Myalgia of Mastication MuscleNCT07588841
Evaluation of Low Energy Level Laser Biostimulation at Different Energy Densities in the Treatment of Temporomandibular Joint Irregularities: A Retrospective Study
A study testing Low Level Laser Therapy and Dietary Supplement in people with Myalgia of Mastication Muscle, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
This clinical study aimed to evaluate the effectiveness of low-level laser therapy in patients with temporomandibular disorders (TMD), specifically disc displacement with reduction and myalgia. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Myalgia of Mastication Muscle
- What is being tested?
- Low Level Laser Therapy and Dietary Supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Sep 2022to 24 Dec 2024
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of disc displacement with reduction (DDwR) and myalgia according to DC/TMD criteria Presence of temporomandibular joint pain and functional limitation Patients aged 18 years and older No previous temporomandibular joint (TMJ) treatment Absence of systemic diseases Willingness to participate and provide informed consent
Who cannot join
- History of previous TMJ treatment (e.g., conservative or surgical treatment) Congenital or inflammatory joint disease Severe systemic diseases Edentulous patients Children and adolescents in the active growth period Acute trauma history involving the TMJ region Inability or unwillingness to complete follow-up visits
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karadeniz Technical University
Trabzon, Trabzon, 61000
About this study
Official title: The Study Was Conducted by Retrospectively Analysing the Files of Patients Who Presented With Temporomandibular Joint Disorder (TMD) and Underwent LLEL Treatment. Patients Were Divided Into Myalgia, Disc Displacement With Reduction and Follow-up Groups. In Our Study, GaAl-As Diode Laser (EzLase 940, Biolase Technology, Inc. 4 Cromwell Irvine, USA) for Lowlevel Laser Treatment Was Applied for 1 Minute to Subgroup 1 (940 nm, 1. 5 W, 90 J, Continuous), Subgroup 2 (940 nm, 3 W, 180J, Continuous) and Subgroup 1 (940 nm, 1.5 W, 90J, Continuous) and Subgroup 2 (940 nm, 3 W, 180J, Continuous).
This clinical study aimed to evaluate the effectiveness of low-level laser therapy in patients with temporomandibular disorders (TMD), specifically disc displacement with reduction and myalgia. The study compared laser therapy with a soft diet approach to determine whether laser treatment provides additional benefits in reducing pain and improving jaw function
- Conditions
- Myalgia of Mastication Muscle
- Being tested
- Low Level Laser Therapy, Dietary Supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Level Laser TherapyOther
Participants received low-level laser therapy applied to the temporomandibular joint region in addition to soft diet recommendations. Treatment was performed in 9 sessions according to the predefined laser protocol. Participants followed a soft diet regimen without receiving laser therapy and served as the comparison group.
Dietary SupplementOther
Participants in this group did not receive laser therapy and were instructed to follow a soft diet during the study period. This group served as the comparison group for evaluating treatment outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Low Level Laser Therapy | Active comparator | Participants in this group received low-level laser therapy applied to the temporomandibular joint region according to the predefined treatment protocol. Laser therapy was administered for 2 minutes per joint over 9 treatment sessions. Patients were also advised to follow a soft diet during the treatment period. Receives: Other: Low Level Laser Therapy |
| soft diet group | Other | Soft Diet Group:
Participants in this group did not receive laser therapy and were instructed to follow a soft diet during the study period. This group served as the comparison group for evaluating treatment outcomes. Receives: Other: Dietary Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in temporomandibular pain intensity measured by the Visual Analog Scale (VAS) from baseline to the end of treatment and follow-up
Change in temporomandibular pain intensity was assessed using the Visual Analog Scale (VAS) from baseline to the end of treatment and follow-up. The Visual Analog Scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores represent greater pain severity.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start3 Sep 2022
- Primary completion24 Dec 2024
- Study completion24 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myalgia of Mastication MuscleStudies 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
- Model description
- Participants were assigned to one of two parallel groups: a low-level laser therapy group or a soft diet group. Outcomes were assessed at baseline, after completion of treatment sessions, and during follow-up evaluations.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emil Mahammadli, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07588841
- Sponsor's protocol ID
- 64529847/7
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be publicly shared due to privacy and confidentiality considerations related to patient data
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study Was Conducted by Retrospectively Analysing the Files of Patients Who Presented With Temporomandibular Joint Disorder (TMD) and Underwent LLEL Treatment. Patients Were Divided Into Myalgia, Disc Displacement With Reduction and Follow-up Groups. In Our Study, GaAl-As Diode Laser (EzLase 940, Biolase Technology, Inc. 4 Cromwell Irvine, USA) for Lowlevel Laser Treatment Was Applied for 1 Minute to Subgroup 1 (940 nm, 1. 5 W, 90 J, Continuous), Subgroup 2 (940 nm, 3 W, 180J, Continuous) and Subgroup 1 (940 nm, 1.5 W, 90J, Continuous) and Subgroup 2 (940 nm, 3 W, 180J, Continuous).
- ClinicalTrials.gov ID
- NCT07588841
- Acronym / sponsor ID
- 64529847/7
- Conditions
- Myalgia of Mastication Muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 3 Sep 2022 (actual)
- Primary completion
- 24 Dec 2024 (actual)
- Study completion
- 24 Dec 2024 (actual)
- First posted
- 15 May 2026 (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.
This clinical study aimed to evaluate the effectiveness of low-level laser therapy in patients with temporomandibular disorders (TMD), specifically disc displacement with reduction and myalgia. The study compared laser therapy with a soft diet approach to determine whether laser treatment provides additional benefits in reducing pain and improving jaw function
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were assigned to one of two parallel groups: a low-level laser therapy group or a soft diet group. Outcomes were assessed at baseline, after completion of treatment sessions, and during follow-up evaluations.
| Arm | Type | Receives |
|---|---|---|
| Low Level Laser Therapy | Active comparator | Other: Low Level Laser TherapyParticipants in this group received low-level laser therapy applied to the temporomandibular joint region according to the predefined treatment protocol. Laser therapy was administered for 2 minutes per joint over 9 treatment sessions. Patients were also advised to follow a soft diet during the treatment period. |
| soft diet group | Other | Other: Dietary SupplementSoft Diet Group: Participants in this group did not receive laser therapy and were instructed to follow a soft diet during the study period. This group served as the comparison group for evaluating treatment outcomes. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of disc displacement with reduction (DDwR) and myalgia according to DC/TMD criteria Presence of temporomandibular joint pain and functional limitation Patients aged 18 years and older No previous temporomandibular joint (TMJ) treatment Absence of systemic diseases Willingness to participate and provide informed consent
Key exclusion criteria (1 listed)
- History of previous TMJ treatment (e.g., conservative or surgical treatment) Congenital or inflammatory joint disease Severe systemic diseases Edentulous patients Children and adolescents in the active growth period Acute trauma history involving the TMJ region Inability or unwillingness to complete follow-up visits
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 TherapyParticipants received low-level laser therapy applied to the temporomandibular joint region in addition to soft diet recommendations. Treatment was performed in 9 sessions according to the predefined laser protocol. Participants followed a soft diet regimen without receiving laser therapy and served as the comparison group. | Other | Low Level Laser Therapy |
| Dietary SupplementParticipants in this group did not receive laser therapy and were instructed to follow a soft diet during the study period. This group served as the comparison group for evaluating treatment outcomes. | Other | soft diet group |
Primary outcome
Change in temporomandibular pain intensity measured by the Visual Analog Scale (VAS) from baseline to the end of treatment and follow-up
Time frame: 6 month
Change in temporomandibular pain intensity was assessed using the Visual Analog Scale (VAS) from baseline to the end of treatment and follow-up. The Visual Analog Scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores represent greater pain severity.
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 15 May 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be publicly shared due to privacy and confidentiality considerations related to patient data
Related trials for Myalgia of Mastication Muscle
RecruitingObservational study
Occlusal Equilibration vs. Sham Therapies for TMDs: Post-Trial Follow-up (OEST)
Temporomandibular Disorders (TMD), Myalgia of Mastication Muscle
Enrolling by invitationObservational study
Botulinum Toxin in the Management of Temporo-mandibular Related Myalgia: a Prospective Study
TMD/Orofacial Pain, Myalgia of Mastication Muscle
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Dietary Supplement in people with Myalgia of Mastication Muscle, run by Karadeniz Technical 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 1 inclusion and 1 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 15 May 2026. 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?
Change in temporomandibular pain intensity measured by the Visual Analog Scale (VAS) from baseline to the end of treatment and follow-up (time frame: 6 month). 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 15 May 2026.