StrokeNCT07007429
Effects of Occlusal Imbalance and Clenching on Balance in Stroke Patients
A study testing Ipsilesional Side Stimulated Occlusal Imbalance, Contralesional Side Stimulated Occlusal Imbalance and Bilateral Cotton Roll with Jaw Clenching in people with Stroke, run by Bitlis Eren University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to investigate the effects of stimulated occlusal imbalance and jaw clenching on balance and fall risk in patients with stroke. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Ipsilesional Side Stimulated Occlusal Imbalance, Contralesional Side Stimulated Occlusal Imbalance and Bilateral Cotton Roll with Jaw Clenching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2025to 22 Jul 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having chronic stroke,
- A Mini-Mental State Examination score of 24 or higher,
- Being between 18 and 75 years of age,
- Having a Brunnstrom stage of 4 or above,
- Ability to stand independently for 20 seconds or more,
- Ability to walk independently for 10 meters, using assistive devices or orthoses if necessary,
- Having opposing mandibular and maxillary second premolars or first molars
Who cannot join
- The presence of severe osteoarthritis in the lower extremity,
- The presence of cancer or diabetic neuropathy,
- The presence of vestibular disorder,
- The presence of lower extremity ulceration or amputation,
- Hemodynamic instability,
- The presence of other neurological disorders (such as multiple sclerosis, Parkinson's disease),
Show all 10Show fewer
- Having experienced an acute lower extremity injury in the last six weeks,
- History of lower extremity surgery,
- Alcohol consumption in the last 24 hours
- Posterior circulation stroke involving the basilar artery or cerebellum
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi
Bolu, Merkez, 14280
About this study
Official title: Effects of Stimulated Occlusal Imbalance and Jaw Clenching on Balance and Fall Risk in Stroke Patients
The aim of the study is to investigate the effects of stimulated occlusal imbalance and jaw clenching on balance and fall risk in patients with stroke.
Read the detailed description
This randomized controlled study will be conducted on a minimum of 42 stroke patients who meet the inclusion and exclusion criteria. Patients included in the study will be randomly assigned to one of three groups: the ipsilateral side stimulated occlusal imbalance group, the contralateral side stimulated occlusal imbalance group, or the bilateral jaw clenching group.
- Conditions
- Stroke
- Being tested
- Ipsilesional Side Stimulated Occlusal Imbalance, Contralesional Side Stimulated Occlusal Imbalance, Bilateral Cotton Roll with Jaw Clenching
- Keywords
- Balance
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ipsilesional Side Stimulated Occlusal ImbalanceOther
In this group, a 1 cm thick cotton roll will be placed on the ipsilesional occlusal surfaces of the patients, and they will be instructed to hold it in place without clenching.
Contralesional Side Stimulated Occlusal ImbalanceOther
In this group, a 1 cm thick cotton roll will be placed on the contralesional occlusal surfaces of the patients, and they will be instructed to hold it in place without clenching.
Bilateral Cotton Roll with Jaw ClenchingOther
In this group, a 1 cm thick cotton roll will be placed on both occlusal surfaces, and the patients will then be instructed to clench their teeth.
| Study group | Role | What they receive |
|---|---|---|
| Ipsilesional Side Stimulated Occlusal Imbalance Group | Experimental | In this group, occlusal imbalance will be induced by placing a cotton roll on the ipsilesional occlusal surfaces of the patients. Receives: Other: Ipsilesional Side Stimulated Occlusal Imbalance |
| Contralesional Side Stimulated Occlusal Imbalance Group | Experimental | In this group, occlusal imbalance will be induced by placing a cotton roll on the contralesional occlusal surfaces of the patients. Receives: Other: Contralesional Side Stimulated Occlusal Imbalance |
| Bilateral Cotton Roll with Jaw Clenching Group | Experimental | Patients in the bilateral cotton roll with jaw clenching group will clench their teeth while cotton rolls are placed on both sides of the occlusal surfaces. Receives: Other: Bilateral Cotton Roll with Jaw Clenching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Postural Stability Index Measurement
This index will be assessed by measuring deviations of the center of gravity in the anteroposterior and mediolateral directions. Lower scores indicate smaller deviations and better postural stability. The test will be performed on a stable platform with two trials of 30 seconds each. The average of the two trials will be automatically calculated by the TechnoBody balance system.
Measured: Change from baseline overall postural stability index immediately after the intervention
Fall Risk Assessment
Fall risk will be assessed by measuring the patient's ability to maintain balance on an unstable platform. Based on their ability to maintain balance, a fall risk score will be generated, with higher scores indicating a greater risk of falling. The test will be performed with two 30-second trials. The average of the two trials will be calculated automatically by the TechnoBody balance system.
Measured: Change from baseline fall risk immediately after the intervention
Secondary outcomes (3)
Anteroposterior Stability Index Measurement
The anteroposterior stability index will be assessed by measuring deviations of the center of gravity in the anteroposterior direction. Lower scores indicate smaller deviations and better anteroposterior postural stability. The test will be performed on a stable platform with two trials of 30 seconds each. The average of the two trials will be automatically calculated by the TechnoBody balance system.
Measured: Change from baseline anteroposterior stability index immediately after the intervention
Mediolateral Stability Index Measurement
The mediolateral stability index will be assessed by measuring deviations of the center of gravity in the mediolateral direction. Lower scores indicate smaller deviations and better mediolateral postural stability. The test will be performed on a stable platform with two trials of 30 seconds each. The average of the two trials will be automatically calculated by the TechnoBody balance system.
Measured: Change from baseline mediolateral stability index immediately after the intervention
Weight Bearing Distribution Assessment
Weight-bearing distribution will be assessed by measuring the percentage of body weight borne by each limb during quiet standing. Lower asymmetry values indicate more balanced weight distribution and better postural stability. The test will be performed on a stable platform with two trials of 30 seconds each. The average of the two trials will be automatically calculated by the TechnoBody balance system.
Measured: Change from baseline weight bearing distribution immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start15 May 2025
- Primary completion22 Jul 2025
- Study completion22 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bitlis Eren University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omer Dursun, Bitlis Eren University
- Investigators
- ömer dursun, Asst. Prof., Principal investigator, Bitlis Eren Universityburak mavuş, M.Sc., Principal investigator, Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07007429
- Sponsor's protocol ID
- BEUFTR-9
- Status last verified
- Feb 2026
- First submitted
- 19 May 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Arene N, Hidler J. Understanding motor impairment in the paretic lower limb after a stroke: a review of the literature. Top Stroke Rehabil. 2009 Sep-Oct;16(5):346-56. doi: 10.1310/tsr1605-346.
PubMed 19903653Lamb SE, Ferrucci L, Volapto S, Fried LP, Guralnik JM; Women's Health and Aging Study. Risk factors for falling in home-dwelling older women with stroke: the Women's Health and Aging Study. Stroke. 2003 Feb;34(2):494-501.
PubMed 12574566Tyson SF, Hanley M, Chillala J, Selley A, Tallis RC. Balance disability after stroke. Phys Ther. 2006 Jan;86(1):30-8. doi: 10.1093/ptj/86.1.30.
PubMed 16386060Yates JS, Lai SM, Duncan PW, Studenski S. Falls in community-dwelling stroke survivors: an accumulated impairments model. J Rehabil Res Dev. 2002 May-Jun;39(3):385-94.
PubMed 12173758Divani AA, Vazquez G, Barrett AM, Asadollahi M, Luft AR. Risk factors associated with injury attributable to falling among elderly population with history of stroke. Stroke. 2009 Oct;40(10):3286-92. doi: 10.1161/STROKEAHA.109.559195. Epub 2009 Jul 23.
PubMed 19628798Tecco S, Polimeni A, Saccucci M, Festa F. Postural loads during walking after an imbalance of occlusion created with unilateral cotton rolls. BMC Res Notes. 2010 May 25;3:141. doi: 10.1186/1756-0500-3-141.
PubMed 20500818Tecco S, Salini V, Calvisi V, Colucci C, Orso CA, Festa F, D'Attilio M. Effects of anterior cruciate ligament (ACL) injury on postural control and muscle activity of head, neck and trunk muscles. J Oral Rehabil. 2006 Aug;33(8):576-87. doi: 10.1111/j.1365-2842.2005.01592.x.
PubMed 16856955Fujimoto M, Hayakawa L, Hirano S, Watanabe I. Changes in gait stability induced by alteration of mandibular position. J Med Dent Sci. 2001 Dec;48(4):131-6.
PubMed 12160250Asseman F, Gahery Y. Effect of head position and visual condition on balance control in inverted stance. Neurosci Lett. 2005 Feb 28;375(2):134-7. doi: 10.1016/j.neulet.2004.10.085. Epub 2004 Nov 24.
PubMed 15670656Giannakopoulos NN, Schindler HJ, Hellmann D. Co-contraction behaviour of masticatory and neck muscles during tooth grinding. J Oral Rehabil. 2018 Jul;45(7):504-511. doi: 10.1111/joor.12646. Epub 2018 May 30.
PubMed 29761534Giannakopoulos NN, Schindler HJ, Rammelsberg P, Eberhard L, Schmitter M, Hellmann D. Co-activation of jaw and neck muscles during submaximum clenching in the supine position. Arch Oral Biol. 2013 Dec;58(12):1751-60. doi: 10.1016/j.archoralbio.2013.09.002. Epub 2013 Sep 20.
PubMed 24200301Giannakopoulos NN, Hellmann D, Schmitter M, Kruger B, Hauser T, Schindler HJ. Neuromuscular interaction of jaw and neck muscles during jaw clenching. J Orofac Pain. 2013 Winter;27(1):61-71. doi: 10.11607/jop.915.
PubMed 23424721
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Stimulated Occlusal Imbalance and Jaw Clenching on Balance and Fall Risk in Stroke Patients
- ClinicalTrials.gov ID
- NCT07007429
- Acronym / sponsor ID
- BEUFTR-9
- Conditions
- Stroke
- Keywords
- Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bitlis Eren UniversityUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 22 Jul 2025 (actual)
- Study completion
- 22 Jul 2025 (actual)
- First posted
- 5 Jun 2025 (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.
The aim of the study is to investigate the effects of stimulated occlusal imbalance and jaw clenching on balance and fall risk in patients with stroke.
Detailed description
This randomized controlled study will be conducted on a minimum of 42 stroke patients who meet the inclusion and exclusion criteria. Patients included in the study will be randomly assigned to one of three groups: the ipsilateral side stimulated occlusal imbalance group, the contralateral side stimulated occlusal imbalance group, or the bilateral jaw clenching group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ipsilesional Side Stimulated Occlusal Imbalance Group | Experimental | Other: Ipsilesional Side Stimulated Occlusal ImbalanceIn this group, occlusal imbalance will be induced by placing a cotton roll on the ipsilesional occlusal surfaces of the patients. |
| Contralesional Side Stimulated Occlusal Imbalance Group | Experimental | Other: Contralesional Side Stimulated Occlusal ImbalanceIn this group, occlusal imbalance will be induced by placing a cotton roll on the contralesional occlusal surfaces of the patients. |
| Bilateral Cotton Roll with Jaw Clenching Group | Experimental | Other: Bilateral Cotton Roll with Jaw ClenchingPatients in the bilateral cotton roll with jaw clenching group will clench their teeth while cotton rolls are placed on both sides of the occlusal surfaces. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Having chronic stroke,
- A Mini-Mental State Examination score of 24 or higher,
- Being between 18 and 75 years of age,
- Having a Brunnstrom stage of 4 or above,
- Ability to stand independently for 20 seconds or more,
Key exclusion criteria (10 listed)
- The presence of severe osteoarthritis in the lower extremity,
- The presence of cancer or diabetic neuropathy,
- The presence of vestibular disorder,
- The presence of lower extremity ulceration or amputation,
- Hemodynamic instability,
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 |
|---|---|---|
| Ipsilesional Side Stimulated Occlusal ImbalanceIn this group, a 1 cm thick cotton roll will be placed on the ipsilesional occlusal surfaces of the patients, and they will be instructed to hold it in place without clenching. | Other | Ipsilesional Side Stimulated Occlusal Imbalance Group |
| Contralesional Side Stimulated Occlusal ImbalanceIn this group, a 1 cm thick cotton roll will be placed on the contralesional occlusal surfaces of the patients, and they will be instructed to hold it in place without clenching. | Other | Contralesional Side Stimulated Occlusal Imbalance Group |
| Bilateral Cotton Roll with Jaw ClenchingIn this group, a 1 cm thick cotton roll will be placed on both occlusal surfaces, and the patients will then be instructed to clench their teeth. | Other | Bilateral Cotton Roll with Jaw Clenching Group |
Primary outcome
Overall Postural Stability Index Measurement
Time frame: Change from baseline overall postural stability index immediately after the intervention
This index will be assessed by measuring deviations of the center of gravity in the anteroposterior and mediolateral directions. Lower scores indicate smaller deviations and better postural stability. The test will be performed on a stable platform with two trials of 30 seconds each. The average of the two trials will be automatically calculated by the TechnoBody balance system.
Fall Risk Assessment
Time frame: Change from baseline fall risk immediately after the intervention
Fall risk will be assessed by measuring the patient's ability to maintain balance on an unstable platform. Based on their ability to maintain balance, a fall risk score will be generated, with higher scores indicating a greater risk of falling. The test will be performed with two 30-second trials. The average of the two trials will be calculated automatically by the TechnoBody balance system.
3 secondary outcomes
Anteroposterior Stability Index Measurement
Time frame: Change from baseline anteroposterior stability index immediately after the intervention
Mediolateral Stability Index Measurement
Time frame: Change from baseline mediolateral stability index immediately after the intervention
Weight Bearing Distribution Assessment
Time frame: Change from baseline weight bearing distribution immediately after the 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 11 Feb 2026.
- Background: PubMed 19903653Arene N, Hidler J. Understanding motor impairment in the paretic lower limb after a stroke: a review of the literature. Top Stroke Rehabil. 2009 Sep-Oct;16(5):346-56. doi: 10.1310/tsr1605-346.
- Background: PubMed 12574566Lamb SE, Ferrucci L, Volapto S, Fried LP, Guralnik JM; Women's Health and Aging Study. Risk factors for falling in home-dwelling older women with stroke: the Women's Health and Aging Study. Stroke. 2003 Feb;34(2):494-501.
- Background: PubMed 16386060Tyson SF, Hanley M, Chillala J, Selley A, Tallis RC. Balance disability after stroke. Phys Ther. 2006 Jan;86(1):30-8. doi: 10.1093/ptj/86.1.30.
- Background: PubMed 12173758Yates JS, Lai SM, Duncan PW, Studenski S. Falls in community-dwelling stroke survivors: an accumulated impairments model. J Rehabil Res Dev. 2002 May-Jun;39(3):385-94.
- Background: PubMed 19628798Divani AA, Vazquez G, Barrett AM, Asadollahi M, Luft AR. Risk factors associated with injury attributable to falling among elderly population with history of stroke. Stroke. 2009 Oct;40(10):3286-92. doi: 10.1161/STROKEAHA.109.559195. Epub 2009 Jul 23.
- Background: PubMed 20500818Tecco S, Polimeni A, Saccucci M, Festa F. Postural loads during walking after an imbalance of occlusion created with unilateral cotton rolls. BMC Res Notes. 2010 May 25;3:141. doi: 10.1186/1756-0500-3-141.
- Background: PubMed 16856955Tecco S, Salini V, Calvisi V, Colucci C, Orso CA, Festa F, D'Attilio M. Effects of anterior cruciate ligament (ACL) injury on postural control and muscle activity of head, neck and trunk muscles. J Oral Rehabil. 2006 Aug;33(8):576-87. doi: 10.1111/j.1365-2842.2005.01592.x.
- Background: PubMed 12160250Fujimoto M, Hayakawa L, Hirano S, Watanabe I. Changes in gait stability induced by alteration of mandibular position. J Med Dent Sci. 2001 Dec;48(4):131-6.
- Background: PubMed 15670656Asseman F, Gahery Y. Effect of head position and visual condition on balance control in inverted stance. Neurosci Lett. 2005 Feb 28;375(2):134-7. doi: 10.1016/j.neulet.2004.10.085. Epub 2004 Nov 24.
- Background: PubMed 29761534Giannakopoulos NN, Schindler HJ, Hellmann D. Co-contraction behaviour of masticatory and neck muscles during tooth grinding. J Oral Rehabil. 2018 Jul;45(7):504-511. doi: 10.1111/joor.12646. Epub 2018 May 30.
- Background: PubMed 24200301Giannakopoulos NN, Schindler HJ, Rammelsberg P, Eberhard L, Schmitter M, Hellmann D. Co-activation of jaw and neck muscles during submaximum clenching in the supine position. Arch Oral Biol. 2013 Dec;58(12):1751-60. doi: 10.1016/j.archoralbio.2013.09.002. Epub 2013 Sep 20.
- Background: PubMed 23424721Giannakopoulos NN, Hellmann D, Schmitter M, Kruger B, Hauser T, Schindler HJ. Neuromuscular interaction of jaw and neck muscles during jaw clenching. J Orofac Pain. 2013 Winter;27(1):61-71. doi: 10.11607/jop.915.
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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.
ömer dursun, Asst. Prof. principal investigator
Bitlis Eren University
burak mavuş, M.Sc. principal investigator
Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ipsilesional Side Stimulated Occlusal Imbalance, Contralesional Side Stimulated Occlusal Imbalance and Bilateral Cotton Roll with Jaw Clenching in people with Stroke, run by Bitlis Eren 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 7 inclusion and 10 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 11 Feb 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?
Overall Postural Stability Index Measurement (time frame: Change from baseline overall postural stability index immediately after the intervention). 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?
On the ClinicalTrials.gov record for NCT07007429, which also lists 12 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 11 Feb 2026.