Temporomandibular Joint DisordersNCT06043024
Characteristics of Cytokine Response in Patients With Temporomandibular Disorders Treated With Occlusal Splint Therapy
A study testing Stabilization occlusal splint in people with Temporomandibular Joint Disorders, run by Josip Juraj Strossmayer University of Osijek at 1 site in Croatia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- Stabilization occlusal splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCroatia
- Study dates
- 16 Aug 2023to 16 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Croatia1 site
Helath Center Osijek-Baranja county
Osijek, County of Osijek-Baranja, 31 000
About this study
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.
Read the detailed description
Temporomandibular disorder (TMD) is a multifactorial disease with complex etiopathogenesis. The main symptoms are persistent pain in the masticatory muscles and preauricular region, limitations in jaw function, and sounds in the temporomandibular joints. The most commonly used therapy is the occlusal splint (OS). The therapeutic effect of OS is attributed to various factors, however the exact mechanism is still unknown. One of the potential diagnostic methods is the use of molecular biomarkers. Studies have demonstrated a correlation between inflammatory cytokines and pain in TMD patients compared to healthy controls. Molecular biomarker levels can be determined from tissue samples and body fluids. Gingival crevicular fluid (GCF) is a serum exudate that enters the gingival sulcus from the gingival plexus of blood vessels and contains proteins, various cell types, electrolytes, cytokines, etc. Considering its composition, wide availability, non-invasive method, and speed of collection, GCF could be a new source of TMD biomarkers with potential diagnostic, prognostic, and therapeutic purposes.
Participants diagnosed with myalgia, arthralgia, headache attributed to TMP and/or painful disk displacement (with and without reduction) according to DC /TMD will be included in the study. Participants will be asked to complete self-assessment questionnaires: Graded Chronic Pain Scale (v2), Jaw Functional Limitation Scale-20, Patient Health Questionnaire-9, Genaral Anxiety Disorder-7, Patient Health Questionnaire-15, Oral Behaviors Checklist, Oral health Impact Profile, and Perceived Stress Scale-10. The occlusal splints will be fabricated from hard acrylic resin by the same dental technician in the dental laboratory. The GCF sample will be collected from the sulcus using sterile tweezers and sterile paper sticks and placed in an Eppendorf tube containing 250 µl of 0.9% NaCl solution. Blood samples will be collected in Vacutainers and stored at +4°C until centrifugation. For multicomplex quantitative analysis of proinflammatory cytokines (interleukin 1 beta (IL -1β), interleukin 6 (IL - 6), interleukin 7 (IL -7), interleukin 8 (IL -8), interleukin 13 (IL -13), tumor necrosis factor alpha (TNF-α)), adapted ProcartaPlex multiplex assays will be used.
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- Stabilization occlusal splint
- Keywords
- prospective study, interventional study
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stabilization occlusal splintDevice
Also called occlusal appliance
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Stabilization occlusal splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measuring the distance using a ruler between the incisal edge of the reference mandibular and maxillary incisor. Patients will be asked to open their mouth without feeling pain, then to open as wide as possible even though it is painful and the examiner will try to stretch the mouth with fingers further if possible.
Measured: Baseline, one month, three months
Change in pain intensity and pain-related disability after stabilization occlusal splint therapy
Pain intensity and pain-related disability will be calculated using version 2 of the Graded Chronic Pain Scale (GCPSv2) self-report questionnaire from Axis II of Diagnostic Criteria for Temporomandibular Disorders (DC/TMP) with 3 items for pain intensity, 4 items for function and one item for number of days of pain. Characteristic Pain Intensity (CPI) is calculated by taking the mean value of items 2-4 (current pain, worst pain, average pain) and then multiplying by 10. Interference score is a score derived from the computed mean of items 6-8 (daily activities, social activities, work activities) and multiplied by 10. The total Disability Points are calculated by the sum of Points for Disability Days and Points for Interference Score. Classification of Chronic Pain Grade: Grade 0-no TMD pain; Grade I- low-intensity pain, without disability; Grade II- high-intensity pain, without disability; Grade III- moderately limiting; Grade IV- severely limiting.
Measured: Baseline, one month, three months
Change in oral health-related quality of life in TMD patients after stabilization occlusal splint therapy
Oral health-related quality of life will be measured using the oral health impact profile (OHIP-14) questionnaire. OHIP-14 is a 14-item questionnaire with answers rated on a 5-point Likert scale. The total score is the sum of all answered items and the scale ranges from 0 to 56. As the total score increases, the quality of life decreases.
Measured: Baseline, one month, three months
Change in perceived stress levels in TMD patients after stabilization occlusal splint therapy
Perceived stress levels will be measured with the self-assessment questionnaire Perceived Stress Scale-10 (PSS). PSS is a 10-item instrument with answers rated on a 5-point scale. A total PSS score will be calculated as a sum of all items after four positively stated items (items 4, 5, 7, and 8) are reversed. Higher scores indicate higher levels of perceived stress.
Measured: Baseline, one month, three months
Change in jaw function limitation in patients with TMD after stabilization occlusal splint therapy
Change in jaw function limitation will be determined using the self-assessment questionnaire Jaw Functional Limitation Scale-20 (JFLS-20) from Axis II of DC/TMD. JFLS-20 is a 20-item instrument. The total score can be calculated as a mean value of available items while subscale scores for each type of functional limitation are calculated: chewing: mean of items 1-6; mobility: mean value of items 7-10; verbal and non-verbal communication: mean value of particles 13-20.
Measured: Baseline, one month, three months
Change in depressed mood in patients with TMD after stabilization occlusal splint therapy
Change in depressed mood will be determined using the self-assessment questionnaire Patient Health Questionnaire-9 (PHQ-9). The total score is obtained by the sum of all points. The scale ranges from 0-27 with cut-points at 5, 10, 15, and 20 representing mild, moderate, moderately severe, and severe depression, respectively.
Measured: Baseline, one month, three months
Change in anxious feelings and behavior in patients with TMD after stabilization occlusal splint therapy
Change in anxious feelings and behavior will be determined using the self-assessment questionnaire Genaral Anxiety Disorder-7 (GAD-7). The total score is obtained by the sum of all points. The scale ranges from 0 to 21, with cut-points at 5, 10, and 15 representing mild, moderate, and severe anxiety, respectively.
Measured: Baseline, one month, three months
Change in physical symptoms in patients with TMD after stabilization occlusal splint therapy
Change in non-specific physical symptoms will be determined using a 15-item self-assessment questionnaire Patient Health Questionnaire-15 (PHQ-15) from Axis II of DC/TMD. Individual answers are scored and their sum gives the final result. The scale ranges from 0 to 30, with cut-points at 5, 10, and 15 representing low, medium, and high physical symptoms, respectively.
Measured: Baseline, one month, three months
Change in the presence of parafunctional behaviors in patients with TMD after stabilization occlusal splint therapy
Change in the presence of parafunctional behaviors will be determined using the self-assessment questionnaire Oral Behaviors Checklist (OBC) from Axis II of DC/TMD. Scoring can be calculated as the sum of questions with a non-zero response. The scale ranges from 0 to 62. A score of 0-16 represents normal behaviors; a score of 17-24 occurs twice as often in TMD patients than in healthy individuals; a score of 25-62 represents a risk factor for TMD.
Measured: Baseline, one month, three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start16 Aug 2023
- Primary completion16 Aug 2024
- Study completion16 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Josip Juraj Strossmayer University of Osijek
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renata Sikora, DMD, Josip Juraj Strossmayer University of Osijek
- Investigators
- Martina Smolic, Professor, Study director, Faculty of dental medicine and health Osijek, Josip Juraj Strossmayer University Osijek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043024
- Sponsor's protocol ID
- 2158-61-46-23-90
- Status last verified
- Sep 2024
- First submitted
- 8 Sep 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Cytokine Response in Patients With Temporomandibular Disorders Treated With Occlusal Splint Therapy
- ClinicalTrials.gov ID
- NCT06043024
- Acronym / sponsor ID
- 2158-61-46-23-90
- Conditions
- Temporomandibular Joint Disorders
- Keywords
- prospective study, interventional study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Josip Juraj Strossmayer University of OsijekUniversity, hospital or other
- Study start
- 16 Aug 2023 (actual)
- Primary completion
- 16 Aug 2024 (actual)
- Study completion
- 16 Aug 2024 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Temporomandibular disorder (TMD) is a multifactorial disease with complex etiopathogenesis. The main symptoms are persistent pain in the masticatory muscles and preauricular region, limitations in jaw function, and sounds in the temporomandibular joints. The most commonly used therapy is the occlusal splint (OS). The therapeutic effect of OS is attributed to various factors, however the exact mechanism is still unknown. One of the potential diagnostic methods is the use of molecular biomarkers. Studies have demonstrated a correlation between inflammatory cytokines and pain in TMD patients compared to healthy controls. Molecular biomarker levels can be determined from tissue samples and body fluids. Gingival crevicular fluid (GCF) is a serum exudate that enters the gingival sulcus from the gingival plexus of blood vessels and contains proteins, various cell types, electrolytes, cytokines, etc. Considering its composition, wide availability, non-invasive method, and speed of collection, GCF could be a new source of TMD biomarkers with potential diagnostic, prognostic, and therapeutic purposes.
Participants diagnosed with myalgia, arthralgia, headache attributed to TMP and/or painful disk displacement (with and without reduction) according to DC /TMD will be included in the study. Participants will be asked to complete self-assessment questionnaires: Graded Chronic Pain Scale (v2), Jaw Functional Limitation Scale-20, Patient Health Questionnaire-9, Genaral Anxiety Disorder-7, Patient Health Questionnaire-15, Oral Behaviors Checklist, Oral health Impact Profile, and Perceived Stress Scale-10. The occlusal splints will be fabricated from hard acrylic resin by the same dental technician in the dental laboratory. The GCF sample will be collected from the sulcus using sterile tweezers and sterile paper sticks and placed in an Eppendorf tube containing 250 µl of 0.9% NaCl solution. Blood samples will be collected in Vacutainers and stored at +4°C until centrifugation. For multicomplex quantitative analysis of proinflammatory cytokines (interleukin 1 beta (IL -1β), interleukin 6 (IL - 6), interleukin 7 (IL -7), interleukin 8 (IL -8), interleukin 13 (IL -13), tumor necrosis factor alpha (TNF-α)), adapted ProcartaPlex multiplex assays will be used.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TMD pain group | Experimental | Device: Stabilization occlusal splintThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stabilization occlusal splintAlso: occlusal appliancePatients 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. | Device | TMD pain group |
Primary outcome
Change in cytokines level (IL-1beta, IL-13, IL-6, IL-7, IL-8, TNF alpha) in circulating blood after stabilization occlusal splint therapy
Time frame: Baseline, one month, three months
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.
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
Time frame: Baseline, one month, three months
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.
9 secondary outcomes
Change in pain free opening, maximum unassisted opening and maximum assisted opening after stabilization occlusal splint therapy
Time frame: Baseline, one month, three months
Change in pain intensity and pain-related disability after stabilization occlusal splint therapy
Time frame: Baseline, one month, three months
Change in oral health-related quality of life in TMD patients after stabilization occlusal splint therapy
Time frame: Baseline, one month, three months
Change in perceived stress levels in TMD patients after stabilization occlusal splint therapy
Time frame: Baseline, one month, three months
Change in jaw function limitation in patients with TMD after stabilization occlusal splint therapy
Time frame: Baseline, one month, three months
Change in depressed mood in patients with TMD after stabilization occlusal splint therapy
Time frame: Baseline, one month, three months
Change in anxious feelings and behavior in patients with TMD after stabilization occlusal splint therapy
Time frame: Baseline, one month, three months
Change in physical symptoms in patients with TMD after stabilization occlusal splint therapy
Time frame: Baseline, one month, three months
Change in the presence of parafunctional behaviors in patients with TMD after stabilization occlusal splint therapy
Time frame: Baseline, one month, three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martina Smolic, Professor study director
Faculty of dental medicine and health Osijek, Josip Juraj Strossmayer University Osijek
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stabilization occlusal splint in people with Temporomandibular Joint Disorders, run by Josip Juraj Strossmayer University of Osijek at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cytokines level (IL-1beta, IL-13, IL-6, IL-7, IL-8, TNF alpha) in circulating blood after stabilization occlusal splint therapy (time frame: Baseline, one month, three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.