscles and postural system, including temporomandibular joint (TMJ) pain and dysfunction, headaches, dental wear, hypersensitivity, tooth pain, hypertrophy of the masticatory muscles, implant fractures, and joint sounds. While its etiology is not fully understood, bruxism is believed to be multifactorial. Studies suggest that a lifestyle characterized by chronic stress and smartphone dependency may trigger or exacerbate bruxism. Additionally, poor sleep quality and postural abnormalities have been shown to influence both bruxism and emotional stress levels, while low levels of physical activity may further impair sleep and increase stress.
The aim of this study is to improve symptoms and enhance the quality of life in individuals with smartphone addiction and bruxism complaints through the application of different physiotherapy interventions.
Following the approval of the Ethics Committee of Bartın University Vocational School of Health Services, the study will be initiated. Data collection will take place between May 2025 and September 2025. A total of 30 university students diagnosed with bruxism and enrolled at Bartın University will be included in the study. Participants will be randomly assigned using a coin toss method into two groups: a massage group (MG, n=15) receiving classical face and neck massage, and a treatment group (TG, n=15) undergoing a conventional physiotherapy program including transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound, and infrared heat therapy.
After obtaining written informed consent from eligible participants, all assessments will be conducted in the same order by a blinded assessor. Following baseline evaluations, participants will undergo 10 sessions of their respective treatment protocols, each lasting approximately 40 minutes. The MG will receive classical massage, while the TG will receive TENS, ultrasound, and infrared therapy. After completion of the intervention sessions, post-treatment evaluations will be carried out by the same assessor, and the data will be subjected to statistical analysis.
- Conditions
- Bruxism, Physiotherapy, Orafacial Pain
- Being tested
- manual therapy, Conventional Therapy
- Keywords
- Bruxism, Physical Therapy, Massage, TENS, Ultrasound, Pain
- Medical subject headings
- Bruxism, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manual therapyOther
Participants who meet the inclusion criteria will be evaluated following the acquisition of written informed consent. Treatment will be administered with participants in the supine position. Initially, soft tissue mobilization will be applied to the cervical extensor muscle group, followed by gentle cervical vertebral traction. Subsequently, a classical facial massage will be performed. The massage will include the suprahyoid muscles and the medial pterygoid. Intramuscular stretching and friction massage techniques will be applied to the masseter and anterior temporalis muscles. Each session will last approximately 40 minutes and will be conducted over a total of 10 sessions."
Conventional TherapyOther
Participants who meet the inclusion criteria will be evaluated after providing written informed consent. Treatment will be administered with participants in the supine position. Protective goggles will be placed on the participants' eyes prior to the infrared therapy application. Following 20 minutes of infrared treatment, ultrasound (1 MHz) will be applied to the masseter muscle using the full-contact method for 3 minutes. Finally, transcutaneous electrical nerve stimulation (TENS) will be applied to the masseter and anterior temporalis muscles for 15 to 20 minutes. Each session will last approximately 40 minutes and will be conducted over a total of 10 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Manual Therapy | Experimental | Participants who meet the inclusion criteria will be evaluated after providing written informed consent and will receive 10 sessions of approximately 40 minutes of classical face and neck massage Receives: Other: manual therapy |
| Conventional Therapy | Experimental | Participants who meet the inclusion criteria will be evaluated after providing written informed consent and will commence the treatment sessions. Each session will consist of sequential applications of infrared therapy, ultrasound, and transcutaneous electrical nerve stimulation (TENS). The sessions, lasting approximately 40 minutes each, will be conducted over a total of 10 days Receives: Other: Conventional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Level
A visual analog scale (VAS) will be used to assess the severity of pain associated with bruxism. The patient will be asked to mark the severity of pain perceived at rest, during active use, and at night on a 10 cm long horizontal line with the words "0 (no pain)" at the beginning and "10 (most intense pain)" at the end. The individual's pain severity will be recorded by measuring the distance marked on the line in millimeters.
Measured: From baseline to the end of treatment at 10 days
Pressure pain threshold
Pressure pain threshold measurement will be used for digital algometer (Lafayette Manual Muscle Test System ™, Model 01163, Lafayette Instrument Company, Lafayette, In, USA). Before the measurement, all individuals will be informed about the test. During the measurement, individuals will be asked to sit in a comfortable and neutral position in a comfortable and neutral position to come into contact with the soles of the foot. Masseter and temporalis anterior's most swollen, upper trapeze is painful nervous point. The pressure will be applied with a disk head of 1 cm² and the power unit will be set to kg/cm². Values will be recorded by telling the patient to give a "stop" command as soon as he first feels the pain. The averages will be taken twice from the same point.
Measured: From baseline to the end of treatment at 10 days
Secondary outcomes (4)
Range of motion
Cervical flexion, extension, lateral flexion and rotation degrees will be evaluated with universal gonyometer before and after treatment. The ruler will be used to evaluate the maximum oral opening, right left lateral shifts.
Measured: From baseline to the end of treatment at 10 days
The Depression-Anxiety-Stress Scale (DAS)
The Depression-Anxiety-Stress Scale (DAS), developed by Lovibond, was converted into a 21-item short form by Henry and Crawford and adapted to Turkish by Sarıçam (Henry \& Crawford, 2005; Lovibond \& Lovibond, 1995; Sariçam, 2018). Cronbach's alpha internal consistency reliability coefficient was found to be α=0.87 for the depression subscale, α=0.85 for the anxiety subscale, and α=0.81 for the stress subscale. The 4-point Likert-type scale includes 7 questions to measure depression, stress, and anxiety dimensions, and each section is evaluated within itself. According to the total scores obtained, classification is made as normal, mild, moderate, severe, and very severe.
Measured: From baseline to the end of treatment at 10 days
Insomnia Severity Index (ISI)
It was published by Morin in 1993, and the first psychometric evaluations were published in 2001. The scale, whose Turkish reliability and validity were made by Boysan et al., consists of 7 questions and each item is scored between 0-4. In addition to being a self-reporting tool, the scale is also a tool that can be used by a clinician or another person (e.g. spouse) in evaluation.
Measured: From baseline to the end of treatment at 10 days
Bruxism
It was examined with Bruxism Questionnaire. According to the survey questions prepared by referencing the studies of Pintado et al and Shetty et al, it was stated that individuals who answered "Yes" to at least two of the questions specified in the survey can be called bruxists. The total score range varies between 0-6.
Measured: From baseline to the end of treatment at 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start1 Apr 2024
- Primary completion4 Jun 2025
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Thirty patients with bruxism were randomly divided into as Manual Therapy Group (15) and Conventional Treatment Group (15).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bartın Unıversity
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Miraç Sezer, Bartın Unıversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028151
- Sponsor's protocol ID
- 2025-SBB-0226
- Acronym
- Bruxism
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We can share the questionnaires and indexes used in the study
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Classical Massage and Conventional Treatment Methods in Phone Addicted Bruxist Patients
- ClinicalTrials.gov ID
- NCT07028151
- Acronym / sponsor ID
- Bruxism / 2025-SBB-0226
- Conditions
- Bruxism, Physiotherapy, Orafacial Pain
- Keywords
- Bruxism, Physical Therapy, Massage, TENS, Ultrasound, Pain
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Bartın UnıversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 4 Jun 2025 (actual)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 19 Jun 2025 (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, defined as the involuntary clenching or grinding of teeth during sleep or wakefulness, is a common condition with multifactorial etiology. It can lead to various complications including temporomandibular joint (TMJ) pain, masticatory muscle hypertrophy, dental wear, headaches, and postural dysfunction. Although its underlying causes remain unclear, stress, poor sleep quality, postural problems, and excessive smartphone use have been identified as potential contributing factors.
Recent studies suggest a significant relationship between bruxism and psychological as well as behavioral variables such as stress levels, screen time, and physical inactivity. University students, due to academic pressure and lifestyle habits, may be particularly vulnerable.
This study aims to investigate the relationship between bruxism and smartphone addiction, sleep quality, and perceived stress among associate degree students at Bartın University. By identifying these associations, the study seeks to contribute to preventive strategies and promote awareness of bruxism-related risk factors in young adults.
Detailed description
Bruxism is a common multidisciplinary condition characterized by involuntary teeth clenching or grinding that occurs during sleep or wakefulness. Although bruxism episodes are typically short in duration, they can lead to significant complications involving the masticatory muscles and postural system, including temporomandibular joint (TMJ) pain and dysfunction, headaches, dental wear, hypersensitivity, tooth pain, hypertrophy of the masticatory muscles, implant fractures, and joint sounds. While its etiology is not fully understood, bruxism is believed to be multifactorial. Studies suggest that a lifestyle characterized by chronic stress and smartphone dependency may trigger or exacerbate bruxism. Additionally, poor sleep quality and postural abnormalities have been shown to influence both bruxism and emotional stress levels, while low levels of physical activity may further impair sleep and increase stress.
The aim of this study is to improve symptoms and enhance the quality of life in individuals with smartphone addiction and bruxism complaints through the application of different physiotherapy interventions.
Following the approval of the Ethics Committee of Bartın University Vocational School of Health Services, the study will be initiated. Data collection will take place between May 2025 and September 2025. A total of 30 university students diagnosed with bruxism and enrolled at Bartın University will be included in the study. Participants will be randomly assigned using a coin toss method into two groups: a massage group (MG, n=15) receiving classical face and neck massage, and a treatment group (TG, n=15) undergoing a conventional physiotherapy program including transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound, and infrared heat therapy.
After obtaining written informed consent from eligible participants, all assessments will be conducted in the same order by a blinded assessor. Following baseline evaluations, participants will undergo 10 sessions of their respective treatment protocols, each lasting approximately 40 minutes. The MG will receive classical massage, while the TG will receive TENS, ultrasound, and infrared therapy. After completion of the intervention sessions, post-treatment evaluations will be carried out by the same assessor, and the data will be subjected to statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Thirty patients with bruxism were randomly divided into as Manual Therapy Group (15) and Conventional Treatment Group (15).
| Arm | Type | Receives |
|---|---|---|
| Manual Therapy | Experimental | Other: manual therapyParticipants who meet the inclusion criteria will be evaluated after providing written informed consent and will receive 10 sessions of approximately 40 minutes of classical face and neck massage |
| Conventional Therapy | Experimental | Other: Conventional TherapyParticipants who meet the inclusion criteria will be evaluated after providing written informed consent and will commence the treatment sessions. Each session will consist of sequential applications of infrared therapy, ultrasound, and transcutaneous electrical nerve stimulation (TENS). The sessions, lasting approximately 40 minutes each, will be conducted over a total of 10 days |
Who may qualify
- Ages
- 18 to 27 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Volunteer students aged between 18-27
- Having at least two clinical signs of bruxism Abnormal tooth wear on the occlusal surfaces of the teeth Abfraction Gingival recession and/or cervical defect Tongue indentations or damage to the inside of the cheek Tense facial and jaw muscles, muscle sensitivity, and masseteric hypertrophy upon bidigital palpation
Key exclusion criteria (4 listed)
- Characterized by a neurological disease,
- Botulinum toxin injections into the masticatory muscles in the last year,
- Using antidepressant-type medications that will affect the central nervous system,
- Receiving occlusal splint treatment,
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 |
|---|---|---|
| manual therapyParticipants who meet the inclusion criteria will be evaluated following the acquisition of written informed consent. Treatment will be administered with participants in the supine position. Initially, soft tissue mobilization will be applied to the cervical extensor muscle group, followed by gentle cervical vertebral traction. Subsequently, a classical facial massage will be performed. The massage will include the suprahyoid muscles and the medial pterygoid. Intramuscular stretching and friction massage techniques will be applied to the masseter and anterior temporalis muscles. Each session will last approximately 40 minutes and will be conducted over a total of 10 sessions." | Other | Manual Therapy |
| Conventional TherapyParticipants who meet the inclusion criteria will be evaluated after providing written informed consent. Treatment will be administered with participants in the supine position. Protective goggles will be placed on the participants' eyes prior to the infrared therapy application. Following 20 minutes of infrared treatment, ultrasound (1 MHz) will be applied to the masseter muscle using the full-contact method for 3 minutes. Finally, transcutaneous electrical nerve stimulation (TENS) will be applied to the masseter and anterior temporalis muscles for 15 to 20 minutes. Each session will last approximately 40 minutes and will be conducted over a total of 10 sessions. | Other | Conventional Therapy |
Primary outcome
Pain Level
Time frame: From baseline to the end of treatment at 10 days
A visual analog scale (VAS) will be used to assess the severity of pain associated with bruxism. The patient will be asked to mark the severity of pain perceived at rest, during active use, and at night on a 10 cm long horizontal line with the words "0 (no pain)" at the beginning and "10 (most intense pain)" at the end. The individual's pain severity will be recorded by measuring the distance marked on the line in millimeters.
Pressure pain threshold
Time frame: From baseline to the end of treatment at 10 days
Pressure pain threshold measurement will be used for digital algometer (Lafayette Manual Muscle Test System ™, Model 01163, Lafayette Instrument Company, Lafayette, In, USA). Before the measurement, all individuals will be informed about the test. During the measurement, individuals will be asked to sit in a comfortable and neutral position in a comfortable and neutral position to come into contact with the soles of the foot. Masseter and temporalis anterior's most swollen, upper trapeze is painful nervous point. The pressure will be applied with a disk head of 1 cm² and the power unit will be set to kg/cm². Values will be recorded by telling the patient to give a "stop" command as soon as he first feels the pain. The averages will be taken twice from the same point.
4 secondary outcomes
Range of motion
Time frame: From baseline to the end of treatment at 10 days
The Depression-Anxiety-Stress Scale (DAS)
Time frame: From baseline to the end of treatment at 10 days
Insomnia Severity Index (ISI)
Time frame: From baseline to the end of treatment at 10 days
Bruxism
Time frame: From baseline to the end of treatment at 10 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Individual participant dataSharing planned: Yes. We can share the questionnaires and indexes used in the study
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing manual therapy and Conventional Therapy in people with Bruxism and Physiotherapy, run by Bartın Unıversity 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 2 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: enrolling by invitation, as of the sponsor's last update on 19 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Pain Level (time frame: From baseline to the end of treatment at 10 days). The study lists 2 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 19 Jun 2025; AzTrials last refreshed its copy on 7 Nov 2026.