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Completed

NCT Number: NCT04453215

Laser Therapy for Patients With Systemic Lupus Erythematosus

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.

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Chewing Function Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Muscle Pain Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Myalgia Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul university,Faculty of Dentistry

Fatih, 34452, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GaAlAs semiconductor diode laser device

Device

low-level laser therapy

Primary outcomes

  1. pain value

    Time frame: 2 months

    Pain intensity was evaluated by using Visual Analog Scale(VAS).

  2. chewing function

    Time frame: 2 months

    The chewing function was evaluated by measuring the geometric mean diameter of crushed test food.

Sponsors and collaborators

Lead sponsor

Dr. Merve Benli

Other

Registry information

Official study title

The Effect of Dental Laser Therapy for Patients With Systemic Lupus Erythematosus

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jul 1, 2020
Registry last updated
Nov 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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