LaserNCT06999239
Evaluation of the Effect of Laser Therapy on Lateral Pterygoid Muscle in Patients With Wilke's Stage I and II Temporomandibular Disorders (TMD): Case Series Study
A study testing laser therapy in TMD in people with Laser and Temporomandibular Joint Disorders, run by Cairo University.
Trial summary
The purpose of this study will be to evaluate the effect of laser therapy on lateral pterygoid muscle in patients with Wilke's stage I and II temporomandibular disorders (TMD). Read more about this study
- Who is it for?
- Ages 16 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Laser, Temporomandibular Joint Disorders, Lateral Pterygoid Muscle
- What is being tested?
- laser therapy in TMD
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients age between 16-50 years with no sex predilection.
- Patients who will be free from any systemic diseases that affect temporomandibular joint.
- Patients who will be diagnosed with wilk's stage I and II temporomandibular disorders (TMD).
- Patients who will be ready to give informed consent.
Who cannot join
- Patients with previous temporo-mandibular surgeries.
- Patients with previous facial fracture.
- Patients who will be under another type of treatment for TMD (e.g., occlusal splints, pharmacological drugs, or head and neck surgery).
- Patients who will not attend the proposed treatment sessions or follow-up visits.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of this study will be to evaluate the effect of laser therapy on lateral pterygoid muscle in patients with Wilke's stage I and II temporomandibular disorders (TMD).
- Being tested
- laser therapy in TMD
- Keywords
- laser therapy, lateral pterygoid muscle, Wilke's, stage I and II, TMD.
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser therapy in TMDProcedure or surgery
In this study patients will receive the Low-level laser therapy with a 635 nm wavelength diode laser (Lasotronix, Diode Laser DiodeLX model SMART M; Zytnia, Piaseczno, Poland) with 200 mW in a continuous mode, using a handpiece with a cylindrical applicator with a diameter of 8 mm in contact mode extra-orally, fiber-optic applicator with a diameter of 8 mm in contact mode intraorally, with a power density of 400 mW/cm2, delivering 10-12 J/cm2 on each application point, over a period of 20 sec.
There are two methods for examination of lateral pterygoid muscle: digital palpation and functional manipulation.
For digital palpation of lateral pterygoid muscle, we place our index finger or tip of our little finger in the vestibular area adjacent to the maxillary third molar.
Functional manipulation of the inferior head of lateral pterygoid muscle: It is best accomplished by having the patient make a protrusive movement against resistance to contract it since this muscle is the primary pro
| Study group | Role | What they receive |
|---|---|---|
| one arm(case series0 | Experimental | Not described Receives: Procedure: laser therapy in TMD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain: will be obtained by Visual analogue scale (VAS).
Pain: will be obtained by Visual analogue scale (VAS).
Measured: pain will be measured : 1.day1 before the start of laser therapy, 2.week 1 3. week2 4.week 3 5. week 4 6.one month later 7. 3 months later.
Secondary outcomes (1)
Mouth opening, lateral protrusive movement: will be obtained by a caliper.
Mouth opening, lateral protrusive movement: will be obtained by a caliper.
Measured: Mouth opening, lateral protrusive movement will be measured : 1.day1 before the start of laser therapy, 2.week 1 3. week2 4.week 3 5. week 4 6.one month later 7. 3 months later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study startJul 2025 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaserStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliaa ibrahim fathy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06999239
- Sponsor's protocol ID
- Treatment of TMD by laser
- Status last verified
- Jun 2025
- First submitted
- 9 May 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Laser Therapy on Lateral Pterygoid Muscle in Patients With Wilke's Stage I and II Temporomandibular Disorders (TMD): Case Series Study
- ClinicalTrials.gov ID
- NCT06999239
- Acronym / sponsor ID
- Treatment of TMD by laser
- Keywords
- laser therapy, lateral pterygoid muscle, Wilke's, stage I and II, TMD.
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 31 May 2025 (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.
The purpose of this study will be to evaluate the effect of laser therapy on lateral pterygoid muscle in patients with Wilke's stage I and II temporomandibular disorders (TMD).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one arm(case series0 | Experimental | Procedure: laser therapy in TMD |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients age between 16-50 years with no sex predilection.
- Patients who will be free from any systemic diseases that affect temporomandibular joint.
- Patients who will be diagnosed with wilk's stage I and II temporomandibular disorders (TMD).
- Patients who will be ready to give informed consent.
Key exclusion criteria (4 listed)
- Patients with previous temporo-mandibular surgeries.
- Patients with previous facial fracture.
- Patients who will be under another type of treatment for TMD (e.g., occlusal splints, pharmacological drugs, or head and neck surgery).
- Patients who will not attend the proposed treatment sessions or 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 |
|---|---|---|
| laser therapy in TMDIn this study patients will receive the Low-level laser therapy with a 635 nm wavelength diode laser (Lasotronix, Diode Laser DiodeLX model SMART M; Zytnia, Piaseczno, Poland) with 200 mW in a continuous mode, using a handpiece with a cylindrical applicator with a diameter of 8 mm in contact mode extra-orally, fiber-optic applicator with a diameter of 8 mm in contact mode intraorally, with a power density of 400 mW/cm2, delivering 10-12 J/cm2 on each application point, over a period of 20 sec. There are two methods for examination of lateral pterygoid muscle: digital palpation and functional manipulation. For digital palpation of lateral pterygoid muscle, we place our index finger or tip of our little finger in the vestibular area adjacent to the maxillary third molar. Functional manipulation of the inferior head of lateral pterygoid muscle: It is best accomplished by having the patient make a protrusive movement against resistance to contract it since this muscle is the primary pro | Procedure or surgery | one arm(case series0 |
Primary outcome
Pain: will be obtained by Visual analogue scale (VAS).
Time frame: pain will be measured : 1.day1 before the start of laser therapy, 2.week 1 3. week2 4.week 3 5. week 4 6.one month later 7. 3 months later.
Pain: will be obtained by Visual analogue scale (VAS).
1 secondary outcome
Mouth opening, lateral protrusive movement: will be obtained by a caliper.
Time frame: Mouth opening, lateral protrusive movement will be measured : 1.day1 before the start of laser therapy, 2.week 1 3. week2 4.week 3 5. week 4 6.one month later 7. 3 months later.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing laser therapy in TMD in people with Laser and Temporomandibular Joint Disorders, run by Cairo University.
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 4 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: opening soon, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact aliaa ibrahim fathy khalifa, B.D.S 2019 (01068111549, aliaa.ibrahim@dentistry.cu.edu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain: will be obtained by Visual analogue scale (VAS). (time frame: pain will be measured : 1.day1 before the start of laser therapy, 2.week 1 3. week2 4.week 3 5. week 4 6.one month later 7. 3 months later.). 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 13 Jun 2025.