Evaluation of the Effect of Muscle Activity on Subjective Tinnitus in Temporomandibular Disorders

NCT05830604 | Completed

• 1 other identifier: 2021-09/07
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Treatment of Temporomandibular Joint Disorder can help reduce subjective tinnitus levels. This treatment changes the electrical activity of the patient's chewing muscles. For this reason, the relationship between muscular change and tinnitus levels can be evaluated.

Conditions

Tinnitus, Subjective; Temporomandibular Disorder

Outcome Measures

Primary Outcomes (1)

• Masseters Activity

  To evaluate the symmetry and electrical activity of masseters by surface EMG

  6th months

Study Arms (2)

TMD Wilkes Stage I-II and Subjective Tinnitus

ACTIVE COMPARATOR

Patients with subjective tinnitus and temporomandibular disorder. It was treated with an occlusal splint.

Procedure: Occlusal Splint Treatment- Non Invasive treatment

TMD Wilkes Stage I-II, Subjective Tinnitus and Bruxism

ACTIVE COMPARATOR

Patients with subjective tinnitus and temporomandibular disorder and bruxism. It was treated with an occlusal splint.

Procedure: Occlusal Splint Treatment- Non Invasive treatment

Interventions

Occlusal Splint Treatment- Non Invasive treatment PROCEDURE

Each patient in the study had temporomandibular disorder. The first-line routine treatment of this disease is an occlusal splint. This treatment was applied to each patient. Surgical intervention was not performed.

TMD Wilkes Stage I-II and Subjective Tinnitus; TMD Wilkes Stage I-II, Subjective Tinnitus and Bruxism

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years
• Patients with chronic subjective tinnitus
• Patients with Wilkes Stage 1-2

You may not qualify if:

• Patients with Wilkes Stage 3-4-5
• Patients with tinnitus due to audiological, neurological, metabolic or pathological reasons
• Patients with objective tinnutus
• Patients with normal tinnitus
• Mentally retarded patients
• Hearing loss, use of ototoxic drugs
• Those with ear diseases such as acute ostitis media, perforated tympanic membrane
• Those with Meniere's disease
• Patients with middle ear pathology
• Those with intracranial pathology
• Those with traumatic cervical spine injury
• Patients with severe depression diagnosed by a psychologist
• Patients who have received TMB treatment in the last two months

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kütahya Health Science University

Kütahya, 43100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tinnitus; Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Officials

• Elif Çoban, DDS

  https://avesis.ksbu.edu.tr/elif.coban/iletisim

  PRINCIPAL INVESTIGATOR

• Mehmet Ç. Ulucan, DDS

  https://avesis.ksbu.edu.tr/mehmetcagatay.ulucan

  PRINCIPAL INVESTIGATOR

• Selver S. Başak, DDS

  https://avesis.ksbu.edu.tr/selversuna.basak

  PRINCIPAL INVESTIGATOR

• Berceste Güler, DDS

  https://avesis.ksbu.edu.tr/berceste.guler

  PRINCIPAL INVESTIGATOR

• Merve Akdeniz Leblebiciler, MD

  https://avesis.ksbu.edu.tr/merve.akdenizleblebicier

  PRINCIPAL INVESTIGATOR

• Vural Kavuncu, MD

  https://avesis.ksbu.edu.tr/vural.kavuncu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, Assist. Prof. Department of Oral and Maxillofacial Surgery

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 26, 2023
• Study Start: December 21, 2021
• Primary Completion: June 21, 2022
• Study Completion: December 21, 2022
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)