BruxismNCT07708259
Effects of Cervical and Sacroiliac Mobilization Combined With Pilates on Bruxism
A study testing Pilates-Based Exercise Program and Cervical and Sacroiliac Mobilization in people with Bruxism, run by Elif Tuğçe Çil at 1 site in Turkey (Türkiye).
Trial summary
This study investigated the effects of adding cervical and sacroiliac mobilization to a Pilates-based exercise program on pain, perceived stress, pain catastrophizing, kinesiophobia, jaw functional limitation, cervical range of motion, cervical joint position error, and sacroiliac joint screening findings in… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bruxism
- What is being tested?
- Pilates-Based Exercise Program and Cervical and Sacroiliac Mobilization
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 May 2026to 29 Jun 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between 18 and 65 years of age
- Being diagnosed with bruxism (awake bruxism and/or sleep bruxism) based on clinical presentation and self-reported symptoms
- Reporting symptoms such as jaw clenching, teeth grinding, masticatory muscle fatigue, or orofacial discomfort
- Voluntarily agreeing to participate in the study and providing written informed consent
- Having sufficient cognitive ability to understand and follow instructions
- Being physically capable of participating in a structured exercise program
- Not receiving any ongoing physiotherapy or rehabilitation program targeting the craniofacial, cervical, or lumbopelvic regions during the study period
Who cannot join
- History of surgical intervention involving the temporomandibular joint, cervical spine, or craniofacial region Presence of neurological, rheumatological, or systemic diseases that could affect movement, pain perception, or neuromuscular control Diagnosis of severe temporomandibular joint disorders that significantly limit jaw function or require specialized medical treatment Presence of acute musculoskeletal injury affecting the cervical spine, lumbar region, or lower extremities Current use of medications affecting neuromuscular function, such as muscle relaxants, sedatives, or psychotropic drugs Diagnosed psychiatric conditions that could interfere with participation or compliance with the study protocol Participation in any physiotherapy, rehabilitation, or structured exercise program targeting the craniofacial, cervical, or lumbopelvic regions during the study period Pregnancy, due to potential alterations in musculoskeletal and hormonal status Inability to attend regular sessions or complete the intervention protocol
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Noi Physio Pilates Studio
Istanbul, Ataşehir, 34755
About this study
Official title: The Effects of Cervical and Sacroiliac Mobilization Followed by Pilates-Based Training on Bruxism Severity, Perceived Stress, Pain Catastrophizing, Functional Capacity, and Proprioception in Individuals With Bruxism
This study investigated the effects of adding cervical and sacroiliac mobilization to a Pilates-based exercise program on pain, perceived stress, pain catastrophizing, kinesiophobia, jaw functional limitation, cervical range of motion, cervical joint position error, and sacroiliac joint screening findings in individuals with bruxism. Thirty-eight participants were randomly allocated to a Pilates-only group (n=19) or a Manual Therapy + Pilates group (n=19). Both groups completed an 8-week, twice-weekly Pilates protocol (16 sessions); the Manual Therapy + Pilates group additionally received cervical and sacroiliac mobilization.
Read the detailed description
Bruxism is a repetitive jaw-muscle activity associated with musculoskeletal and psychosocial dysfunction, including cervical spine impairment and altered proprioception. This randomized study examined whether adding cervical and sacroiliac mobilization to a standardized Pilates-based exercise program produces greater improvements than Pilates alone. Outcomes included pain intensity (VAS), perceived stress (PSS-10), pain catastrophizing (PCS), kinesiophobia (TSK-17), jaw functional limitation (JFLS-8), cervical range of motion (goniometry), cervical joint position error, and sacroiliac joint screening (Standing Forward Flexion Test, Gillet Test), assessed before and after the 8-week intervention.
- Conditions
- Bruxism
- Being tested
- Pilates-Based Exercise Program, Cervical and Sacroiliac Mobilization
- Keywords
- manual therapy, Bruxism, Cervical Mobilization, Sacroiliac Joint, Pilates, Proprioception
- Medical subject headings
- Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates-Based Exercise ProgramBehavioural
A structured Pilates-based exercise program targeting core stability, posture, and cervical control, performed twice weekly for 8 weeks (16 sessions total, 30-40 minutes per session).
Cervical and Sacroiliac MobilizationProcedure or surgery
Manual mobilization techniques applied to the cervical spine and sacroiliac joint, performed in addition to the Pilates-based exercise program.
| Study group | Role | What they receive |
|---|---|---|
| Pilates-only | Active comparator | Participants completed an 8-week, twice-weekly Pilates-based exercise program (16 sessions, 30-40 minutes each). Receives: Behavioral: Pilates-Based Exercise Program |
| Manual Therapy + Pilates | Experimental | Participants received cervical and sacroiliac mobilization in addition to the same 8-week, twice-weekly Pilates-based exercise program (16 sessions, 30-40 minutes each). Receives: Behavioral: Pilates-Based Exercise Program; Procedure: Cervical and Sacroiliac Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity (VAS)
Pain intensity assessed using the Visual Analog Scale (0-10 cm), with higher scores indicating greater pain.
Measured: Baseline and after 8-week intervention
Perceived Stress (PSS-10)
Perceived stress assessed using the Perceived Stress Scale-10 (PSS-10), with higher scores indicating greater perceived stress.
Measured: Baseline and after 8-week intervention
Pain Catastrophizing (PCS)
Pain catastrophizing assessed using the Pain Catastrophizing Scale (PCS), with higher scores indicating greater catastrophizing.
Measured: Baseline and after 8-week intervention
Cervical Joint Position Error
Cervical proprioception assessed via joint position error (flexion, extension, right/left rotation), with smaller error indicating better proprioceptive accuracy.
Measured: Baseline and after 8-week intervention
Secondary outcomes (3)
Cervical Range of Motion
Cervical range of motion (flexion, extension, right/left lateral flexion, right/left rotation) assessed with goniometry.
Measured: Baseline and after 8-week intervention
Kinesiophobia (TSK-17)
Fear of movement/kinesiophobia assessed using the Tampa Scale for Kinesiophobia-17 (TSK-17), with higher scores indicating greater kinesiophobia.
Measured: Baseline and after 8-week intervention
Sacroiliac Joint Screening
Sacroiliac joint status assessed using the Standing Forward Flexion Test and the Gillet Test, categorized as negative or positive (with side/structure indicated when positive).
Measured: Baseline and after 8-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start4 May 2026
- Primary completion29 Jun 2026
- Study completion29 Jun 2026
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.
- 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
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elif Tuğçe Çil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elif Tuğçe Çil, Yeditepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708259
- Sponsor's protocol ID
- Yeditepe U-122
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers, as the informed consent obtained from participants did not include provisions for sharing de-identified data beyond the scope of this study.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Cervical and Sacroiliac Mobilization Followed by Pilates-Based Training on Bruxism Severity, Perceived Stress, Pain Catastrophizing, Functional Capacity, and Proprioception in Individuals With Bruxism
- ClinicalTrials.gov ID
- NCT07708259
- Acronym / sponsor ID
- Yeditepe U-122
- Conditions
- Bruxism
- Keywords
- manual therapy, Bruxism, Cervical Mobilization, Sacroiliac Joint, Pilates, Proprioception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Elif Tuğçe ÇilUniversity, hospital or other
- Study start
- 4 May 2026 (actual)
- Primary completion
- 29 Jun 2026 (actual)
- Study completion
- 29 Jun 2026 (actual)
- First posted
- 16 Jul 2026 (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.
This study investigated the effects of adding cervical and sacroiliac mobilization to a Pilates-based exercise program on pain, perceived stress, pain catastrophizing, kinesiophobia, jaw functional limitation, cervical range of motion, cervical joint position error, and sacroiliac joint screening findings in individuals with bruxism. Thirty-eight participants were randomly allocated to a Pilates-only group (n=19) or a Manual Therapy + Pilates group (n=19). Both groups completed an 8-week, twice-weekly Pilates protocol (16 sessions); the Manual Therapy + Pilates group additionally received cervical and sacroiliac mobilization.
Detailed description
Bruxism is a repetitive jaw-muscle activity associated with musculoskeletal and psychosocial dysfunction, including cervical spine impairment and altered proprioception. This randomized study examined whether adding cervical and sacroiliac mobilization to a standardized Pilates-based exercise program produces greater improvements than Pilates alone. Outcomes included pain intensity (VAS), perceived stress (PSS-10), pain catastrophizing (PCS), kinesiophobia (TSK-17), jaw functional limitation (JFLS-8), cervical range of motion (goniometry), cervical joint position error, and sacroiliac joint screening (Standing Forward Flexion Test, Gillet Test), assessed before and after the 8-week intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates-only | Active comparator | Behavioral: Pilates-Based Exercise ProgramParticipants completed an 8-week, twice-weekly Pilates-based exercise program (16 sessions, 30-40 minutes each). |
| Manual Therapy + Pilates | Experimental | Behavioral: Pilates-Based Exercise Program, Procedure: Cervical and Sacroiliac MobilizationParticipants received cervical and sacroiliac mobilization in addition to the same 8-week, twice-weekly Pilates-based exercise program (16 sessions, 30-40 minutes each). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Being between 18 and 65 years of age
- Being diagnosed with bruxism (awake bruxism and/or sleep bruxism) based on clinical presentation and self-reported symptoms
- Reporting symptoms such as jaw clenching, teeth grinding, masticatory muscle fatigue, or orofacial discomfort
- Voluntarily agreeing to participate in the study and providing written informed consent
- Having sufficient cognitive ability to understand and follow instructions
Key exclusion criteria (1 listed)
- History of surgical intervention involving the temporomandibular joint, cervical spine, or craniofacial region Presence of neurological, rheumatological, or systemic diseases that could affect movement, pain perception, or neuromuscular control Diagnosis of severe temporomandibular joint disorders that significantly limit jaw function or require specialized medical treatment Presence of acute musculoskeletal injury affecting the cervical spine, lumbar region, or lower extremities Current use of medications affecting neuromuscular function, such as muscle relaxants, sedatives, or psychotropic drugs Diagnosed psychiatric conditions that could interfere with participation or compliance with the study protocol Participation in any physiotherapy, rehabilitation, or structured exercise program targeting the craniofacial, cervical, or lumbopelvic regions during the study period Pregnancy, due to potential alterations in musculoskeletal and hormonal status Inability to attend regular sessions or complete the intervention protocol
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 |
|---|---|---|
| Pilates-Based Exercise ProgramA structured Pilates-based exercise program targeting core stability, posture, and cervical control, performed twice weekly for 8 weeks (16 sessions total, 30-40 minutes per session). | Behavioural | Manual Therapy + Pilates, Pilates-only |
| Cervical and Sacroiliac MobilizationManual mobilization techniques applied to the cervical spine and sacroiliac joint, performed in addition to the Pilates-based exercise program. | Procedure or surgery | Manual Therapy + Pilates |
Primary outcome
Pain Intensity (VAS)
Time frame: Baseline and after 8-week intervention
Pain intensity assessed using the Visual Analog Scale (0-10 cm), with higher scores indicating greater pain.
Perceived Stress (PSS-10)
Time frame: Baseline and after 8-week intervention
Perceived stress assessed using the Perceived Stress Scale-10 (PSS-10), with higher scores indicating greater perceived stress.
Pain Catastrophizing (PCS)
Time frame: Baseline and after 8-week intervention
Pain catastrophizing assessed using the Pain Catastrophizing Scale (PCS), with higher scores indicating greater catastrophizing.
Cervical Joint Position Error
Time frame: Baseline and after 8-week intervention
Cervical proprioception assessed via joint position error (flexion, extension, right/left rotation), with smaller error indicating better proprioceptive accuracy.
3 secondary outcomes
Cervical Range of Motion
Time frame: Baseline and after 8-week intervention
Kinesiophobia (TSK-17)
Time frame: Baseline and after 8-week intervention
Sacroiliac Joint Screening
Time frame: Baseline and after 8-week intervention
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 16 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers, as the informed consent obtained from participants did not include provisions for sharing de-identified data beyond the scope of this 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 Pilates-Based Exercise Program and Cervical and Sacroiliac Mobilization in people with Bruxism, run by Elif Tuğçe Çil 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 7 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 16 Jul 2026. 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 Intensity (VAS) (time frame: Baseline and after 8-week intervention). 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?
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 16 Jul 2026.