Effects of Occlusal Imbalance and Clenching on Balance in Stroke Patients

NCT ID: NCT07007429

Last Updated: 2025-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-15

Study Completion Date

2025-07-22

Brief Summary

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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

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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

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
The evaluator and the researcher administering the plantar vibration intervention will be different. Patients will be blinded to their group assignment.

Study Groups

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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.

Group Type EXPERIMENTAL

Ipsilesional Side Stimulated Occlusal Imbalance

Intervention Type OTHER

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 Imbalance Group

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

Group Type EXPERIMENTAL

Contralesional Side Stimulated Occlusal Imbalance

Intervention Type OTHER

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 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.

Group Type EXPERIMENTAL

Bilateral Cotton Roll with Jaw Clenching

Intervention Type OTHER

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.

Interventions

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Ipsilesional 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.

Intervention Type OTHER

Contralesional 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.

Intervention Type OTHER

Bilateral 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.

Intervention Type OTHER

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bitlis Eren University

OTHER

Sponsor Role lead

Responsible Party

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Omer Dursun

Asst. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ömer dursun, Asst. Prof.

Role: PRINCIPAL_INVESTIGATOR

Bitlis Eren University

burak mavuş, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital

Locations

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Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi

Bolu, Merkez, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 19903653 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12574566 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16386060 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12173758 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19628798 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20500818 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16856955 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12160250 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15670656 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29761534 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24200301 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23424721 (View on PubMed)

Other Identifiers

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BEUFTR-9

Identifier Type: -

Identifier Source: org_study_id

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