BruxismNCT06573346
Cervical Stabilization Exercises on Bruxism and Sleep Quality
A study testing Cervical spinal stabilization exercise in people with Bruxism and Sleep Quality, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Bruxism and temporomandibular joint dysfunction are common conditions today. The applications in the treatment of these disorders are limited. When the literature is examined, it has been determined that cervical stabilization exercises, which are frequently applied in physical therapy clinics for neck problems, have… Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bruxism, Sleep Quality, Cervical Stabilization Exercise
- What is being tested?
- Cervical spinal stabilization exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Aug 2024to 20 Feb 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 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with full dentition including 2nd molars
- Patients without facial asymmetry
Who cannot join
- Patients with systemic and/or neuromuscular diseases
- Patients with orofacial pain not caused by bruxism
- History of temporomandibular joint (TMJ) surgery or injection
- Use of any medical drugs affecting the muscular system
- Patients with developmental deformities or a history of surgery in the maxillofacial region (facial trauma history, resection history, etc.)
- TMJ pathologies (major condylar changes seen on panoramic radiographs)
Show all 15Show fewer
- History of radiotherapy and/or chemotherapy
- Ongoing orthodontic treatment
- Use of removable prosthesis
- Inflammatory connective tissue diseases
- Pregnancy
- Obstructive sleep apnea
- Local skin infection over the myofascial area
- Patients who have undergone root canal treatment
- Reluctance to take responsibility for the work
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Kent University
Istanbul, Kağıthane, 34406
About this study
Official title: Investigation of the Effect of Cervical Stabilization Exercises on Bruxism and Sleep Quality
Bruxism and temporomandibular joint dysfunction are common conditions today. The applications in the treatment of these disorders are limited. When the literature is examined, it has been determined that cervical stabilization exercises, which are frequently applied in physical therapy clinics for neck problems, have not been applied to bruxism before. For this reason, in this study, we will examine the effects of cervical stabilization exercises targeting deep cervical muscles on bruxism.
Read the detailed description
Bruxism is the grinding or clenching of teeth, which is characterized by the fixed or forward movement of the mandible that occurs repeatedly during the day, including muscles such as the masseter and temporal muscles. Correct determination of the etiology plays a key role in the treatment of bruxism. There are many suggestions in the literature for the treatment of bruxism. The most preferred of these are: providing training for the person to quit harmful habits, physiotherapy applications for muscle relaxation, botox applications, drug treatments, giving the patient an occlusal splint, etc. Since bruxism is a functional problem of muscular origin, it is possible to talk about muscle-oriented exercise applications in its treatment. As a result of studies in which exercises are frequently prescribed for the chewing muscles and temporomandibular muscles, it has been determined that bruxism symptoms are relieved and functional gains are achieved. It has also been stated that muscle pain and activity, mouth opening, oral health, anxiety, stress, depression and head posture can be improved in individuals with bruxism with physiotherapy approaches. When the literature is examined; There are studies investigating the effects of physiotherapy applications in bruxism. In addition, although it is known that the neck region is affected in bruxism, causing the head to tilt forward and increased muscle activation in the neck region, no study has been found investigating the effects of specific cervical region stabilization exercises. This study was planned considering the effects of cervical stabilization exercises on correcting cervical posture and providing muscle activation balance.
- Conditions
- Bruxism, Sleep Quality, Cervical Stabilization Exercise
- Being tested
- Cervical spinal stabilization exercise
- Medical subject headings
- Bruxism, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical spinal stabilization exerciseOther
The cervical region is one of the most affected regions of the musculoskeletal system due to the intensive proprioceptors. Studies have shown that many position sense proprioceptors are over the deep group cervical muscles such as longus colitis and longus capitis. The deep group cervical muscles, which perform a dynamic ligament function, have an important role in maintaining the stability of the spine as well as the proprioceptive sense. In particular, proprioceptive receptors, which are commonly found in the deep suboccipital muscles; There are cervical and reflex connections with vestibular, visual and postural control systems.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Not described Receives: Other: Cervical spinal stabilization exercise |
| Experimental group | Experimental | Not described Receives: Other: Cervical spinal stabilization exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Activation Evaluation
Participants' Masseter, Temporal and Trapezius muscle activation will be evaluated with Superficial Electromyography. (Number of Participants estimated 28 individuals)
Measured: At baseline, after 6 weeks of treatment, 4 weeks after the end of treatment
Tongue Pressure Evaluation
Tongue pressure will be done by oral muscle measurement. (Number of Participants estimated 28 individuals)
Measured: At baseline, after 6 weeks of treatment, 4 weeks after the end of treatment
Evaluation of Sleep Quality
Since bruxism affects the sleep quality of patients, the Pittsburg Sleep Quality Index will be used to evaluate sleep quality. (Number of Participants estimated 28 individuals)
Measured: At baseline, after 6 weeks of treatment, 4 weeks after the end of treatment
Secondary outcomes (2)
Mouth Opening Evaluation
The amount of mouth opening will be evaluated by adding the vertical coverage amounts of the lower and upper incisors to the distance between the incisal edges of the lower and upper incisors at maximum mouth opening, using a ruler, for pre-treatment, post-treatment and 1 month later follow-up purposes. (Number of Participants estimated 28 individuals)
Measured: At baseline, after 6 weeks of treatment, 4 weeks after the end of treatment
Tongue Range of Motion Ratio Assessment
In the functional tongue tie classification published by Ferrés-Amat et al., the mouth opening with tongue tip to maxillary incisive papillae at roof of mouth (MOTTIP) and the maximum interincisal mouth opening (MIO) ratio (MOTTIP/MIO ratio is defined as "Tongue range of motion ratio - TRMR") will be used to measure functional tongue limitation. In this classification system, it is stated as Grade 1: tongue range of motion ratio >% 80, Grade 2: 50-80, Grade 3: <% 50, Grade 4: <% 25. (Number of Participants estimated 28 individuals)
Measured: At baseline, after 6 weeks of treatment, 4 weeks after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start30 Aug 2024
- Primary completion19 Feb 2025
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Necmettin Erbakan University
- Responsible party
- Principal investigator, Emine Nur Demircan, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573346
- Sponsor's protocol ID
- Cervical stabilization
- Status last verified
- Aug 2024
- First submitted
- 24 Aug 2024
- Last updated
- 3 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Lobbezoo F, Ahlberg J, Glaros AG, Kato T, Koyano K, Lavigne GJ, de Leeuw R, Manfredini D, Svensson P, Winocur E. Bruxism defined and graded: an international consensus. J Oral Rehabil. 2013 Jan;40(1):2-4. doi: 10.1111/joor.12011. Epub 2012 Nov 4.
PubMed 23121262Lavigne GJ, Kato T, Kolta A, Sessle BJ. Neurobiological mechanisms involved in sleep bruxism. Crit Rev Oral Biol Med. 2003;14(1):30-46. doi: 10.1177/154411130301400104.
PubMed 12764018Kato T, Rompre P, Montplaisir JY, Sessle BJ, Lavigne GJ. Sleep bruxism: an oromotor activity secondary to micro-arousal. J Dent Res. 2001 Oct;80(10):1940-4. doi: 10.1177/00220345010800101501.
PubMed 11706956Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771Hirai K, Ikawa T, Shigeta Y, Shigemoto S, Ogawa T. Evaluation of sleep bruxism with a novel designed occlusal splint. J Prosthodont Res. 2017 Jul;61(3):333-343. doi: 10.1016/j.jpor.2016.12.007. Epub 2017 Jan 18.
PubMed 28109797
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Cervical Stabilization Exercises on Bruxism and Sleep Quality
- ClinicalTrials.gov ID
- NCT06573346
- Acronym / sponsor ID
- Cervical stabilization
- Conditions
- Bruxism, Sleep Quality, Cervical Stabilization Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Necmettin Erbakan University
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- 19 Feb 2025 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 27 Aug 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 and temporomandibular joint dysfunction are common conditions today. The applications in the treatment of these disorders are limited. When the literature is examined, it has been determined that cervical stabilization exercises, which are frequently applied in physical therapy clinics for neck problems, have not been applied to bruxism before. For this reason, in this study, we will examine the effects of cervical stabilization exercises targeting deep cervical muscles on bruxism.
Detailed description
Bruxism is the grinding or clenching of teeth, which is characterized by the fixed or forward movement of the mandible that occurs repeatedly during the day, including muscles such as the masseter and temporal muscles. Correct determination of the etiology plays a key role in the treatment of bruxism. There are many suggestions in the literature for the treatment of bruxism. The most preferred of these are: providing training for the person to quit harmful habits, physiotherapy applications for muscle relaxation, botox applications, drug treatments, giving the patient an occlusal splint, etc. Since bruxism is a functional problem of muscular origin, it is possible to talk about muscle-oriented exercise applications in its treatment. As a result of studies in which exercises are frequently prescribed for the chewing muscles and temporomandibular muscles, it has been determined that bruxism symptoms are relieved and functional gains are achieved. It has also been stated that muscle pain and activity, mouth opening, oral health, anxiety, stress, depression and head posture can be improved in individuals with bruxism with physiotherapy approaches. When the literature is examined; There are studies investigating the effects of physiotherapy applications in bruxism. In addition, although it is known that the neck region is affected in bruxism, causing the head to tilt forward and increased muscle activation in the neck region, no study has been found investigating the effects of specific cervical region stabilization exercises. This study was planned considering the effects of cervical stabilization exercises on correcting cervical posture and providing muscle activation balance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: Cervical spinal stabilization exercise |
| Experimental group | Experimental | Other: Cervical spinal stabilization exercise |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with full dentition including 2nd molars
- Patients without facial asymmetry
Key exclusion criteria (15 listed)
- Patients with systemic and/or neuromuscular diseases
- Patients with orofacial pain not caused by bruxism
- History of temporomandibular joint (TMJ) surgery or injection
- Use of any medical drugs affecting the muscular system
- Patients with developmental deformities or a history of surgery in the maxillofacial region (facial trauma history, resection history, etc.)
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 |
|---|---|---|
| Cervical spinal stabilization exerciseThe cervical region is one of the most affected regions of the musculoskeletal system due to the intensive proprioceptors. Studies have shown that many position sense proprioceptors are over the deep group cervical muscles such as longus colitis and longus capitis. The deep group cervical muscles, which perform a dynamic ligament function, have an important role in maintaining the stability of the spine as well as the proprioceptive sense. In particular, proprioceptive receptors, which are commonly found in the deep suboccipital muscles; There are cervical and reflex connections with vestibular, visual and postural control systems. | Other | Control group, Experimental group |
Primary outcome
Muscle Activation Evaluation
Time frame: At baseline, after 6 weeks of treatment, 4 weeks after the end of treatment
Participants' Masseter, Temporal and Trapezius muscle activation will be evaluated with Superficial Electromyography. (Number of Participants estimated 28 individuals)
Tongue Pressure Evaluation
Time frame: At baseline, after 6 weeks of treatment, 4 weeks after the end of treatment
Tongue pressure will be done by oral muscle measurement. (Number of Participants estimated 28 individuals)
Evaluation of Sleep Quality
Time frame: At baseline, after 6 weeks of treatment, 4 weeks after the end of treatment
Since bruxism affects the sleep quality of patients, the Pittsburg Sleep Quality Index will be used to evaluate sleep quality. (Number of Participants estimated 28 individuals)
2 secondary outcomes
Mouth Opening Evaluation
Time frame: At baseline, after 6 weeks of treatment, 4 weeks after the end of treatment
Tongue Range of Motion Ratio Assessment
Time frame: At baseline, after 6 weeks of treatment, 4 weeks after the end of treatment
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 3 Jul 2025.
- Background: PubMed 23121262Lobbezoo F, Ahlberg J, Glaros AG, Kato T, Koyano K, Lavigne GJ, de Leeuw R, Manfredini D, Svensson P, Winocur E. Bruxism defined and graded: an international consensus. J Oral Rehabil. 2013 Jan;40(1):2-4. doi: 10.1111/joor.12011. Epub 2012 Nov 4.
- Background: PubMed 12764018Lavigne GJ, Kato T, Kolta A, Sessle BJ. Neurobiological mechanisms involved in sleep bruxism. Crit Rev Oral Biol Med. 2003;14(1):30-46. doi: 10.1177/154411130301400104.
- Background: PubMed 11706956Kato T, Rompre P, Montplaisir JY, Sessle BJ, Lavigne GJ. Sleep bruxism: an oromotor activity secondary to micro-arousal. J Dent Res. 2001 Oct;80(10):1940-4. doi: 10.1177/00220345010800101501.
- Background: PubMed 2748771Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- Background: PubMed 28109797Hirai K, Ikawa T, Shigeta Y, Shigemoto S, Ogawa T. Evaluation of sleep bruxism with a novel designed occlusal splint. J Prosthodont Res. 2017 Jul;61(3):333-343. doi: 10.1016/j.jpor.2016.12.007. Epub 2017 Jan 18.
- Individual participant dataSharing planned: Yes
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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 Cervical spinal stabilization exercise in people with Bruxism and Sleep Quality, run by Hacettepe 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 2 inclusion and 15 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 3 Jul 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. Some participants in this study may receive a placebo. 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 Activation Evaluation (time frame: At baseline, after 6 weeks of treatment, 4 weeks after the end of treatment). The study lists 3 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 NCT06573346, which also lists 5 linked publications.
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 3 Jul 2025.