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Characteristics of Cytokine Response in Patients With Temporomandibular Disorders Treated With Occlusal Splint Therapy

NCT06043024 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-09-19

No results posted yet for this study

Summary

The goal of this intervention study is to determine the effect of occlusal splint (OS) therapy on the concentration of inflammatory cytokines in serum and gingival crevicular fluid (GCF) in patients with temporomandibular disorders (TMDs).

Aims are:

* to determine cytokines level in GCF and serum before and after OS therapy
* to determine the degree of psychosocial dysfunction and oral health-related quality of life before and after OS therapy
* investigate the correlation between cytokines level in GCF and serum
* to determine the effect of OS on treatment outcomes, pain intensity, dysfunction, and psychosocial status of patients with painful TMD. Participants will be asked to complete self-assessment questionnaires, and GCF and blood samples will be collected before beginning of the OS therapy and at follow-up examinations one month and two months after.

Conditions

  • Temporomandibular Joint Disorders

Interventions

DEVICE

Stabilization occlusal splint

Patients will be treated with a stabilizing occlusal splint made of hard acrylate resin, about 1.5 mm thick in the posterior teeth area with an incisal plateau for canine guidance. OS will be made by the same dental technician in the dental laboratory.

Sponsors & Collaborators

  • Josip Juraj Strossmayer University of Osijek

    lead OTHER

Principal Investigators

  • Martina Smolic, Professor · Faculty of dental medicine and health Osijek, Josip Juraj Strossmayer University Osijek

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-16
Primary Completion
2024-08-16
Completion
2024-08-16

Countries

  • Croatia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06043024 on ClinicalTrials.gov