Ignite Creation Date:
2024-07-17 @ 10:47 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06488937
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-28
Brief Title:
Biomarkers Associated With Temporomandibular Disorders in Patients With Rheumatoid Arthritis
Sponsor:
Josip Juraj Strossmayer University of Osijek
Organization:
Josip Juraj Strossmayer University of Osijek
Study Overview
Official Title:
Determinants of Orofacial Pain and Temporomandibular Disorders in People With Rheumatoid Arthritis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational study is to determinate temeporomandibular disorders TMDs and levels of biomarkers in 30 rheumatoid arthritis patients and 30 healthy controls
Aims are
to determine TMDs symptoms in both groups using a validated Reasearch Diagnostic Criteria for Temporomandibular Disorders RDCTMD protocol
to determine levels of interleukin-4 IL-4 interleukin-18 IL-18 and interferon-gamma IFN-γ in saliva and serum in RA patients and control group
to determine levels of biomarkers Ca Mg P ASTALTALPGGTurate in serum of RA patients and control group
investigate the correlation between cytokines level in saliva and serum
to determine the effect of TMDs on cytokine and biomarker levels Participants will be clinicaly examined by DMD in accordance with the RDCTMD guidelines to receive both Axis I and Axis II diagnoses After examination participants would be asked for saliva and blood sample
Aims are
to determine TMDs symptoms in both groups using a validated Reasearch Diagnostic Criteria for Temporomandibular Disorders RDCTMD protocol
to determine levels of interleukin-4 IL-4 interleukin-18 IL-18 and interferon-gamma IFN-γ in saliva and serum in RA patients and control group
to determine levels of biomarkers Ca Mg P ASTALTALPGGTurate in serum of RA patients and control group
investigate the correlation between cytokines level in saliva and serum
to determine the effect of TMDs on cytokine and biomarker levels Participants will be clinicaly examined by DMD in accordance with the RDCTMD guidelines to receive both Axis I and Axis II diagnoses After examination participants would be asked for saliva and blood sample
Detailed Description:
Rheumatoid arthritis RA is chronic inflammatory autoimmune disease characterized by symmetrical peripheral polyarthritis with consequent joint destruction Predominantly affecting wrist and foot joints RA can also affect temporomandibular joint TMJ causing temporomandibular disorders TMDs 4-80 of RA patients suffer from TMDs
It remains unclear why some RA patients do not have TMDs and dont suffer from orofacial pain depression and somatization The present study was therefore designed to explore the level of cytokines and biochemical parameters from saliva and serum in RA patients and control participants to examine their correlation with TMDs Study results could provide valuable insights for the understanding of the orofacial pain and depression onset in RA patients Participants would be examined by a non-blinded examiner with knowledge to which group the patient was in After intraoral examination Research Diagnostic Criteria for Temporomandibular Disorders RDCTMD will be used as an international diagnostic protocol for TMDs Assessment included clinical examination of TMJs and masticatory muscles with measurement of mandibular dynamics The participants will be requested to spit 2 mL of unstimulated saliva into a sterile tube with their head slightly bended forward Saliva samples were stored at -20 until analysis Blood samples will be collected in Vacutaners Serum calcium Ca magnesium Mg phosphate P uric acid alanine aminotransferase ALT aspartate aminotransferase AST and alkaline phosphatase ALP and gamma-glutamyltransferase GGT were measured up to 6 hours after collection Serum aliquots were stored at -20 until cytokine analysis An Invitrogen assays were used to analyze salivary and serum concentration of IL-4IL-18 and IFN-γ
It remains unclear why some RA patients do not have TMDs and dont suffer from orofacial pain depression and somatization The present study was therefore designed to explore the level of cytokines and biochemical parameters from saliva and serum in RA patients and control participants to examine their correlation with TMDs Study results could provide valuable insights for the understanding of the orofacial pain and depression onset in RA patients Participants would be examined by a non-blinded examiner with knowledge to which group the patient was in After intraoral examination Research Diagnostic Criteria for Temporomandibular Disorders RDCTMD will be used as an international diagnostic protocol for TMDs Assessment included clinical examination of TMJs and masticatory muscles with measurement of mandibular dynamics The participants will be requested to spit 2 mL of unstimulated saliva into a sterile tube with their head slightly bended forward Saliva samples were stored at -20 until analysis Blood samples will be collected in Vacutaners Serum calcium Ca magnesium Mg phosphate P uric acid alanine aminotransferase ALT aspartate aminotransferase AST and alkaline phosphatase ALP and gamma-glutamyltransferase GGT were measured up to 6 hours after collection Serum aliquots were stored at -20 until cytokine analysis An Invitrogen assays were used to analyze salivary and serum concentration of IL-4IL-18 and IFN-γ
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IP2-FDMZ-2021 | OTHER_GRANT | None | None |