BruxismNCT06450782
The Effect of PIR and MRT on Muscle Stiffness and Pain in Individuals With Bruxism
A study testing Post-isometric Relaxation Technique and Myofascial Release Technique in people with Bruxism and Post-isometric Relaxation Technique, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
Bruxism is a repetitive jaw muscle activity that occurs during sleep or while awake, characterized by teeth clenching or grinding. Bruxism affects millions of people worldwide and is considered one of the most harmful activities for the stomatognathic system due to its morphological, pathophysiological, psychosocial… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bruxism, Post-isometric Relaxation Technique, Myofascial Release Technique
- What is being tested?
- Post-isometric Relaxation Technique and Myofascial Release Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2024to 15 Oct 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being diagnosed with bruxism Being willing and volunteer to work
Who cannot join
- Having a neurological, psychiatric or systemic disease Being addicted to alcohol and drugs Getting dental treatment or physical therapy Using an occlusal splint being pregnant actively having cancer Planning surgery for relevant areas Not having more than two molars Using removable dentures Receiving treatment for the temporomandibular joint in the last three months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yunus Emre TÜTÜNEKEN
Istanbul, Zeytinburnu, 34010
About this study
Official title: The Effect of Post-Isometric Relaxation Technique and Myofascial Relaxation Technique on Muscle Stiffness and Pain in Individuals With Bruxism
Bruxism is a repetitive jaw muscle activity that occurs during sleep or while awake, characterized by teeth clenching or grinding. Bruxism affects millions of people worldwide and is considered one of the most harmful activities for the stomatognathic system due to its morphological, pathophysiological, psychosocial features and clinical consequences. Repetitive teeth clenching and grinding movements can cause spasms, stiffness, pain, and activity changes in the chewing muscles. Since bruxism is a disorder that depends on many variables, there is no single, specific treatment and multidisciplinary approaches are often required. Most treatment strategies are conservative and symptomatic, aiming to prevent the consequences of the disorder. The main purpose of physiotherapy techniques is to reduce the negative effects of bruxism on the chewing system. Physiotherapy techniques include exercises, manual therapy, electrotherapy, acupuncture, and posture awareness. It is not clear in the literature which physiotherapy techniques are effective in the management of bruxism; Therefore, more controlled studies need to be conducted. When studies in the literature are examined, no studies have been found that objectively investigate the effectiveness of relaxation techniques alone in people with muscle pain and increased muscle stiffness due to teeth clenching problems. Within the scope of this project, it is planned to investigate the effectiveness of the myofascial release technique (MRT) and post-isometric relaxation technique (PİRT) using the grastone tool.
Read the detailed description
Bruxism is a repetitive jaw muscle activity that occurs during sleep or while awake, characterized by teeth clenching or grinding. Bruxism affects millions of people worldwide and is considered one of the most harmful activities for the stomatognathic system due to its morphological, pathophysiological, psychosocial features and clinical consequences. Repetitive teeth clenching and grinding movements can cause spasms, stiffness, pain, and activity changes in the chewing muscles. Since bruxism is a disorder that depends on many variables, there is no single, specific treatment and multidisciplinary approaches are often required. Most treatment strategies are conservative and symptomatic, aiming to prevent the consequences of the disorder. The main purpose of physiotherapy techniques is to reduce the negative effects of bruxism on the chewing system. Physiotherapy techniques include exercises, manual therapy, electrotherapy, acupuncture, and posture awareness. It is not clear in the literature which physiotherapy techniques are effective in the management of bruxism; Therefore, more controlled studies need to be conducted. When studies in the literature are examined, no studies have been found that objectively investigate the effectiveness of relaxation techniques alone in people with muscle pain and increased muscle stiffness due to teeth clenching problems. Within the scope of this project, it is planned to investigate the effectiveness of the myofascial release technique (MGT) and post-isometric relaxation technique (PGT) using the grastone tool. MGT provides pain relief and functional recovery by creating a low load and long-term stretching effect on the myofascial structure. Post-isometric relaxation technique (PGT), a muscle energy technique, involves voluntary contraction in a precisely controlled direction against resistance. The results of this study will reveal the effects of MGT and PGT, which have different mechanisms of action, on muscle stiffness and pain in people with bruxism. In addition, by analyzing and presenting the data obtained, the gap in the current literature will be filled and it will contribute to becoming a component of the frequently used physiotherapy program in the management of bruxism. It is expected that patients' quality of life and productivity will increase depending on the relief of their symptoms. The study is a prospective, randomized, controlled, double-blind study. People with bruxism will be informed about the study and an informed consent form will be obtained. Participants' age, gender, body weight, height and Body Mass Index (BMI) will be evaluated and recorded with a specially prepared evaluation form. Individuals with bruxism between the ages of 18-65 who volunteer to participate in the study will be included. The study included patients with neurological, psychiatric, or systemic disease, dental treatment or physical therapy, using occlusal splints, being pregnant and having active cancer, having surgery planned for the relevant areas, having no more than two molars, using removable prostheses, and those using temporomandibular joint in the last three months. People receiving treatment will be excluded. Participants will be randomly divided into three groups. Participants will be assigned to the MGT group, PGT group, and Control group. In our study, MyotonPRO will be used to evaluate the stiffness of the sternocleidomastoid and masseter muscles of bruxism patients and the visual analog scale will be used to evaluate pain. All evaluations will be made by the same researcher before and immediately after the single-session intervention. No intervention will be made to the chin and cervical area before the first measurement. There will be a 2-minute break before the second evaluation begins.
- Being tested
- Post-isometric Relaxation Technique, Myofascial Release Technique, Control
- Medical subject headings
- Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-isometric Relaxation TechniqueOther
Sternocleidomastoid muscle Participants are asked to stretch their necks in a spuni position and then turn their heads as far to the side of the target muscle (right side) as possible until a sensation occurs that causes discomfort in the targeted SCM. In this case, the participants are asked to moderately isometrically contract the SKM muscle for 5 seconds and then relax for 3 seconds and the cervical spine is moved to the new barrier.
Masseter muscle Participants are positioned in a sitting position. The jaw is opened as wide as possible. The index and middle fingers of one hand are placed over the lower teeth. The weight of the hand is allowed to provide flexion and traction is applied directly to the midline. In this case, the participants are asked to moderately isometrically contract the bilateral masseter muscles for 5 seconds, then relax for 3 seconds and the participant moves his chin to the new barrier.
Myofascial Release TechniqueOther
Sternocleidomastoid muscle The head is slightly elevated with the help of a folded towel to prevent discomfort that may develop depending on the position. The researcher sits in a chair next to the participant's head. The chair is placed at approximately 45° to the participant's neck. The participant's head is rotated 30° towards the opposite side of the treated side. The Graston instrument contacts the upper part of the SCM approximately 2 cm below the mastoid process.
Masseter muscle It works both ways. The Graston instrument is placed on the zygomatic process of the temporal bone, approximately 1 cm in front of the ear. The soft tissue is pressed until the bone is contacted. This connection with the periosteum is maintained and a lower tension line is created towards the mandible angle. This line of tension is continued up to the mandible, where the periosteum also comes into play. It is repeated several times.
ControlOther
Participants will rest for thirty minutes.
| Study group | Role | What they receive |
|---|---|---|
| PIR Group | Experimental | Participants in the PIR Group will apply one session of post-isometric relaxation technique. Receives: Other: Post-isometric Relaxation Technique; Other: Control |
| MR Grup | Experimental | Participants in the MR Group will apply one session of myofascial release technique. Receives: Other: Myofascial Release Technique |
| Control Group | No intervention | No intervention will be made to the participants in the Control Group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Stiffness
MyotonPRO (Muomeetria Ltd., Tallinn, Estonia) will be used to measure the stiffness of the muscles. This device works by producing a mechanical impulse on the skin over the muscle being measured. Mechanical oscillations of muscles created by mechanical impulses are measured by MyotonPRO. Muscle stiffness is measured in Newtons per meter (N/m). This method can determine the muscle's resistance to deforming forces or muscle stiffness.
In the study, measurements will be made at room temperature at approximately 25°C, and after the participants sit on a chair for 5 minutes. During the measurement, participants will be asked to contact the SCM and masseter muscles with maximum force, and the most prominent location of the muscles will be marked. The stiffness of both muscles will be measured in both relaxed and maximum contraction conditions. All measurements will be taken 3 times and their averages will be calculated.
Measured: 1 Day
Pain Intensity
For pain intensity according to VAS, "no pain" is usually rated as 0 points and "worst pain imaginable" as 10 points (10 cm scale). Ranges for pain intensity; <3 is mild pain, 3-6 is moderate pain, >6 is severe pain.
Measured: 1 Day
Secondary outcomes (1)
Range Of Montion
A caliper will be used for maximum mouth opening and a linear ruler will be used for slides. For maximal mouth opening, the patient will be asked to open his mouth as much as he can, the movement is repeated three times, and when the mouth is opened for the third time, the distance between the lower and upper incisors will be measured and recorded.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start15 Jun 2024
- Primary completion15 Aug 2024
- Study completion15 Oct 2024
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.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunus Emre Tutuneken, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450782
- Sponsor's protocol ID
- 13
- Status last verified
- Apr 2025
- First submitted
- 5 Jun 2024
- Last updated
- 17 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Post-Isometric Relaxation Technique and Myofascial Relaxation Technique on Muscle Stiffness and Pain in Individuals With Bruxism
- ClinicalTrials.gov ID
- NCT06450782
- Acronym / sponsor ID
- 13
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 10 Jun 2024 (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 that occurs during sleep or while awake, characterized by teeth clenching or grinding. Bruxism affects millions of people worldwide and is considered one of the most harmful activities for the stomatognathic system due to its morphological, pathophysiological, psychosocial features and clinical consequences. Repetitive teeth clenching and grinding movements can cause spasms, stiffness, pain, and activity changes in the chewing muscles. Since bruxism is a disorder that depends on many variables, there is no single, specific treatment and multidisciplinary approaches are often required. Most treatment strategies are conservative and symptomatic, aiming to prevent the consequences of the disorder. The main purpose of physiotherapy techniques is to reduce the negative effects of bruxism on the chewing system. Physiotherapy techniques include exercises, manual therapy, electrotherapy, acupuncture, and posture awareness. It is not clear in the literature which physiotherapy techniques are effective in the management of bruxism; Therefore, more controlled studies need to be conducted. When studies in the literature are examined, no studies have been found that objectively investigate the effectiveness of relaxation techniques alone in people with muscle pain and increased muscle stiffness due to teeth clenching problems. Within the scope of this project, it is planned to investigate the effectiveness of the myofascial release technique (MRT) and post-isometric relaxation technique (PİRT) using the grastone tool.
Detailed description
Bruxism is a repetitive jaw muscle activity that occurs during sleep or while awake, characterized by teeth clenching or grinding. Bruxism affects millions of people worldwide and is considered one of the most harmful activities for the stomatognathic system due to its morphological, pathophysiological, psychosocial features and clinical consequences. Repetitive teeth clenching and grinding movements can cause spasms, stiffness, pain, and activity changes in the chewing muscles. Since bruxism is a disorder that depends on many variables, there is no single, specific treatment and multidisciplinary approaches are often required. Most treatment strategies are conservative and symptomatic, aiming to prevent the consequences of the disorder. The main purpose of physiotherapy techniques is to reduce the negative effects of bruxism on the chewing system. Physiotherapy techniques include exercises, manual therapy, electrotherapy, acupuncture, and posture awareness. It is not clear in the literature which physiotherapy techniques are effective in the management of bruxism; Therefore, more controlled studies need to be conducted. When studies in the literature are examined, no studies have been found that objectively investigate the effectiveness of relaxation techniques alone in people with muscle pain and increased muscle stiffness due to teeth clenching problems. Within the scope of this project, it is planned to investigate the effectiveness of the myofascial release technique (MGT) and post-isometric relaxation technique (PGT) using the grastone tool. MGT provides pain relief and functional recovery by creating a low load and long-term stretching effect on the myofascial structure. Post-isometric relaxation technique (PGT), a muscle energy technique, involves voluntary contraction in a precisely controlled direction against resistance. The results of this study will reveal the effects of MGT and PGT, which have different mechanisms of action, on muscle stiffness and pain in people with bruxism. In addition, by analyzing and presenting the data obtained, the gap in the current literature will be filled and it will contribute to becoming a component of the frequently used physiotherapy program in the management of bruxism. It is expected that patients' quality of life and productivity will increase depending on the relief of their symptoms. The study is a prospective, randomized, controlled, double-blind study. People with bruxism will be informed about the study and an informed consent form will be obtained. Participants' age, gender, body weight, height and Body Mass Index (BMI) will be evaluated and recorded with a specially prepared evaluation form. Individuals with bruxism between the ages of 18-65 who volunteer to participate in the study will be included. The study included patients with neurological, psychiatric, or systemic disease, dental treatment or physical therapy, using occlusal splints, being pregnant and having active cancer, having surgery planned for the relevant areas, having no more than two molars, using removable prostheses, and those using temporomandibular joint in the last three months. People receiving treatment will be excluded. Participants will be randomly divided into three groups. Participants will be assigned to the MGT group, PGT group, and Control group. In our study, MyotonPRO will be used to evaluate the stiffness of the sternocleidomastoid and masseter muscles of bruxism patients and the visual analog scale will be used to evaluate pain. All evaluations will be made by the same researcher before and immediately after the single-session intervention. No intervention will be made to the chin and cervical area before the first measurement. There will be a 2-minute break before the second evaluation begins.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PIR Group | Experimental | Other: Post-isometric Relaxation Technique, Other: ControlParticipants in the PIR Group will apply one session of post-isometric relaxation technique. |
| MR Grup | Experimental | Other: Myofascial Release TechniqueParticipants in the MR Group will apply one session of myofascial release technique. |
| Control Group | No intervention | –No intervention will be made to the participants in the Control Group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Being diagnosed with bruxism Being willing and volunteer to work
Key exclusion criteria (1 listed)
- Having a neurological, psychiatric or systemic disease Being addicted to alcohol and drugs Getting dental treatment or physical therapy Using an occlusal splint being pregnant actively having cancer Planning surgery for relevant areas Not having more than two molars Using removable dentures Receiving treatment for the temporomandibular joint in the last three months
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 |
|---|---|---|
| Post-isometric Relaxation TechniqueSternocleidomastoid muscle Participants are asked to stretch their necks in a spuni position and then turn their heads as far to the side of the target muscle (right side) as possible until a sensation occurs that causes discomfort in the targeted SCM. In this case, the participants are asked to moderately isometrically contract the SKM muscle for 5 seconds and then relax for 3 seconds and the cervical spine is moved to the new barrier. Masseter muscle Participants are positioned in a sitting position. The jaw is opened as wide as possible. The index and middle fingers of one hand are placed over the lower teeth. The weight of the hand is allowed to provide flexion and traction is applied directly to the midline. In this case, the participants are asked to moderately isometrically contract the bilateral masseter muscles for 5 seconds, then relax for 3 seconds and the participant moves his chin to the new barrier. | Other | PIR Group |
| Myofascial Release TechniqueSternocleidomastoid muscle The head is slightly elevated with the help of a folded towel to prevent discomfort that may develop depending on the position. The researcher sits in a chair next to the participant's head. The chair is placed at approximately 45° to the participant's neck. The participant's head is rotated 30° towards the opposite side of the treated side. The Graston instrument contacts the upper part of the SCM approximately 2 cm below the mastoid process. Masseter muscle It works both ways. The Graston instrument is placed on the zygomatic process of the temporal bone, approximately 1 cm in front of the ear. The soft tissue is pressed until the bone is contacted. This connection with the periosteum is maintained and a lower tension line is created towards the mandible angle. This line of tension is continued up to the mandible, where the periosteum also comes into play. It is repeated several times. | Other | MR Grup |
| ControlParticipants will rest for thirty minutes. | Other | PIR Group |
Primary outcome
Muscle Stiffness
Time frame: 1 Day
MyotonPRO (Muomeetria Ltd., Tallinn, Estonia) will be used to measure the stiffness of the muscles. This device works by producing a mechanical impulse on the skin over the muscle being measured. Mechanical oscillations of muscles created by mechanical impulses are measured by MyotonPRO. Muscle stiffness is measured in Newtons per meter (N/m). This method can determine the muscle's resistance to deforming forces or muscle stiffness. In the study, measurements will be made at room temperature at approximately 25°C, and after the participants sit on a chair for 5 minutes. During the measurement, participants will be asked to contact the SCM and masseter muscles with maximum force, and the most prominent location of the muscles will be marked. The stiffness of both muscles will be measured in both relaxed and maximum contraction conditions. All measurements will be taken 3 times and their averages will be calculated.
Pain Intensity
Time frame: 1 Day
For pain intensity according to VAS, "no pain" is usually rated as 0 points and "worst pain imaginable" as 10 points (10 cm scale). Ranges for pain intensity; <3 is mild pain, 3-6 is moderate pain, >6 is severe pain.
1 secondary outcome
Range Of Montion
Time frame: 1 Day
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 17 Apr 2025.
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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 Post-isometric Relaxation Technique and Myofascial Release Technique in people with Bruxism and Post-isometric Relaxation Technique, run by Istinye 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 1 inclusion and 1 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 17 Apr 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?
Muscle Stiffness (time frame: 1 Day). 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 17 Apr 2025.