Systemic Lupus ErythematosusNCT04453215
Laser Therapy for Patients With Systemic Lupus Erythematosus
A study testing GaAlAs semiconductor diode laser device in people with Systemic Lupus Erythematosus and Muscle Pain, run by Dr. Merve Benli at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus, Muscle Pain, Chewing Function
- What is being tested?
- GaAlAs semiconductor diode laser device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Jan 2019to 15 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having myogenic temporomandibular joint disorder,
- Following a stable medical regime,
- Showing minimum pain intensity of 50 mm on the visual analog scale.
Who cannot join
- Having concurrent systemic diseases,
- Using antimalarial drugs,
- Wearing removable prosthesis,
- History of facial trauma.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul university,Faculty of Dentistry
Fatih, 34452
About this study
Official title: 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.
- Conditions
- Systemic Lupus Erythematosus, Muscle Pain, Chewing Function
- Being tested
- GaAlAs semiconductor diode laser device
- Medical subject headings
- Lupus Erythematosus, Systemic, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GaAlAs semiconductor diode laser deviceDevice
low-level laser therapy
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | SLE patients treated with infrared laser irradiation Receives: Device: GaAlAs semiconductor diode laser device |
| placebo group | Placebo comparator | SLE patients treated with red laser irradiation Receives: Device: GaAlAs semiconductor diode laser device |
| control group | No intervention | no therapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain value
Pain intensity was evaluated by using Visual Analog Scale(VAS).
Measured: 2 months
chewing function
The chewing function was evaluated by measuring the geometric mean diameter of crushed test food.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start12 Jan 2019
- Primary completion23 Dec 2019
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Merve Benli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Merve Benli, Istanbul University
- Investigators
- merve benli, PhD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04453215
- Sponsor's protocol ID
- 1298
- Status last verified
- Nov 2021
- First submitted
- 28 Jun 2020
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: When requested by a researcher, the data can be shared without the identity of the patient.
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dental Laser Therapy for Patients With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT04453215
- Acronym / sponsor ID
- 1298
- Conditions
- Systemic Lupus Erythematosus, Muscle Pain, Chewing Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Dr. Merve BenliUniversity, hospital or other
- Study start
- 12 Jan 2019 (actual)
- Primary completion
- 23 Dec 2019 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 1 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Device: GaAlAs semiconductor diode laser deviceSLE patients treated with infrared laser irradiation |
| placebo group | Placebo comparator | Device: GaAlAs semiconductor diode laser deviceSLE patients treated with red laser irradiation |
| control group | No intervention | –no therapy group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Having myogenic temporomandibular joint disorder,
- Following a stable medical regime,
- Showing minimum pain intensity of 50 mm on the visual analog scale.
Key exclusion criteria (4 listed)
- Having concurrent systemic diseases,
- Using antimalarial drugs,
- Wearing removable prosthesis,
- History of facial trauma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GaAlAs semiconductor diode laser devicelow-level laser therapy | Device | placebo group, test group |
Primary outcome
pain value
Time frame: 2 months
Pain intensity was evaluated by using Visual Analog Scale(VAS).
chewing function
Time frame: 2 months
The chewing function was evaluated by measuring the geometric mean diameter of crushed test food.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- Individual participant dataSharing planned: Yes. When requested by a researcher, the data can be shared without the identity of the patient.
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Dapagliflozin in Active Lupus Nephritis
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A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
merve benli, PhD principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GaAlAs semiconductor diode laser device in people with Systemic Lupus Erythematosus and Muscle Pain, run by Dr. Merve Benli at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain value (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2021.