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Laser Therapy for Patients With Systemic Lupus Erythematosus

NCT ID: NCT04453215

Last Updated: 2021-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-12

Study Completion Date

2020-03-15

Brief Summary

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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.

Detailed Description

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Conditions

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Systemic Lupus Erythematosus Muscle Pain Chewing Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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test group

SLE patients treated with infrared laser irradiation

Group Type EXPERIMENTAL

GaAlAs semiconductor diode laser device

Intervention Type DEVICE

low-level laser therapy

placebo group

SLE patients treated with red laser irradiation

Group Type PLACEBO_COMPARATOR

GaAlAs semiconductor diode laser device

Intervention Type DEVICE

low-level laser therapy

control group

no therapy group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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GaAlAs semiconductor diode laser device

low-level laser therapy

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dr. Merve Benli

OTHER

Sponsor Role lead

Responsible Party

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Dr. Merve Benli

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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merve benli, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

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Istanbul university,Faculty of Dentistry

Fatih, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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1298

Identifier Type: -

Identifier Source: org_study_id