CClinicalTrials.gg
CompletedNCT07007429Updated Feb 11, 2026

Effects of Occlusal Imbalance and Clenching on Balance in Stroke Patients

An interventional study of Ipsilesional Side Stimulated Occlusal Imbalance and Contralesional Side Stimulated Occlusal Imbalance in Stroke, sponsored by Bitlis Eren University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-11.

Sponsored by Bitlis Eren University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Stroke

Browse trials for

Keywords

  • Balance
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 60 is above the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Bitlis Eren University is the lead sponsor of 48 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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),
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Ipsilesional Side Stimulated Occlusal Imbalance Group

    In this group, occlusal imbalance will be induced by placing a cotton roll on the ipsilesional occlusal surfaces of the patients.

    Other: Ipsilesional Side Stimulated Occlusal Imbalance

  • Experimental
    Contralesional Side Stimulated Occlusal Imbalance Group

    In this group, occlusal imbalance will be induced by placing a cotton roll on the contralesional occlusal surfaces of the patients.

    Other: Contralesional Side Stimulated Occlusal Imbalance

  • Experimental
    Bilateral Cotton Roll with Jaw Clenching Group

    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.

    Other: Bilateral Cotton Roll with Jaw Clenching

Interventions

  • OtherIpsilesional Side Stimulated Occlusal Imbalance

    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.

  • OtherContralesional Side Stimulated Occlusal Imbalance

    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.

  • OtherBilateral Cotton Roll with Jaw Clenching

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Change from baseline overall postural stability index immediately after the intervention

  2. 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.

    Time frame: Change from baseline fall risk immediately after the intervention

Secondary outcomes

  1. 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.

    Time frame: Change from baseline anteroposterior stability index immediately after the intervention

  2. 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.

    Time frame: Change from baseline mediolateral stability index immediately after the intervention

  3. 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.

    Time frame: Change from baseline weight bearing distribution immediately after the intervention

07

Study locations

1 site
  • Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi
    Bolu, Merkez 14280, Turkey (Türkiye)
08

References and documents

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 19903653 ↗
  • Lamb 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 12574566 ↗
  • Tyson 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 16386060 ↗
  • Yates 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 12173758 ↗
  • Divani 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 19628798 ↗
  • Tecco 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 20500818 ↗
  • Tecco 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 16856955 ↗
  • Fujimoto 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 12160250 ↗
  • Asseman 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 15670656 ↗
  • Giannakopoulos 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 29761534 ↗
  • Giannakopoulos 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 24200301 ↗
  • Giannakopoulos 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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07007429
Lead sponsor
Bitlis Eren University
Responsible party
Omer Dursun (Asst. Prof., Bitlis Eren University) — Principal investigator
First posted
Jun 5, 2025
Start date
May 15, 2025
Primary completion
Jul 22, 2025
Completion
Jul 22, 2025
Last update
Feb 11, 2026

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion