BruxismNCT07058311
Evaluation of the Effects of Physiotherapy and Rehabilitation Interventions in Patients With Bruxism
A study testing Manual Therapy and Home Exercise Therapy in people with Bruxism and Physiotherapy, run by Bartın Unıversity at 1 site in Turkey (Türkiye).
Trial summary
Bruxism is a multifactorial condition that affects the masticatory muscles and often requires multidisciplinary management. This study aimed to investigate and compare the effects of manual therapy and home exercise on pain intensity, number of myofascial trigger points, temporomandibular joint (TMJ) and cervical… Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Bruxism, Physiotherapy, Exercise
- What is being tested?
- Manual Therapy and Home Exercise 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 Dec 2022to 1 Apr 2025
- 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 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Volunteer students aged between 18-25
- Answered "yes" to at least two of the six questions in the Bruxism questionnaire.
- Is there anyone hear you grinding your teeth at night? Do you feel fatigue or pain in your jaw when you wake up in the morning? Do you feel pain in your teeth and gums when you wake up in the morning? Do you have a headache when you wake up in the morning? Do you notice that you grind your teeth during the day? Do you notice that you clench your teeth during the day?
- -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,
- Having more than two molar teeth missing in the posterior
- Individuals who cannot cooperate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bartın University, Health Services Vocational School
Bartın
About this study
Bruxism is a multifactorial condition that affects the masticatory muscles and often requires multidisciplinary management. This study aimed to investigate and compare the effects of manual therapy and home exercise on pain intensity, number of myofascial trigger points, temporomandibular joint (TMJ) and cervical mobility, head posture, muscle thickness, stiffness, and activity in individuals with bruxism.
Methods: Thirty individuals diagnosed with bruxism were randomly assigned to two intervention groups: the Home Exercise Group (HEG) and the Manual Therapy Group (MTG). All participants received education about bruxism. The HEG performed a supervised home-based exercise program three times per week for eight weeks, supported by instructional videos and weekly follow-up. The MTG received intraoral and extraoral manual therapy targeting the jaw and cervical regions twice a week over the same period. Pain intensity (Visual Analog Scale), trigger point count (palpation), TMJ mobility (ruler), head posture and cervical mobility (goniometer), muscle thickness and stiffness (ultrasound), and muscle activity (electromyography) were evaluated before and after treatment.
- Conditions
- Bruxism, Physiotherapy, Exercise, Manual Theapy, Pain
- Being tested
- Manual Therapy, Home Exercise Therapy
- Keywords
- Bruxism, Manual Therapy, Exercise, Ultrasonography, Electromyography, physiotherapy
- Medical subject headings
- Bruxism, Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual TherapyOther
Various soft tissue and joint mobilizations, intramuscular stretches, trigger point treatments, and intraoral applications for the temporomandibular joint were performed in 15 randomly selected bruxism patients. Manual therapy was applied twice weekly over eight weeks, each session lasting approximately 45 minutes. Techniques included trigger point therapy, myofascial release, intraoral mobilizations to the masseter, medial and lateral pterygoid, and temporalis tendons, post-isometric relaxation for masticatory muscles, cervical traction, and suboccipital and cervical fascial release. The manual therapy procedure, which was applied in the supine position and lasted approximately 40 minutes for 8 weeks
Home Exercise TherapyOther
The exercise group consisted of 15 randomly selected bruxist individuals and aimed to reduce pain, decrease involuntary contractions of masticatory muscles, increase their nutrition, flexibility and coordination, and strengthen weak muscles with exercise therapy. The exercise program included Rocabado exercises, stretching of the platysma, masticatory and cervical muscles, resistance training (mouth opening, protrusion, and lateral mandibular movements), and postural exercises. Exercises were performed while sitting in a chair with back support in front of a mirror. Each exercise was repeated 10 times. The duration of each session was 25-30 minutes. repeat the home exercises three times a week for 8 weeks. Weekly phone calls were made to encourage compliance. In addition, a video explaining the exercises in detail was shared with all participants in the group in order to ensure that the exercises were not forgotten and to achieve accuracy and standardization among the participants.
| Study group | Role | What they receive |
|---|---|---|
| Manual Therapy Group | Experimental | The term manual therapy includes a wide variety of detailed applications ranging from joint-oriented applications (joint mobilizations and/or manipulations) or soft tissue techniques (muscle stretching or trigger point therapy) to therapeutic exercises. Manual therapy in our study was used to restore normal temporomandibular joint range of motion, reduce local ischemia, stimulate proprioception, break fibrous adhesions, stimulate synovial fluid production and reduce pain. Receives: Other: Manual Therapy |
| Exercise Group | Experimental | Exercise therapy, one of the physical therapy applications, has an important place in the rehabilitation of musculoskeletal disorders. With this method, it is aimed to decrease inflammation, increase coordination of muscle activity, promote tissue repair and regeneration, relieve pain and restore normal function. In addition to the special exercises known as Rocabado exercises which are used in the treatment of temporomandibular joint, various studies have been performed in which mobilization, coordination, posture and relaxation exercises were used for the treatment of disorders related to the masticatory system and it has been emphasized that studies on this subject should be continued. Receives: Other: Home Exercise Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Level
Visual analog scale (VAS) was used to assess the severity of pain related to bruxism. On a 10 cm long horizontal line, "0 (no pain)" was written at the beginning and "10 (most intense pain)" was written at the end and the patient was asked to mark the pain intensity they perceived at rest, active use and at night on the line. The pain intensity of the individual was recorded by measuring the distance marked on the line in millimeters. It has been reported that the Turkish version of the VAS is a valid and reliable measurement tool in the evaluation of musculoskeletal disorders
Measured: From baseline to the end of treatment at 8 weeks
Cervical and Temporomandibular Joint Range of Motion (ROM)
Cervical flexion, extension, lateral flexion, and rotation were measured using a universal goniometer. TMJ range of motion, including maximum mouth opening, protrusion, retrusion, and lateral excursions, was measured using a ruler.
Measured: From baseline to the end of the treatment at 8 weeks
Ultrasonographic Imaging
Ultrasound and elastography measurements were performed using the ACUSON S 2000 system (Siemens, Munich, Germany) by a single experienced radiologist. A 4-9 MHz linear transducer was used to measure the thickness and elasticity of the masseter, anterior temporalis, and SCM muscles both at rest and during maximal clenching, in a semi-recumbent position with head support. Measurements were recorded in millimeters
Measured: From baseline to the end of treatment at 8 weeks
Electromyography (EMG)
Surface EMG recordings were obtained using an 8-channel EMG system (BioResearch Inc., Milwaukee, Wisconsin, USA). Self-adhesive disposable surface electrodes were placed bilaterally over the masseter, anterior temporalis, and SCM muscles, with a grounding electrode on the trapezius. Electrodes were aligned parallel to muscle fibers at the muscle belly. Measurements were conducted in a quiet, dimly lit room, with participants seated in the Frankfurt Horizontal Plane position. Participants were asked to clench their teeth three times and then relax. Each EMG recording lasted 10 seconds and was repeated twice. From each 10-second recording, three 2-second segments from the first 6 seconds were selected, and the average EMG activity was calculated.
Measured: From baseline to the end of treatment at 8 weeks
Secondary outcomes (3)
Trigger Point
While evaluating the trigger points in the masticatory and neck muscles, the tense muscle was palpated with a fingertip. Palpation was performed along the long axis of the tense muscle and the most sensitive point was determined. 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. Evaluation was performed in 14 muscles (masseter, temporalis, suprahyoid, sternocleidomastoid (SCM), scalene, and suboccipital muscles) and the muscles with trigger points and the total number of trigger points were recorded.
Measured: From baseline to the end of treatment at 8 weeks
Presence and severity of Temporomandibular Joint Disorder (TMD) symptoms
It was examined with Fonseca Anamnestic Index (FAI). The Fonseca Anamnestic Index, a 10-question questionnaire designed to assess temporomandibular dysfunction (TMD), was administered. Responses included "No (0 points)," "Sometimes (5 points)," and "Yes (10 points)." The total score was calculated to quantify the severity of TMD. A high score means that the disorder is severe.
Measured: From baseline to the end of treatment at 8 weeks
Bruxism
It was examined with Bruxism Questionnaire. According to the survey questions prepared by referencing the studies of Pintado, 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. A high score means that the disorder is severe.
Measured: From baseline to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start1 Dec 2022
- Primary completion1 Oct 2023
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 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 Home Exercise Group (15).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bartın Unıversity
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miraç Sezer, Bartın Unıversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058311
- Sponsor's protocol ID
- 2022-1166
- Status last verified
- Sep 2025
- First submitted
- 9 May 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investgators can share the questionnaires and indexes used in the study
Publications
Bayhan MS, Kadioglu MB, Evli̇ C, Akat B, Kadioglu M, Orhan K, Elbasan B. Manual therapy versus home exercise in the treatment of bruxism: a randomized controlled trial with ultrasonographic, elastographic, and electromyographic assessment. BMC Oral Health. 2026 Aug 8;26(1):2184. doi: 10.1186/s12903-026-09472-3.
PubMed 42983785
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Physiotherapy and Rehabilitation Interventions in Patients With Bruxism
- ClinicalTrials.gov ID
- NCT07058311
- Acronym / sponsor ID
- 2022-1166
- Conditions
- Bruxism, Physiotherapy, Exercise, Manual Theapy, Pain
- Keywords
- Bruxism, Manual Therapy, Exercise, Ultrasonography, Electromyography, physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bartın UnıversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 10 Jul 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 is a multifactorial condition that affects the masticatory muscles and often requires multidisciplinary management. This study aimed to investigate and compare the effects of manual therapy and home exercise on pain intensity, number of myofascial trigger points, temporomandibular joint (TMJ) and cervical mobility, head posture, muscle thickness, stiffness, and activity in individuals with bruxism.
Methods: Thirty individuals diagnosed with bruxism were randomly assigned to two intervention groups: the Home Exercise Group (HEG) and the Manual Therapy Group (MTG). All participants received education about bruxism. The HEG performed a supervised home-based exercise program three times per week for eight weeks, supported by instructional videos and weekly follow-up. The MTG received intraoral and extraoral manual therapy targeting the jaw and cervical regions twice a week over the same period. Pain intensity (Visual Analog Scale), trigger point count (palpation), TMJ mobility (ruler), head posture and cervical mobility (goniometer), muscle thickness and stiffness (ultrasound), and muscle activity (electromyography) were evaluated before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Thirty patients with bruxism were randomly divided into as Manual Therapy Group (15) and Home Exercise Group (15).
| Arm | Type | Receives |
|---|---|---|
| Manual Therapy Group | Experimental | Other: Manual TherapyThe term manual therapy includes a wide variety of detailed applications ranging from joint-oriented applications (joint mobilizations and/or manipulations) or soft tissue techniques (muscle stretching or trigger point therapy) to therapeutic exercises. Manual therapy in our study was used to restore normal temporomandibular joint range of motion, reduce local ischemia, stimulate proprioception, break fibrous adhesions, stimulate synovial fluid production and reduce pain. |
| Exercise Group | Experimental | Other: Home Exercise TherapyExercise therapy, one of the physical therapy applications, has an important place in the rehabilitation of musculoskeletal disorders. With this method, it is aimed to decrease inflammation, increase coordination of muscle activity, promote tissue repair and regeneration, relieve pain and restore normal function. In addition to the special exercises known as Rocabado exercises which are used in the treatment of temporomandibular joint, various studies have been performed in which mobilization, coordination, posture and relaxation exercises were used for the treatment of disorders related to the masticatory system and it has been emphasized that studies on this subject should be continued. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Volunteer students aged between 18-25
- Answered "yes" to at least two of the six questions in the Bruxism questionnaire.
- Is there anyone hear you grinding your teeth at night? Do you feel fatigue or pain in your jaw when you wake up in the morning? Do you feel pain in your teeth and gums when you wake up in the morning? Do you have a headache when you wake up in the morning? Do you notice that you grind your teeth during the day? Do you notice that you clench your teeth during the day?
- -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 (6 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,
- Having more than two molar teeth missing in the posterior
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 TherapyVarious soft tissue and joint mobilizations, intramuscular stretches, trigger point treatments, and intraoral applications for the temporomandibular joint were performed in 15 randomly selected bruxism patients. Manual therapy was applied twice weekly over eight weeks, each session lasting approximately 45 minutes. Techniques included trigger point therapy, myofascial release, intraoral mobilizations to the masseter, medial and lateral pterygoid, and temporalis tendons, post-isometric relaxation for masticatory muscles, cervical traction, and suboccipital and cervical fascial release. The manual therapy procedure, which was applied in the supine position and lasted approximately 40 minutes for 8 weeks | Other | Manual Therapy Group |
| Home Exercise TherapyThe exercise group consisted of 15 randomly selected bruxist individuals and aimed to reduce pain, decrease involuntary contractions of masticatory muscles, increase their nutrition, flexibility and coordination, and strengthen weak muscles with exercise therapy. The exercise program included Rocabado exercises, stretching of the platysma, masticatory and cervical muscles, resistance training (mouth opening, protrusion, and lateral mandibular movements), and postural exercises. Exercises were performed while sitting in a chair with back support in front of a mirror. Each exercise was repeated 10 times. The duration of each session was 25-30 minutes. repeat the home exercises three times a week for 8 weeks. Weekly phone calls were made to encourage compliance. In addition, a video explaining the exercises in detail was shared with all participants in the group in order to ensure that the exercises were not forgotten and to achieve accuracy and standardization among the participants. | Other | Exercise Group |
Primary outcome
Pain Level
Time frame: From baseline to the end of treatment at 8 weeks
Visual analog scale (VAS) was used to assess the severity of pain related to bruxism. On a 10 cm long horizontal line, "0 (no pain)" was written at the beginning and "10 (most intense pain)" was written at the end and the patient was asked to mark the pain intensity they perceived at rest, active use and at night on the line. The pain intensity of the individual was recorded by measuring the distance marked on the line in millimeters. It has been reported that the Turkish version of the VAS is a valid and reliable measurement tool in the evaluation of musculoskeletal disorders
Cervical and Temporomandibular Joint Range of Motion (ROM)
Time frame: From baseline to the end of the treatment at 8 weeks
Cervical flexion, extension, lateral flexion, and rotation were measured using a universal goniometer. TMJ range of motion, including maximum mouth opening, protrusion, retrusion, and lateral excursions, was measured using a ruler.
Ultrasonographic Imaging
Time frame: From baseline to the end of treatment at 8 weeks
Ultrasound and elastography measurements were performed using the ACUSON S 2000 system (Siemens, Munich, Germany) by a single experienced radiologist. A 4-9 MHz linear transducer was used to measure the thickness and elasticity of the masseter, anterior temporalis, and SCM muscles both at rest and during maximal clenching, in a semi-recumbent position with head support. Measurements were recorded in millimeters
Electromyography (EMG)
Time frame: From baseline to the end of treatment at 8 weeks
Surface EMG recordings were obtained using an 8-channel EMG system (BioResearch Inc., Milwaukee, Wisconsin, USA). Self-adhesive disposable surface electrodes were placed bilaterally over the masseter, anterior temporalis, and SCM muscles, with a grounding electrode on the trapezius. Electrodes were aligned parallel to muscle fibers at the muscle belly. Measurements were conducted in a quiet, dimly lit room, with participants seated in the Frankfurt Horizontal Plane position. Participants were asked to clench their teeth three times and then relax. Each EMG recording lasted 10 seconds and was repeated twice. From each 10-second recording, three 2-second segments from the first 6 seconds were selected, and the average EMG activity was calculated.
3 secondary outcomes
Trigger Point
Time frame: From baseline to the end of treatment at 8 weeks
Presence and severity of Temporomandibular Joint Disorder (TMD) symptoms
Time frame: From baseline to the end of treatment at 8 weeks
Bruxism
Time frame: From baseline to the end of treatment at 8 weeks
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 10 Sep 2025.
- Derived from this study: PubMed 42983785Bayhan MS, Kadioglu MB, Evli̇ C, Akat B, Kadioglu M, Orhan K, Elbasan B. Manual therapy versus home exercise in the treatment of bruxism: a randomized controlled trial with ultrasonographic, elastographic, and electromyographic assessment. BMC Oral Health. 2026 Aug 8;26(1):2184. doi: 10.1186/s12903-026-09472-3.
- Individual participant dataSharing planned: Yes. Investgators 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. 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 Manual Therapy and Home Exercise 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 4 inclusion and 6 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 10 Sep 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?
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?
Pain Level (time frame: From baseline to the end of treatment at 8 weeks). 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 NCT07058311, which also lists 1 linked publication.
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 10 Sep 2025.