NCT05676827

Brief Summary

The aim of this study is to investigate the relationship of psychological aspects, selected blood parameters, pain, central sensitization, and muscle electromyography activity in patients with chronic masticatory muscle pain.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Sep 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Sep 2023Dec 2026

First Submitted

Initial submission to the registry

December 22, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 9, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

3.3 years

First QC Date

December 22, 2022

Last Update Submit

January 31, 2026

Conditions

TMDMasticatory Muscle Pain

Keywords

TMD, masticatory muscle pain, central sensitization

Outcome Measures

Primary Outcomes (3)

  • Relationship between masticatory muscle pain and polimorphism of serotonin receptor gene HTR2A - rs4941573 and dopamine receptor gene DRD3 - rs6280

    Each participant will undergo genetical blood test.

    January 3, 2023 - January 3, 2024

  • Relationship between masticatory muscle pain and serotonin and dopamine levels.

    Each participant will undergo blood test.

    January 3, 2023 - January 3, 2024

  • Relationship between masticatory muscle pain and Gamma-aminobutyric acid (GABA), Tumor Necrosis Factor α (TNF-α), CGRP, SERT, interleukin 1B, interleukin 6, interleukin 8, interleukin 10 and interleukin 17A.

    Each participant will undergo blood test.

    January 3, 2023 - January 3, 2024

Secondary Outcomes (8)

  • Relationship between masticatory muscle pain and depression assessed by Patient Health Questionnaire.

    January 3, 2023 - January 3, 2024

  • Relationship between masticatory muscle pain and PPTs.

    January 3, 2023 - January 3, 2024

  • Relationship between masticatory muscle pain and anxiety assessed by Generalized Anxiety Disorder -7.

    January 3, 2023 - January 3, 2024

  • Relationship between masticatory muscle pain and perceived stress assessed by Perceived Stress Scale.

    January 3, 2023 - January 3, 2024

  • Relationship between masticatory muscle pain and satisfaction with life assessed by Satisfaction With Life Scale.

    January 3, 2023 - January 3, 2024

  • +3 more secondary outcomes

Study Arms (2)

Study group

Participants with masticatory muscle pain lasting for over 3 months.

Diagnostic Test: Diagnostic Criteria for Temporomandibular Disorders Clinical ExaminationDiagnostic Test: Blood test

Control group

Participants without masticatory muscle pain in last 6 months.

Diagnostic Test: Diagnostic Criteria for Temporomandibular Disorders Clinical ExaminationDiagnostic Test: Blood test

Interventions

Diagnostic Criteria for Temporomandibular Disorders Clinical ExaminationDIAGNOSTIC_TEST

Clinical examination made by experienced dentists (minimum 5 years of practice) and trained and calibrated in accordance with the protocol available on the DC/TMD.

Control groupStudy group
Blood testDIAGNOSTIC_TEST

Blood samples will be tested to investigate two polymorphisms of genes encoding proteins for serotonin receptors HTR2A - rs4941573 in intron 3 and dopamine DRD3 - rs6280 (Ser9Gly) and levels of serotonin, dopamine, Gamma-aminobutyric acid (GABA), Tumor Necrosis Factor α (TNF-α), CGRP, SERT, interleukin 1B, interleukin 6, interleukin 8, interleukin 10 and interleukin 17A.

Control groupStudy group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Study population will consist of 51 patients with masticatory muscle pain for at least 3 months, diagnosed on basis of DC/TMD protocol

You may qualify if:

  • Masticatory muscle pain for at least 3 months, based on DC/TMD, at least 18 y.o

You may not qualify if:

  • severe neurological or psychiatric diseases, use of drugs that may affect the neuromuscular system, alcohol or drug addiction, cancer or pregnancy, previous head surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wroclaw Medical University

Wroclaw, Poland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

December 22, 2022

First Posted

January 9, 2023

Study Start

September 1, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 3, 2026

Record last verified: 2026-01

Locations

PL(1)