Evaluation of the Effects of Treatments Applied to Patients With Facial Myalgia on Occlusion Parameters
Primary Purpose
Occlusion, Quality of Life
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Etodolac 400 MG
Thiocolchicoside
Sponsored by
About this trial
This is an interventional treatment trial for Occlusion focused on measuring T Scan, Facial Myalgia
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Beyza Ünalan Değirmenci
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
Medical therapy
Hard Splint Therapy
Soft Splint Therapy
Arm Description
One non-steroidal anti-inflammatory drug (400mg etodolac) and one muscle relaxant drug (4 mg thiocolchicoside) were prescribed to the patients in this group.
The patients in this group were asked to use a hard splint delivered to them to use at night.
The patients in this group were asked to use a soft splint delivered to them to use at night.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05261971
First Posted
February 17, 2022
Last Updated
February 25, 2022
Sponsor
Yuzuncu Yıl University
1. Study Identification
Unique Protocol Identification Number
NCT05261971
Brief Title
Evaluation of the Effects of Treatments Applied to Patients With Facial Myalgia on Occlusion Parameters
Official Title
Evaluation of the Effects of Treatments Applied to Patients With Facial Myalgia on Quality of Life and Occlusion Parameters
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
March 24, 2020 (Actual)
Study Completion Date
April 12, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuzuncu Yıl University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Occlusion, Quality of Life
Keywords
T Scan, Facial Myalgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Medical therapy
Arm Type
No Intervention
Arm Description
One non-steroidal anti-inflammatory drug (400mg etodolac) and one muscle relaxant drug (4 mg thiocolchicoside) were prescribed to the patients in this group.
Arm Title
Hard Splint Therapy
Arm Type
Active Comparator
Arm Description
The patients in this group were asked to use a hard splint delivered to them to use at night.
Arm Title
Soft Splint Therapy
Arm Type
Active Comparator
Arm Description
The patients in this group were asked to use a soft splint delivered to them to use at night.
Intervention Type
Drug
Intervention Name(s)
Etodolac 400 MG
Other Intervention Name(s)
Etol Fort
Intervention Description
Patients were asked to drink a tablet containing 400 mg of etodolac every 24 hours with a glass of water.
Intervention Type
Drug
Intervention Name(s)
Thiocolchicoside
Other Intervention Name(s)
Muscoflex
Intervention Description
Patients were asked to drink a tablet containing 4 mg of thiocolchicoside every 24 hours with a glass of water.
Primary Outcome Measure Information:
Title
Effects of treatment method on occlusion time parameters
Description
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.
Time Frame
1 week- 6 month
Title
Effects of treatment method on distribution of right-left occlusion force percentages
Description
In each control session, researchers will record these parameters as percentages using the T-Scan III system.
Time Frame
1 week- 6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Beyza Ünalan Değirmenci
City
Van
ZIP/Postal Code
65080
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
If requested from the principal investigator, information will be shared via e-mail without time limit.
IPD Sharing Time Frame
If requested from the principal investigator, information will be shared via e-mail without time limit.
IPD Sharing Access Criteria
If requested from the principal investigator, information will be shared via e-mail without time limit.
Citations:
PubMed Identifier
11889659
Citation
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.
Results Reference
background
PubMed Identifier
1298767
Citation
Dworkin 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.
Results Reference
background
PubMed Identifier
24482784
Citation
Schiffman 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.
Results Reference
background
PubMed Identifier
26644756
Citation
Seifeldin 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.
Results Reference
background
PubMed Identifier
26174571
Citation
Nagata 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.
Results Reference
background
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Evaluation of the Effects of Treatments Applied to Patients With Facial Myalgia on Occlusion Parameters
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