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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04453215
Other study ID # 1298
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 12, 2019
Est. completion date March 15, 2020

Study information

Verified date November 2021
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Systemic lupus erythematosus (SLE) is a chronic, autoimmune disease that has detrimental effects on connective tissue and other organs. The musculoskeletal system is one of the most affected systems in this group of patients including the temporomandibular joint. The most common symptoms when muscle involvement in SLE are muscle atrophy decreased muscle strength and myopathy. SLE activity and long-term corticosteroid use are thought to be responsible for these symptoms, thus, SLE patients are accepted to be at higher risk for temporomandibular joint disorders (TMD). Low-level laser therapy(LLLT) is frequently used in the treatment of TMD due to its pain relief and anti-inflammatory effect. Thus, in this study, LLLT has been used to evaluate this treatment modality on the chewing function and pain values of SLE patients with myogenic TMD.


Recruitment information / eligibility

Status Completed
Enrollment 91
Est. completion date March 15, 2020
Est. primary completion date December 23, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Having myogenic temporomandibular joint disorder, - Following a stable medical regime, - Showing minimum pain intensity of 50 mm on the visual analog scale. Exclusion Criteria: - Having concurrent systemic diseases, - Using antimalarial drugs, - Wearing removable prosthesis, - History of facial trauma.

Study Design


Intervention

Device:
GaAlAs semiconductor diode laser device
low-level laser therapy

Locations

Country Name City State
Turkey Istanbul university,Faculty of Dentistry Fatih

Sponsors (1)

Lead Sponsor Collaborator
Dr. Merve Benli

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary pain value Pain intensity was evaluated by using Visual Analog Scale(VAS). 2 months
Primary chewing function The chewing function was evaluated by measuring the geometric mean diameter of crushed test food. 2 months
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