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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group
Other: Cervical spinal stabilization exercise
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
Other: Cervical spinal stabilization exercise
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Necmettin Erbakan University

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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 30, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 19, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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