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

NCT06043024 | Completed

• 1 other identifier: 2158-61-46-23-90
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

prospective study; interventional study

Outcome Measures

Primary Outcomes (2)

• Change in cytokines level (IL-1beta, IL-13, IL-6, IL-7, IL-8, TNF alpha) in circulating blood after stabilization occlusal splint therapy

  Custom ProcartaPlex Multiplex assays will be used for multicomplex quantitative analysis of inflammatory mediators. The entire protocol will be carried out according to the instructions of the manufacturer of eBioscience, Affymetrix.

  Baseline, one month, three months

• Change in cytokines level (IL-1beta, IL-13, IL-6, IL-7, IL-8, TNF alpha) in gingival crevicular fluid (GCF) after stabilization occlusal splint therapy

  Custom ProcartaPlex Multiplex assays will be used for multicomplex quantitative analysis of inflammatory mediators. The entire protocol will be carried out according to the instructions of the manufacturer of eBioscience, Affymetrix.

  Baseline, one month, three months

Secondary Outcomes (9)

• Change in pain free opening, maximum unassisted opening and maximum assisted opening after stabilization occlusal splint therapy

  Baseline, one month, three months

• Change in pain intensity and pain-related disability after stabilization occlusal splint therapy

  Baseline, one month, three months

• Change in oral health-related quality of life in TMD patients after stabilization occlusal splint therapy

  Baseline, one month, three months

• Change in perceived stress levels in TMD patients after stabilization occlusal splint therapy

  Baseline, one month, three months

• Change in jaw function limitation in patients with TMD after stabilization occlusal splint therapy

  Baseline, one month, three months

Study Arms (1)

TMD pain group

EXPERIMENTAL

The arm includes patients with TMP pain screening scores ≥ 3 and with diagnosis of myalgia, arthralgia, headache attributed to TMP and painful disc displacement (with and without reduction) according to Axis I diagnostic criteria for temporomandibular disorders (DK/TMP). 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.

Device: Stabilization occlusal splint

Interventions

Stabilization occlusal splint DEVICE

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.

Also known as: occlusal appliance

TMD pain group

Eligibility Criteria

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

You may qualify if:

• signed informed consent
• TMP pain screening scores ≥ 3
• patients with natural teeth
• diagnoses: myalgia, arthralgia, headache attributed to TMP and painful disc displacement (with and without reduction) according to axis I diagnostic criteria for temporomandibular disorders (DK/TMP)

You may not qualify if:

• degenerative joint disease and subluxation of the temporomandibular joint (TMJ)
• head trauma
• orofacial pain not associated with temporomandibular disorders
• patients with fixed or removable prostheses
• patients who are currently undergoing orthodontic therapy and/or using occlusal splints
• patients who used anti-inflammatory drugs and muscle relaxants 48 hours before data collection, and patients who use drugs with an impact on the immune system (such as antiproliferative immunosuppressants, corticosteroids and other immunosuppressants, antirheumatic drugs, DMARDs, anti-lymphocyte monoclonal antibodies and other immunomodulating drugs , antidepressants, antiepileptics)
• periodontitis
• pregnancy

Sponsors & Collaborators

• Josip Juraj Strossmayer University of Osijek: lead

Study Sites (1)

Helath Center Osijek-Baranja county

Osijek, County of Osijek-Baranja, 31 000, Croatia

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Occlusal Splints

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Martina Smolic, Professor

  Faculty of dental medicine and health Osijek, Josip Juraj Strossmayer University Osijek

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DMD, Assistant, Faculty of Dental Medicine and Health

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 21, 2023
• Study Start: August 16, 2023
• Primary Completion: August 16, 2024
• Study Completion: August 16, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CR (1)