Cervical Stabilization Exercises on Bruxism and Sleep Quality

NCT06573346 | Completed

• 1 other identifier: Cervical stabilization
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bruxism; Sleep Quality; Cervical Stabilization Exercise

Outcome Measures

Primary Outcomes (3)

• Muscle Activation Evaluation

  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

  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

  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 Outcomes (2)

• Mouth Opening Evaluation

  At baseline, after 6 weeks of treatment, 4 weeks after the end of treatment

• Tongue Range of Motion Ratio Assessment

  At baseline, after 6 weeks of treatment, 4 weeks after the end of treatment

Study Arms (2)

Control group

PLACEBO COMPARATOR

Other: Cervical spinal stabilization exercise

Experimental group

EXPERIMENTAL

Other: Cervical spinal stabilization exercise

Interventions

Cervical spinal stabilization exercise OTHER

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.

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with full dentition including 2nd molars
• Patients without facial asymmetry

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead
• Necmettin Erbakan University: collaborator

Study Sites (1)

Istanbul Kent University

Istanbul, Kağıthane, 34406, Turkey (Türkiye)

Location

Related Publications (5)

• Lobbezoo F, Ahlberg J, Glaros AG, Kato T, Koyano K, Lavigne GJ, de Leeuw R, Manfredini D, Svensson P, Winocur E. Bruxism defined and graded: an international consensus. J Oral Rehabil. 2013 Jan;40(1):2-4. doi: 10.1111/joor.12011. Epub 2012 Nov 4.

  PMID: 23121262 BACKGROUND

• Lavigne GJ, Kato T, Kolta A, Sessle BJ. Neurobiological mechanisms involved in sleep bruxism. Crit Rev Oral Biol Med. 2003;14(1):30-46. doi: 10.1177/154411130301400104.

  PMID: 12764018 BACKGROUND

• Kato T, Rompre P, Montplaisir JY, Sessle BJ, Lavigne GJ. Sleep bruxism: an oromotor activity secondary to micro-arousal. J Dent Res. 2001 Oct;80(10):1940-4. doi: 10.1177/00220345010800101501.

  PMID: 11706956 BACKGROUND

• Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

  PMID: 2748771 BACKGROUND

• Hirai K, Ikawa T, Shigeta Y, Shigemoto S, Ogawa T. Evaluation of sleep bruxism with a novel designed occlusal splint. J Prosthodont Res. 2017 Jul;61(3):333-343. doi: 10.1016/j.jpor.2016.12.007. Epub 2017 Jan 18.

  PMID: 28109797 BACKGROUND

MeSH Terms

Conditions

Bruxism; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Habits; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hacettepe University

Study Record Dates

• First Submitted: August 24, 2024
• First Posted: August 27, 2024
• Study Start: August 30, 2024
• Primary Completion: February 19, 2025
• Study Completion: February 20, 2025
• Last Updated: July 3, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)