Back to resultsLaser Therapy for Patients With Systemic Lupus Erythematosus
Primary Purpose
Systemic Lupus Erythematosus, Muscle Pain, Chewing Function
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
GaAlAs semiconductor diode laser device
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Lupus Erythematosus
Eligibility Criteria
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.
Sites / Locations
- Istanbul university,Faculty of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
No Intervention
Arm Label
test group
placebo group
control group
Arm Description
SLE patients treated with infrared laser irradiation
SLE patients treated with red laser irradiation
no therapy group
Outcomes
Primary Outcome Measures
pain value
Pain intensity was evaluated by using Visual Analog Scale(VAS).
chewing function
The chewing function was evaluated by measuring the geometric mean diameter of crushed test food.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04453215
Brief Title
Laser Therapy for Patients With Systemic Lupus Erythematosus
Official Title
The Effect of Dental Laser Therapy for Patients With Systemic Lupus Erythematosus
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
January 12, 2019 (Actual)
Primary Completion Date
December 23, 2019 (Actual)
Study Completion Date
March 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Merve Benli
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus, Muscle Pain, Chewing Function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
test group
Arm Type
Experimental
Arm Description
SLE patients treated with infrared laser irradiation
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
SLE patients treated with red laser irradiation
Arm Title
control group
Arm Type
No Intervention
Arm Description
no therapy group
Intervention Type
Device
Intervention Name(s)
GaAlAs semiconductor diode laser device
Intervention Description
low-level laser therapy
Primary Outcome Measure Information:
Title
pain value
Description
Pain intensity was evaluated by using Visual Analog Scale(VAS).
Time Frame
2 months
Title
chewing function
Description
The chewing function was evaluated by measuring the geometric mean diameter of crushed test food.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
merve benli, PhD
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul university,Faculty of Dentistry
City
Fatih
ZIP/Postal Code
34452
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Laser Therapy for Patients With Systemic Lupus Erythematosus
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