Laser Therapy for Patients With Systemic Lupus Erythematosus

• Sponsor: Dr. Merve Benli (Other)
• Overall Status: Completed
• CT.gov ID: NCT04453215
• Collaborator: (none)
• Enrollment: 91
• Location: 1
• Arms: 3
• Actual Duration (Months): 14.1
• Patients Per Site Per Month: 6.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Erythematosus; Muscle Pain; Chewing Function	Device: GaAlAs semiconductor diode laser device	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 91 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: The Effect of Dental Laser Therapy for Patients With Systemic Lupus Erythematosus
• Actual Study Start Date: Jan 12, 2019
• Actual Primary Completion Date: Dec 23, 2019
• Actual Study Completion Date: Mar 15, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. pain value [2 months]

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

2. chewing function [2 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul university,Faculty of Dentistry	Fatih		Turkey	34452

Sponsors and Collaborators

• Dr. Merve Benli

Investigators

• Principal Investigator: merve benli, PhD, Assistant Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Merve Benli, Assistant Professor, Istanbul University
• ClinicalTrials.gov Identifier: NCT04453215
• Other Study ID Numbers: 1298
• First Posted: Jul 1, 2020
• Last Update Posted: Nov 10, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Myalgia; Lupus Erythematosus, Systemic

Study Results

No Results Posted as of Nov 10, 2021