BruxismNCT07827495
Synchronous vs Asynchronous Telerehabilitation for Bruxism
A study testing Synchronous Telerehabilitation Protocol and Asynchronous Telerehabilitation Protocol in people with Bruxism and Sleep Bruxism, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial was to learn if online exercise and self-massage programs could lower pain and improve jaw movement in adults with bruxism (teeth grinding or clenching). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bruxism, Sleep Bruxism
- What is being tested?
- Synchronous Telerehabilitation Protocol and Asynchronous Telerehabilitation Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 30 Apr 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with clinically-based bruxism
- Aged 18 years or older
- Voluntarily agreed to participate and provided written informed consent
Who cannot join
- Prior or concurrent neurological, psychiatric, or systemic diseases
- Ongoing dental treatment
- Currently receiving physical therapy
- Regular use of medications such as analgesics or muscle relaxants
- History of surgery or trauma involving the temporomandibular joint (TMJ) or neck region
- Pregnancy
Show all 10Show fewer
- Active cancer
- Planned surgical procedures
- Visual, auditory, or cognitive impairments that could potentially confound the study outcomes
- History of receiving treatment for the TMJ within the preceding 3 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University, Faculty of Dentistry
Ankara
About this study
Official title: Synchronous vs Asynchronous Telerehabilitation for Bruxism: A Randomized Controlled Trial
The goal of this clinical trial was to learn if online exercise and self-massage programs could lower pain and improve jaw movement in adults with bruxism (teeth grinding or clenching). The main questions it aimed to answer were:
Did live video exercise guided by a physical therapist lower jaw pain more than an independent video exercise program? Did live video exercise guided by a physical therapist improve mouth opening more than an independent video exercise program? Researchers compared live video sessions to independent video exercises to see which approach worked better for improving jaw function, sleep quality, and daily life.
Read more
Participants:
Completed an 8-session exercise and self-massage program over 4 weeks (2 times each week).
Either practiced live with a physical therapist over video calls or followed recorded video exercises on their own at home.
Answered surveys about pain, sleep quality, and oral health before and after the 4-week program.
Had their mouth opening, jaw muscle sensitivity, and muscle activity tested before and after the program.
Read the detailed description
Bruxism is characterized by repetitive masticatory muscle activity leading to masticatory muscle pain, restricted mandibular range of motion, and impaired oral health-related quality of life. Telerehabilitation represents a promising alternative to conventional face-to-face physiotherapy to overcome accessibility barriers.
In this prospective, randomized, two-arm parallel-group controlled trial, individuals diagnosed with clinically-based bruxism were randomly assigned to either the Synchronous Telerehabilitation Group (S-TRG) or the Asynchronous Telerehabilitation Group (A-TRG).
Both groups completed an 8-session intervention protocol over 4 weeks (2 sessions per week). The intervention protocol comprised:
Breathing training protocol (deep diaphragmatic breathing), Cervical region stretching and chin-tuck exercises, Temporomandibular joint range of motion and stretching exercises, Bilateral self-massage techniques (sliding, kneading, friction, and ischemic compression to masseter and temporalis muscles), Scapular stabilization exercises (W, T, and Y exercises).
In the S-TRG, sessions were conducted in real time under the direct supervision of a physiotherapist via live video calls. In the A-TRG, participants were taught the exercises in an initial recorded live video session and subsequently performed the protocol independently using their personalized instructional video recordings, with weekly phone/text check-ins to monitor adherence and screen for adverse events. Additionally, all participants received a standardized patient education brochure on TMJ care and behavioral modifications.
Outcome assessments were conducted at baseline and immediately following the 4-week intervention period. Evaluated parameters included:
Pain intensity assessed using the 0-10 Numeric Rating Scale (NRS) at rest, during the night, in the morning, and during activity, Maximum mouth opening (MMO) measured with a caliper, Pressure pain threshold (PPT) and pressure pain tolerance (PPTol) of the masseter and temporalis anterior muscles assessed using a digital algometer, Masticatory muscle activation during maximum voluntary isometric contraction and clenching tasks assessed via surface electromyography (sEMG), Oral health-related quality of life evaluated using the 14-item Oral Health Impact Profile (OHIP-14), Subjective sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI).
- Conditions
- Bruxism, Sleep Bruxism
- Being tested
- Synchronous Telerehabilitation Protocol, Asynchronous Telerehabilitation Protocol
- Keywords
- Telerehabilitation, Exercise Therapy, Self-Massage, Temporomandibular Disorder, Electromyography
- Medical subject headings
- Bruxism, Sleep Bruxism, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synchronous Telerehabilitation ProtocolBehavioural
Real-time video-supervised protocol consisting of diaphragmatic breathing, cervical stretching, TMJ range of motion and self-stretching, bilateral masseter/temporalis self-massage, scapular stabilization exercises, and TMJ education brochure (8 sessions over 4 weeks).
Asynchronous Telerehabilitation ProtocolBehavioural
Video-recorded home protocol consisting of identical diaphragmatic breathing, cervical stretching, TMJ range of motion/self-stretching, bilateral self-massage, scapular exercises, and TMJ education brochure performed independently with weekly check-ins (8 sessions over 4 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Synchronous Telerehabilitation Group (S-TRG) | Experimental | Participants completed an 8-session therapeutic exercise and self-massage program over 4 weeks (2 sessions per week) via real-time live video calls under the direct supervision of a physiotherapist. They also received TMJ patient education and behavioral modification brochures. Receives: Behavioral: Synchronous Telerehabilitation Protocol |
| Asynchronous Telerehabilitation Group (A-TRG) | Active comparator | Participants were taught the same 8-session exercise and self-massage protocol in an initial live recorded video session and subsequently performed the exercises independently at home for 4 weeks using personalized video recordings, supported by weekly check-ins. They also received TMJ patient education and behavioral modification brochures. Receives: Behavioral: Asynchronous Telerehabilitation Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity
Assessed using the Numeric Rating Scale (NRS), an 11-point scale ranging from 0 (no pain) to 10 (worst possible pain). Pain intensity is evaluated at rest, during the night, in the morning upon waking, and during jaw activity/function.
Measured: Baseline and post-intervention (Week 4)
Secondary outcomes (6)
Change in Maximum Mouth Opening (MMO)
Maximum active mouth opening without pain measured in centimeters (cm) using a caliper between the incisal edges of the maxillary and mandibular central incisors.
Measured: Baseline and post-intervention (Week 4)
Change in Pressure Pain Threshold (PPT)
Assessed in pounds (lb) using a digital algometer (1 cm² probe) over the bilateral masseter and anterior temporalis muscles to determine the minimum force at which pressure sensation transitions into pain.
Measured: Baseline and post-intervention (Week 4)
Change in Pressure Pain Tolerance (PPTol)
Assessed in pounds (lb) using a digital algometer (1 cm² probe) over the bilateral masseter and anterior temporalis muscles to determine the maximum level of pressure pain tolerated.
Measured: Baseline and post-intervention (Week 4)
Change in Masticatory Muscle Activity (sEMG)
Assessed via surface electromyography (sEMG) to evaluate muscle activation of the masseter and temporalis anterior muscles during maximum voluntary isometric contraction (MVIC) and clenching tasks.
Measured: Baseline and post-intervention (Week 4)
Change in Oral Health-Related Quality of Life (OHIP-14)
Evaluated using the Oral Health Impact Profile-14 (OHIP-14). Total scores range from 0 to 56, with higher scores indicating poorer oral health-related quality of life.
Measured: Baseline and post-intervention (Week 4)
Change in Subjective Sleep Quality (PSQI)
Assessed using the Pittsburgh Sleep Quality Index (PSQI). The global score ranges from 0 to 21, with scores greater than 5 indicating poor sleep quality.
Measured: Baseline and post-intervention (Week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start1 Aug 2025
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
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
- Participants are randomized into two parallel groups: Synchronous Telerehabilitation Group (S-TRG) or Asynchronous Telerehabilitation Group (A-TRG).
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze COBANOGLU, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07827495
- Sponsor's protocol ID
- 2025-1320
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synchronous vs Asynchronous Telerehabilitation for Bruxism: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07827495
- Acronym / sponsor ID
- 2025-1320
- Conditions
- Bruxism, Sleep Bruxism
- Keywords
- Telerehabilitation, Exercise Therapy, Self-Massage, Temporomandibular Disorder, Electromyography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 18 Sep 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.
The goal of this clinical trial was to learn if online exercise and self-massage programs could lower pain and improve jaw movement in adults with bruxism (teeth grinding or clenching). The main questions it aimed to answer were:
Did live video exercise guided by a physical therapist lower jaw pain more than an independent video exercise program? Did live video exercise guided by a physical therapist improve mouth opening more than an independent video exercise program? Researchers compared live video sessions to independent video exercises to see which approach worked better for improving jaw function, sleep quality, and daily life.
Participants:
Completed an 8-session exercise and self-massage program over 4 weeks (2 times each week).
Either practiced live with a physical therapist over video calls or followed recorded video exercises on their own at home.
Answered surveys about pain, sleep quality, and oral health before and after the 4-week program.
Had their mouth opening, jaw muscle sensitivity, and muscle activity tested before and after the program.
Detailed description
Bruxism is characterized by repetitive masticatory muscle activity leading to masticatory muscle pain, restricted mandibular range of motion, and impaired oral health-related quality of life. Telerehabilitation represents a promising alternative to conventional face-to-face physiotherapy to overcome accessibility barriers.
In this prospective, randomized, two-arm parallel-group controlled trial, individuals diagnosed with clinically-based bruxism were randomly assigned to either the Synchronous Telerehabilitation Group (S-TRG) or the Asynchronous Telerehabilitation Group (A-TRG).
Both groups completed an 8-session intervention protocol over 4 weeks (2 sessions per week). The intervention protocol comprised:
Breathing training protocol (deep diaphragmatic breathing), Cervical region stretching and chin-tuck exercises, Temporomandibular joint range of motion and stretching exercises, Bilateral self-massage techniques (sliding, kneading, friction, and ischemic compression to masseter and temporalis muscles), Scapular stabilization exercises (W, T, and Y exercises).
In the S-TRG, sessions were conducted in real time under the direct supervision of a physiotherapist via live video calls. In the A-TRG, participants were taught the exercises in an initial recorded live video session and subsequently performed the protocol independently using their personalized instructional video recordings, with weekly phone/text check-ins to monitor adherence and screen for adverse events. Additionally, all participants received a standardized patient education brochure on TMJ care and behavioral modifications.
Outcome assessments were conducted at baseline and immediately following the 4-week intervention period. Evaluated parameters included:
Pain intensity assessed using the 0-10 Numeric Rating Scale (NRS) at rest, during the night, in the morning, and during activity, Maximum mouth opening (MMO) measured with a caliper, Pressure pain threshold (PPT) and pressure pain tolerance (PPTol) of the masseter and temporalis anterior muscles assessed using a digital algometer, Masticatory muscle activation during maximum voluntary isometric contraction and clenching tasks assessed via surface electromyography (sEMG), Oral health-related quality of life evaluated using the 14-item Oral Health Impact Profile (OHIP-14), Subjective sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized into two parallel groups: Synchronous Telerehabilitation Group (S-TRG) or Asynchronous Telerehabilitation Group (A-TRG).
| Arm | Type | Receives |
|---|---|---|
| Synchronous Telerehabilitation Group (S-TRG) | Experimental | Behavioral: Synchronous Telerehabilitation ProtocolParticipants completed an 8-session therapeutic exercise and self-massage program over 4 weeks (2 sessions per week) via real-time live video calls under the direct supervision of a physiotherapist. They also received TMJ patient education and behavioral modification brochures. |
| Asynchronous Telerehabilitation Group (A-TRG) | Active comparator | Behavioral: Asynchronous Telerehabilitation ProtocolParticipants were taught the same 8-session exercise and self-massage protocol in an initial live recorded video session and subsequently performed the exercises independently at home for 4 weeks using personalized video recordings, supported by weekly check-ins. They also received TMJ patient education and behavioral modification brochures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with clinically-based bruxism
- Aged 18 years or older
- Voluntarily agreed to participate and provided written informed consent
Key exclusion criteria (10 listed)
- Prior or concurrent neurological, psychiatric, or systemic diseases
- Ongoing dental treatment
- Currently receiving physical therapy
- Regular use of medications such as analgesics or muscle relaxants
- History of surgery or trauma involving the temporomandibular joint (TMJ) or neck region
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 |
|---|---|---|
| Synchronous Telerehabilitation ProtocolReal-time video-supervised protocol consisting of diaphragmatic breathing, cervical stretching, TMJ range of motion and self-stretching, bilateral masseter/temporalis self-massage, scapular stabilization exercises, and TMJ education brochure (8 sessions over 4 weeks). | Behavioural | Synchronous Telerehabilitation Group (S-TRG) |
| Asynchronous Telerehabilitation ProtocolVideo-recorded home protocol consisting of identical diaphragmatic breathing, cervical stretching, TMJ range of motion/self-stretching, bilateral self-massage, scapular exercises, and TMJ education brochure performed independently with weekly check-ins (8 sessions over 4 weeks). | Behavioural | Asynchronous Telerehabilitation Group (A-TRG) |
Primary outcome
Change in Pain Intensity
Time frame: Baseline and post-intervention (Week 4)
Assessed using the Numeric Rating Scale (NRS), an 11-point scale ranging from 0 (no pain) to 10 (worst possible pain). Pain intensity is evaluated at rest, during the night, in the morning upon waking, and during jaw activity/function.
6 secondary outcomes
Change in Maximum Mouth Opening (MMO)
Time frame: Baseline and post-intervention (Week 4)
Change in Pressure Pain Threshold (PPT)
Time frame: Baseline and post-intervention (Week 4)
Change in Pressure Pain Tolerance (PPTol)
Time frame: Baseline and post-intervention (Week 4)
Change in Masticatory Muscle Activity (sEMG)
Time frame: Baseline and post-intervention (Week 4)
Change in Oral Health-Related Quality of Life (OHIP-14)
Time frame: Baseline and post-intervention (Week 4)
Change in Subjective Sleep Quality (PSQI)
Time frame: Baseline and post-intervention (Week 4)
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 18 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Bruxism
RecruitingObservational study
Movement of Dental Implants During Osseointegration
Dental Implants, Osseointegration
Enrolling by invitationObservational study
The General Aim is to Implement Clinical Assessment of Overload by Voluntary Bite Force Registration to Enable Future Simple But Precise Risk Assessment to Provide Individualized Treatment Plans.
Dental Implant, Bruxism
Not yet recruiting
Influence Of Different Relaxation Techniques On Stress Level For Patients With Bruxism Using Salivary Biomarkers.
Bruxism, Stress (Psychology)
Not yet recruitingEarly Phase 1
Botulinum Toxin-A for Bruxism Using Digital Occlusal Analysis
Bruxism
RecruitingObservational study
Orofacial Pain and Oral Health-Related Quality of Life in Musicians in German Amateur Orchestras
Orofacial Pain, Sleep Bruxism
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.
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 Synchronous Telerehabilitation Protocol and Asynchronous Telerehabilitation Protocol in people with Bruxism and Sleep Bruxism, run by Gazi 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 3 inclusion and 10 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 18 Sep 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?
Change in Pain Intensity (time frame: Baseline and post-intervention (Week 4)). 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 18 Sep 2026; AzTrials last refreshed its copy on 31 Oct 2026.