- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06573346
Cervical Stabilization Exercises on Bruxism and Sleep Quality
June 30, 2025 updated by: Emine Nur Demircan, Hacettepe University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kağıthane
-
Istanbul, Kağıthane, Turkey, 34406
- Istanbul Kent University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Patients with full dentition including 2nd molars
- Patients without facial asymmetry
Exclusion Criteria:
- 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)
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
|
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.
|
|
Placebo Comparator: Control group
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
At baseline, after 6 weeks of treatment, 4 weeks after the end of treatment
|
|
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)
|
At baseline, after 6 weeks of treatment, 4 weeks after the end of treatment
|
|
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)
|
At baseline, after 6 weeks of treatment, 4 weeks after the end of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mouth Opening Evaluation
Time Frame: At baseline, after 6 weeks of treatment, 4 weeks after the end of treatment
|
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)
|
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
|
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)
|
At baseline, after 6 weeks of treatment, 4 weeks after the end of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Buysse 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.
- 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.
- Lavigne 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.
- Kato 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.
- Hirai 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 30, 2024
Primary Completion (Actual)
February 19, 2025
Study Completion (Actual)
February 20, 2025
Study Registration Dates
First Submitted
August 24, 2024
First Submitted That Met QC Criteria
August 24, 2024
First Posted (Actual)
August 27, 2024
Study Record Updates
Last Update Posted (Actual)
July 3, 2025
Last Update Submitted That Met QC Criteria
June 30, 2025
Last Verified
August 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Cervical stabilization
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bruxism
-
Melek Volkan YaziciCompletedBruxism | Bruxism, Sleep-Related | Bruxism, SleepTurkey (Türkiye)
-
University of MonastirCompletedBruxism | Bruxism, Sleep-RelatedTunisia
-
Baskent UniversityRecruiting
-
Nigde Omer Halisdemir UniversityRecruitingBruxism | Bruxism, Sleep-RelatedTurkey (Türkiye)
-
Cappadocia UniversityCompleted
-
Escoles Universitaries GimbernatUniversitat Internacional de CatalunyaNot yet recruitingBruxism, SleepSpain
-
Karabuk UniversityCompleted
-
Riyadh Colleges of Dentistry and PharmacyUnknownNocturnal BruxismSaudi Arabia
-
CES UniversityNot yet recruitingSleep Bruxism, Childhood
-
Otis Dental, LLCTerminatedBruxism, Sleep-RelatedUnited States
Clinical Trials on Cervical spinal stabilization exercise
-
Hacettepe UniversityBElibol; NKöse; GYÇakmaklı; SAksoy; RGöçmenCompletedParkinson DiseaseTurkey
-
National Cheng Kung UniversityCompleted
-
Hacettepe UniversityRecruiting
-
Hasan Kalyoncu UniversityCompletedChronic Low-back PainTurkey
-
Muş Alparlan UniversityCompletedIntervertebral Disc Displacement | Disk Herniated Lumbar | Disc HerniationTurkey
-
Hacettepe UniversityCompleted
-
Seoul National University HospitalActive, not recruitingScoliosis IdiopathicKorea, Republic of
-
Ankara Yildirim Beyazıt UniversityNot yet recruiting
-
Şenay ÖzdolapZonguldak Bulent Ecevit UniversityCompletedNeck Pain | Chronic Neck PainTurkey
-
National Cheng Kung UniversityMinistry of Science and Technology, TaiwanCompletedNeck Pain | Inhalation | Exercise Training | DiaphragmTaiwan