OcclusionNCT05261971
Evaluation of the Effects of Treatments Applied to Patients With Facial Myalgia on Occlusion Parameters
A study testing Etodolac 400 MG and Thiocolchicoside in people with Occlusion and Quality of Life, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
The temporomandibular joint (TMJ) is closely related to neuromuscular components. A problem occurring in any of these components or parts of the TMJ interferes with the harmonic functioning of the TMJ and invites temporomandibular joint disorders (TMD).Management of TMD can be conservative or surgical. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Occlusion, Quality of Life
- What is being tested?
- Etodolac 400 MG and Thiocolchicoside
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2018to 12 Apr 2020
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No systemic disease that may have effects on masticatory muscles or TMJ
- Individuals who do not have any tooth loss other than molar teeth and accept the treatments to be performed.
Who cannot join
- Individuals with total or partial prosthesis with distal extension
- Individuals who have previously received medical, pharmacological or any type of treatment for TMD
- Individuals who have recently been exposed to facial or cervical trauma
- Individuals with the syndrome who have the potential to affect any component of the stomatognathic system
- Individuals with parafunctional habits such as clenching or grinding their teeth.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effects of Treatments Applied to Patients With Facial Myalgia on Quality of Life and Occlusion Parameters
The temporomandibular joint (TMJ) is closely related to neuromuscular components. A problem occurring in any of these components or parts of the TMJ interferes with the harmonic functioning of the TMJ and invites temporomandibular joint disorders (TMD).Management of TMD can be conservative or surgical. Physiotherapy, local steam application, external muscle massage, occlusal adjustment, analgesic and physiotherapeutic medication and splint treatments are the most frequently recommended conservative treatments. Today, occlusal adjustments are made with the help of a prosthetic or orthodontic appliance. With these intraorally used occlusal splints, a balanced occlusal contact is achieved without applying any force to the mandible in the resting position. Occlusal splints are available in different designs and different construction materials. The stabilization splint, which is one of the most frequently used occlusal splints, and the modified Hawley splint are appliances produced from hard materials. However, some researchers have commented that soft splints produced from resilient materials may also be useful in the distribution of excessive force formed in parafunctional habits. While there are studies stating that hard splints provide more successful results than soft splints in functional problems of the chewing system, there are also studies reporting that they have similar efficacy on muscle pain after short-term use. However, there are no studies in the literature that compare their efficacy in short-term and long-term myalgia patients and demonstrate their efficacy using an objective test such as digital occlusion analysis. There was no study on the effectiveness of different splints on the patient's quality of life. It would be appropriate to carry out our study to fill this gap in the literature.The main purpose of this study is to digitally examine and compare the effects of three different treatment methods (medical therapy, medical therapy+soft splint, medical therapy +hard splint) applied to patients diagnosed with facial myalgia after temporomandibular joint examination on the existing occlusion changes.
- Conditions
- Occlusion, Quality of Life
- Being tested
- Etodolac 400 MG, Thiocolchicoside
- Keywords
- T Scan, Facial Myalgia
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etodolac 400 MGDrug
Also called Etol Fort
Patients were asked to drink a tablet containing 400 mg of etodolac every 24 hours with a glass of water.
ThiocolchicosideDrug
Also called Muscoflex
Patients were asked to drink a tablet containing 4 mg of thiocolchicoside every 24 hours with a glass of water.
| Study group | Role | What they receive |
|---|---|---|
| Medical therapy | No intervention | One non-steroidal anti-inflammatory drug (400mg etodolac) and one muscle relaxant drug (4 mg thiocolchicoside) were prescribed to the patients in this group. |
| Hard Splint Therapy | Active comparator | The patients in this group were asked to use a hard splint delivered to them to use at night. Receives: Drug: Etodolac 400 MG; Drug: Thiocolchicoside |
| Soft Splint Therapy | Active comparator | The patients in this group were asked to use a soft splint delivered to them to use at night. Receives: Drug: Etodolac 400 MG; Drug: Thiocolchicoside |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of treatment method on occlusion time parameters
Occlusion times, left and right lateral disclusion times and protrusive disclusion times are among the occlusion parameters. In each control session, researchers will record these parameters in seconds using the T-Scan III system.
Measured: 1 week- 6 month
Effects of treatment method on distribution of right-left occlusion force percentages
In each control session, researchers will record these parameters as percentages using the T-Scan III system.
Measured: 1 week- 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 Dec 2018
- Primary completion24 Mar 2020
- Study completion12 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for OcclusionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beyza Ünalan Değirmenci, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05261971
- Sponsor's protocol ID
- 21.11.2018/01
- Status last verified
- Feb 2022
- First submitted
- 17 Feb 2022
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If requested from the principal investigator, information will be shared via e-mail without time limit.
Publications
Dworkin SF, Huggins KH, Wilson L, Mancl L, Turner J, Massoth D, LeResche L, Truelove E. A randomized clinical trial using research diagnostic criteria for temporomandibular disorders-axis II to target clinic cases for a tailored self-care TMD treatment program. J Orofac Pain. 2002 Winter;16(1):48-63.
PubMed 11889659Dworkin SF, LeResche L. Research diagnostic criteria for temporomandibular disorders: review, criteria, examinations and specifications, critique. J Craniomandib Disord. 1992 Fall;6(4):301-55. No abstract available.
PubMed 1298767Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.
PubMed 24482784Seifeldin SA, Elhayes KA. Soft versus hard occlusal splint therapy in the management of temporomandibular disorders (TMDs). Saudi Dent J. 2015 Oct;27(4):208-14. doi: 10.1016/j.sdentj.2014.12.004. Epub 2015 Jun 25.
PubMed 26644756Nagata K, Maruyama H, Mizuhashi R, Morita S, Hori S, Yokoe T, Sugawara Y. Efficacy of stabilisation splint therapy combined with non-splint multimodal therapy for treating RDC/TMD axis I patients: a randomised controlled trial. J Oral Rehabil. 2015 Dec;42(12):890-9. doi: 10.1111/joor.12332. Epub 2015 Jul 14.
PubMed 26174571
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Treatments Applied to Patients With Facial Myalgia on Quality of Life and Occlusion Parameters
- ClinicalTrials.gov ID
- NCT05261971
- Acronym / sponsor ID
- 21.11.2018/01
- Conditions
- Occlusion, Quality of Life
- Keywords
- T Scan, Facial Myalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 24 Mar 2020 (actual)
- Study completion
- 12 Apr 2020 (actual)
- First posted
- 2 Mar 2022 (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 temporomandibular joint (TMJ) is closely related to neuromuscular components. A problem occurring in any of these components or parts of the TMJ interferes with the harmonic functioning of the TMJ and invites temporomandibular joint disorders (TMD).Management of TMD can be conservative or surgical. Physiotherapy, local steam application, external muscle massage, occlusal adjustment, analgesic and physiotherapeutic medication and splint treatments are the most frequently recommended conservative treatments. Today, occlusal adjustments are made with the help of a prosthetic or orthodontic appliance. With these intraorally used occlusal splints, a balanced occlusal contact is achieved without applying any force to the mandible in the resting position. Occlusal splints are available in different designs and different construction materials. The stabilization splint, which is one of the most frequently used occlusal splints, and the modified Hawley splint are appliances produced from hard materials. However, some researchers have commented that soft splints produced from resilient materials may also be useful in the distribution of excessive force formed in parafunctional habits. While there are studies stating that hard splints provide more successful results than soft splints in functional problems of the chewing system, there are also studies reporting that they have similar efficacy on muscle pain after short-term use. However, there are no studies in the literature that compare their efficacy in short-term and long-term myalgia patients and demonstrate their efficacy using an objective test such as digital occlusion analysis. There was no study on the effectiveness of different splints on the patient's quality of life. It would be appropriate to carry out our study to fill this gap in the literature.The main purpose of this study is to digitally examine and compare the effects of three different treatment methods (medical therapy, medical therapy+soft splint, medical therapy +hard splint) applied to patients diagnosed with facial myalgia after temporomandibular joint examination on the existing occlusion changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Medical therapy | No intervention | –One non-steroidal anti-inflammatory drug (400mg etodolac) and one muscle relaxant drug (4 mg thiocolchicoside) were prescribed to the patients in this group. |
| Hard Splint Therapy | Active comparator | Drug: Etodolac 400 MG, Drug: ThiocolchicosideThe patients in this group were asked to use a hard splint delivered to them to use at night. |
| Soft Splint Therapy | Active comparator | Drug: Etodolac 400 MG, Drug: ThiocolchicosideThe patients in this group were asked to use a soft splint delivered to them to use at night. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- No systemic disease that may have effects on masticatory muscles or TMJ
- Individuals who do not have any tooth loss other than molar teeth and accept the treatments to be performed.
Key exclusion criteria (5 listed)
- Individuals with total or partial prosthesis with distal extension
- Individuals who have previously received medical, pharmacological or any type of treatment for TMD
- Individuals who have recently been exposed to facial or cervical trauma
- Individuals with the syndrome who have the potential to affect any component of the stomatognathic system
- Individuals with parafunctional habits such as clenching or grinding their teeth.
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 |
|---|---|---|
| Etodolac 400 MGAlso: Etol FortPatients were asked to drink a tablet containing 400 mg of etodolac every 24 hours with a glass of water. | Drug | Hard Splint Therapy, Soft Splint Therapy |
| ThiocolchicosideAlso: MuscoflexPatients were asked to drink a tablet containing 4 mg of thiocolchicoside every 24 hours with a glass of water. | Drug | Hard Splint Therapy, Soft Splint Therapy |
Primary outcome
Effects of treatment method on occlusion time parameters
Time frame: 1 week- 6 month
Occlusion times, left and right lateral disclusion times and protrusive disclusion times are among the occlusion parameters. In each control session, researchers will record these parameters in seconds using the T-Scan III system.
Effects of treatment method on distribution of right-left occlusion force percentages
Time frame: 1 week- 6 month
In each control session, researchers will record these parameters as percentages using the T-Scan III system.
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 2 Mar 2022.
- Background: PubMed 11889659Dworkin SF, Huggins KH, Wilson L, Mancl L, Turner J, Massoth D, LeResche L, Truelove E. A randomized clinical trial using research diagnostic criteria for temporomandibular disorders-axis II to target clinic cases for a tailored self-care TMD treatment program. J Orofac Pain. 2002 Winter;16(1):48-63.
- Background: PubMed 1298767Dworkin SF, LeResche L. Research diagnostic criteria for temporomandibular disorders: review, criteria, examinations and specifications, critique. J Craniomandib Disord. 1992 Fall;6(4):301-55. No abstract available.
- Background: PubMed 24482784Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.
- Background: PubMed 26644756Seifeldin SA, Elhayes KA. Soft versus hard occlusal splint therapy in the management of temporomandibular disorders (TMDs). Saudi Dent J. 2015 Oct;27(4):208-14. doi: 10.1016/j.sdentj.2014.12.004. Epub 2015 Jun 25.
- Background: PubMed 26174571Nagata K, Maruyama H, Mizuhashi R, Morita S, Hori S, Yokoe T, Sugawara Y. Efficacy of stabilisation splint therapy combined with non-splint multimodal therapy for treating RDC/TMD axis I patients: a randomised controlled trial. J Oral Rehabil. 2015 Dec;42(12):890-9. doi: 10.1111/joor.12332. Epub 2015 Jul 14.
- Individual participant dataSharing planned: Yes. If requested from the principal investigator, information will be shared via e-mail without time limit.
Related trials for Occlusion
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Etodolac 400 MG and Thiocolchicoside in people with Occlusion and Quality of Life, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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 2 Mar 2022. 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 Turkey (Türkiye). 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?
Effects of treatment method on occlusion time parameters (time frame: 1 week- 6 month). 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?
On the ClinicalTrials.gov record for NCT05261971, which also lists 5 linked publications.
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 2 Mar 2022.