Low Level Laser and Occlusal SplintNCT04456946
Prospective Investigation of the Effects of Different Treatment Techniques on Myofascial Trigger Points in Patients With Temporomandibular Dysfunction (TMD)
A study testing Low Level Laser Therapy and Occlusal Splint Treatment in people with Low Level Laser and Occlusal Splint, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
In the literature, there are no studies comparing the use of occlusal splint and Low Level Laser (LLL) in the treatment of Temporomandibular Disfunction (TMD) and including Ultrasonography (USG) in these parameters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Level Laser and Occlusal Splint
- What is being tested?
- Low Level Laser Therapy and Occlusal Splint Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Apr 2022to 1 Apr 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over the age of 18 who apply with Temporomandibular Joint (TMJ) problems
- Patients with pain in the joint and chewing muscle area
Who cannot join
- Syndromic patients
- Patients under the age of 18
- Patients with a history of orthognathic surgery
- Pregnants
- Antidepressant Users
- Patients Using Removable Dentures
- Patients who have had joint treatment in the past six months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Dentistry Faculty
Istanbul, Fatih, 34200
About this study
In the literature, there are no studies comparing the use of occlusal splint and Low Level Laser (LLL) in the treatment of Temporomandibular Disfunction (TMD) and including Ultrasonography (USG) in these parameters. In this study, it is aimed to contribute to the literature in terms of determining which treatment method is more effective by evaluating the changes in the needles muscles with the use of occlusal splints and LLL with USG and other parameters in certain periods, as well as evaluating which parameters are more effective.
- Conditions
- Low Level Laser and Occlusal Splint
- Being tested
- Low Level Laser Therapy, Occlusal Splint Treatment
- Keywords
- Low Level Laser, Occlusal Splint, Temporomandibular Disfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Level Laser TherapyDevice
Low Level Laser Therapy
Occlusal Splint TreatmentDevice
Occlusal Splint Treatment
| Study group | Role | What they receive |
|---|---|---|
| Group of Low Level Laser Therapy | Experimental | Not described Receives: Device: Low Level Laser Therapy |
| Group of Occlusal Splint Treatment | Experimental | Not described Receives: Device: Occlusal Splint Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint Pain Scale
Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) form will be used in our study
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start12 Apr 2022
- Primary completion1 Apr 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Level Laser and Occlusal SplintStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Faruk ERTURK, Istanbul University
- Investigators
- Ahmet Faruk Erturk, Assistant Professor, Principal investigator, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456946
- Sponsor's protocol ID
- 2019/72
- Other IDs
- 34978, 2019-190
- Status last verified
- Apr 2023
- First submitted
- 23 Jun 2020
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Investigation of the Effects of Different Treatment Techniques on Myofascial Trigger Points in Patients With Temporomandibular Dysfunction (TMD)
- ClinicalTrials.gov ID
- NCT04456946
- Acronym / sponsor ID
- 2019/72
- Conditions
- Low Level Laser and Occlusal Splint
- Keywords
- Low Level Laser, Occlusal Splint, Temporomandibular Disfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 12 Apr 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 7 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.
In the literature, there are no studies comparing the use of occlusal splint and Low Level Laser (LLL) in the treatment of Temporomandibular Disfunction (TMD) and including Ultrasonography (USG) in these parameters. In this study, it is aimed to contribute to the literature in terms of determining which treatment method is more effective by evaluating the changes in the needles muscles with the use of occlusal splints and LLL with USG and other parameters in certain periods, as well as evaluating which parameters are more effective.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group of Low Level Laser Therapy | Experimental | Device: Low Level Laser Therapy |
| Group of Occlusal Splint Treatment | Experimental | Device: Occlusal Splint Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over the age of 18 who apply with Temporomandibular Joint (TMJ) problems
- Patients with pain in the joint and chewing muscle area
Key exclusion criteria (7 listed)
- Syndromic patients
- Patients under the age of 18
- Patients with a history of orthognathic surgery
- Pregnants
- Antidepressant Users
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 |
|---|---|---|
| Low Level Laser TherapyLow Level Laser Therapy | Device | Group of Low Level Laser Therapy |
| Occlusal Splint TreatmentOcclusal Splint Treatment | Device | Group of Occlusal Splint Treatment |
Primary outcome
Joint Pain Scale
Time frame: 2 years
Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) form will be used in our study
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 11 Apr 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Low Level Laser and Occlusal Splint
Recruiting
Clinical and Electromyographic Assessment of Occlusal Splint Therapy
Temporomandibular Joint Disorders
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.
Ahmet Faruk Erturk, Assistant Professor principal investigator
Biruni University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Level Laser Therapy and Occlusal Splint Treatment in people with Low Level Laser and Occlusal Splint, run by Istanbul University 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 2 inclusion and 7 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 11 Apr 2023. 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. 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?
Joint Pain Scale (time frame: 2 years). 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 11 Apr 2023.