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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05228327
Other study ID # 66291034-604.01.01-E.66330
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2020
Est. completion date November 1, 2021

Study information

Verified date January 2022
Source Istanbul Medipol University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Myofascial pain is one of the common symptoms in patients with temporomandibular joint disorders. Occlusal splint use, trigger point injections and the combination of this two methods are primary treatment options. Patients were divided into 3 groups and this three treatment was applied. We aimed to investigate the clinical and ultrasonographic effects of the treatments. Patients in the treatment groups were reexamined at 1st and 3rd months, and their clinic and ultrasonographic records were repeated. 16 healthy volunteers were also included in the study. No treatment was applied, only clinical and ultrasonographic records were taken once.


Description:

48 patients who had myofacial pain and were diagnosed with according to Diagnostic Criteria for Temporomandibular Disorders were included in the study. There were 16 patients in each group. Group 1 was treated with occlusal splint, Group 2 was treated with occlusal splint and masseter muscle lidocaine injection, Group 3 was treated with masseter muscle lidocaine injection and Group 4 consisted of healthy volunteers. Visual analogue scale used for pain evaluation. Also, maximum mouth opening, lateral and protrusion movements of all groups were measured before any treatment. Masseter muscle volume was evaluated by ultrasonography whereas masseter muscle elasticity was evaluated by elastography before the masseter muscle lidocaine injection and occlusal splint treatment. In Group 2 and Group 3, masseter muscle injections were repeated two more times, on 7th and 14th days. Clinical and ultrasonographic measurements were repeated at 1st and 3rd months.


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Study Design


Related Conditions & MeSH terms


Intervention

Device:
Occlusal splint treatment
Occlusal splint was made for 16 patients and they used just this occlusal splint for 3 months.
Procedure:
Masticatory muscle injection
Lidocaine was injected on 16 patients' three trigger point in the masseter muscle. Injection was repeated 3 times, once a week.
Combination Product:
Combination of occlusal splint and masticatory muscle injection treatments
Lidocaine was injected on 16 patients' three trigger point in the masseter muscle. Occlusal splint was also made and they started to use the day which first injection was made. And continue to use the occlusal splint for 3 months. Injection was repeated 3 times, once a week.

Locations

Country Name City State
Turkey Istanbul Medipol University Dental School Istanbul Unkapani

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

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Outcome

Type Measure Description Time frame Safety issue
Primary The change of the elasticity of masseter muscle masseter muscle elasticity was evaluated by shear-wave sonoelastography Before the treatment (day 0), in the 1st and 3rd months of the treatment
Primary The change of the pain score Severity of the pain evaluated by the visual analog scale (VAS), rated from 0 (no pain) to 10 (the worst pain) Before the treatment (day 0), in the 1st and 3rd months of the treatment
Primary The change of the maximum mouth opening maximum mouth opening was measured by the reference of right upper and lower central incisors. Before the treatment (day 0), in the 1st and 3rd months of the treatment
Primary The change of the volume of masseter muscle masseter muscle volume was measured by ultrasonography Before the treatment (day 0), in the 1st and 3rd months of the treatment
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