Laser Therapy for Patients With Systemic Lupus Erythematosus

November 2, 2021 updated by: Dr. Merve Benli

The Effect of Dental 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Fatih, Turkey, 34452
        • Istanbul university,Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: test group
SLE patients treated with infrared laser irradiation
Device: GaAlAs semiconductor diode laser device
low-level laser therapy
Placebo Comparator: placebo group
SLE patients treated with red laser irradiation
Device: GaAlAs semiconductor diode laser device
low-level laser therapy
No Intervention: control group
no therapy group

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Merve Benli

Investigators

  • Principal Investigator: merve benli, PhD, Assistant Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2019

Primary Completion (Actual)

December 23, 2019

Study Completion (Actual)

March 15, 2020

Study Registration Dates

First Submitted

June 28, 2020

First Submitted That Met QC Criteria

June 28, 2020

First Posted (Actual)

July 1, 2020

Study Record Updates

Last Update Posted (Actual)

November 10, 2021

Last Update Submitted That Met QC Criteria

November 2, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1298

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

When requested by a researcher, the data can be shared without the identity of the patient.

IPD Sharing Time Frame

The data will become available when confirmed, and it will be available for one year.

IPD Sharing Access Criteria

The study protocol and patient selection will be shared.

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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