Temporomandibular Joint Dysfunction SyndromeNCT06495788
Effect of High-intensity Laser Therapy on Patients With Myogenic Temporomandibular Joint Dysfunction
A study testing High-intensity laser therapy (HILT) in people with Temporomandibular Joint Dysfunction Syndrome, run by Cairo University.
Trial summary
This study will be conducted to investigate the effect of high-intensity laser therapy on the temporalis and masseter muscles activity in patients with myogenic temporomandibular joint dysfunction. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Dysfunction Syndrome
- What is being tested?
- High-intensity laser therapy (HILT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 12 Jul 2024to 20 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients from both gender with unilateral myogenic temporomandibular dysfunction (TMD) with trismus diagnosed and referred from maxillofacial specialist.
- Aged between 20 to 45 years old .
- Visual analogue scale (VAS) score >3 for unilateral myogenic pain of the temporomandibular joint (TMJ).
- Pain lasting at least 3 months.
- Patients were diagnosed as unilateral myogenic pain.
Who cannot join
- Previous TMJ surgery.
- History of jaw dislocation.
- History of jaw fracture.
- Previous therapy with occlusal splint.
- Concomitant therapy of bruxism.
- Presence of removable oral prosthesis.
Show all 19Show fewer
- Metal implants in the skull.
- Presence of hearing aids.
- Malignancy.
- Pregnancy.
- Diabetic patients.
- Hypertensive patients.
- Systemic rheumatologic disease
- Systemic infection.
- Inserted cardiac pacemaker.
- Presence of coagulation disorders.
- Trigeminal neuritis.
- Cognitive dysfunction.
- Bilateral TMD.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of High-intensity Laser Therapy on Temporalis and Masseter Muscles Activity in Patients With Myogenic Temporomandibular Joint Dysfunction
This study will be conducted to investigate the effect of high-intensity laser therapy on the temporalis and masseter muscles activity in patients with myogenic temporomandibular joint dysfunction.
Read the detailed description
Temporomandibular joint dysfunction (TMD) is one of the problems that affect the quality of lifestyle through the presence of pain around the joint radiated in the face, neck, or shoulders muscles and a decrease in function of the temporomandibular joint that leads to difficulty in mastication, swallowing, earaches, dizziness, and hearing problems may sometimes be associated with TMD.
High-intensity laser therapy (HILT) is a laser with a wavelength of 1064 nm and has recently been used in the treatment of musculoskeletal diseases. Its primary effect is the analgesic effect and reactive vasodilation by affecting the cutaneous nerve endings. Another mechanism of action is based on tissue stimulation. This stimulation occurs at the level of cells, vascular tissue, interstitial tissue, and the immune system. It increases regeneration and beta-endorphin release by inducing protein synthesis in synovial fluid, thus exerting analgesic and anti-inflammatory effects.
Since there is a lack of literature studying the effect of HILT on masseter and temporalis muscles activity in patients with myogenic TMD so, this study may provide a baseline for a new technique in rehabilitation intervention in patients with myogenic TMD.
- Being tested
- High-intensity laser therapy (HILT), placebo high-intensity laser therapy
- Medical subject headings
- Temporomandibular Joint Dysfunction Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity laser therapy (HILT)Device
- Pulsed high-intensity laser therapy (HILT) will be applied 3 sessions per week for 8 weeks with pulsed emission (1064 nm), very high peak power (3 kW), a short duration (120-150 ms), and low frequency (10-40 Hz).The probe is fixed vertically at 90° to the most painful points while the patients sit on a chair and wear safety eyewear.
- Conventional treatment ( 3 days per week for 8 weeks).: in the form of
- Hot pad: It will be used over the temporomandibular joint (TMJ) for 5 minutes at the beginning of each session.
- Ultrasound therapy (US): it will be applied over the TMJ with pulsed intensity of 1.0 W/cm2 at a 1MHz frequency for 5 min/session.
- TENS: one electrode is placed over the TMJ and the other just above the mandibular angle. it will be applied with a low frequency of 50 HZ, tolerable intensity for 15 minutes.
- Exercise therapy: anterior, medial and lateral glide of the mandible. Each glide will be done 10-15 repetitions, 5-6 times in a session, 10 minutes as a total.
placebo high-intensity laser therapyDevice
The same treatment procedure will be applied in the placebo group as in the experimental group, but the laser device is turned off during applications, in addition to the conventional treatment in the form of hot pad, US, TENS, and exercise therapy.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity laser therapy group | Experimental | Patients will receive pulsed high-intensity laser therapy in addition to conventional treatment Receives: Device: High-intensity laser therapy (HILT) |
| placebo high-intensity laser therapy group | Placebo comparator | Patients will receive placebo high-intensity laser therapy in addition to conventional treatment Receives: Device: placebo high-intensity laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temporalis and masseter muscles activity
The surface electromyography device (sEMG) (MyoTrac Infiniti 2 Channel sEMG w/Rehab Suite \& Continence Suite-T9855; Quebec, Canada) at 60 Hz and Infiniti software will be used to record masseter and temporalis activity before and after the treatment program.
patients will be instructed to clench to help the researcher to find the appropriate muscle location by their prominence. Pregelled and self-adhesive electrodes with 3 surface leads (2 recording, 1 reference) will be used. The electrode is placed over the anterosuperior to the angle of the mandible on both sides for recording masseter muscle, while for temporalis muscle, electrodes are placed above a line drawn from upper earline to canthus of the eye with interelectrode distance which is 8mm.
sEMG Signal Analysis: Mean, median frequency, SD, root mean square, minimum, maximum, and range of muscle activity (μV) will be calculated.
Measured: within 8 weeks
Pain intensity
Visual analogue scale (VAS), a valid and reliable measure of pain intensity will be used to measure pain intensity for all participants in both groups before and after treatment. All participants will be asked to mark their pain level on a 10-cm line that corresponds to their pain intensity on the line between "0", representing "no pain", and "10", representing "the worst pain.
Measured: within 8 weeks
Range of mouth opening
Flexible millimeter ruler will be used to measure mouth opening for all participants in both groups before and after the treatment. Mouth opening will be evaluated by asking the patient to open their mouth as wide as possible and measuring the distance between the edges of the frontal incisors with a ruler at the incisal edge of the maxillary central incisor that is the most vertically oriented and measured vertically to the labio-incisal edge of the opposing mandibular incisor to assess the pre-post therapy maximum mouth opening (MMO). Studies reported range has been as wide as 32-62 mm (for both sexes)
Measured: within 8 weeks
Secondary outcomes (1)
Limitation of Daily Function Temporomandibular Dysfunction questionnaire (LDF-TMDQ)
Arabic version of LDF-TMDQ will be used to assess the limitation of daily function in patients with temporomandibular dysfunction in both groups before and after the treatment program. It consists of 10 items. For each item, the subject chose any one of five levels on a numerical rating scale from no problem at all (0) to extremely difficult (4 points). The total score of the 10 items, ranging from 0-40 points, will be analyzed. Internal consistency of the total scores appeared to be good at 0.78 for the 10 items.
Measured: within 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start12 Jul 2024 (estimated)
- Primary completion20 Nov 2024 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint Dysfunction SyndromeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohaya Ahmed Mohamed, Cairo University
- Investigators
- Amir Saleh, professor, Study chair, Cairo UniversityNaglaa Awais, PHD, Study director, Cairo UniversityHala Hazzaa, professor, Study director, Al-Azhar UniversityYasser Lasheen, PHD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495788
- Sponsor's protocol ID
- P.T.REC/012/004882
- Status last verified
- Jul 2024
- First submitted
- 3 Jul 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-intensity Laser Therapy on Temporalis and Masseter Muscles Activity in Patients With Myogenic Temporomandibular Joint Dysfunction
- ClinicalTrials.gov ID
- NCT06495788
- Acronym / sponsor ID
- P.T.REC/012/004882
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Jul 2024 (estimated)
- Primary completion
- 20 Nov 2024 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 11 Jul 2024 (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 study will be conducted to investigate the effect of high-intensity laser therapy on the temporalis and masseter muscles activity in patients with myogenic temporomandibular joint dysfunction.
Detailed description
Temporomandibular joint dysfunction (TMD) is one of the problems that affect the quality of lifestyle through the presence of pain around the joint radiated in the face, neck, or shoulders muscles and a decrease in function of the temporomandibular joint that leads to difficulty in mastication, swallowing, earaches, dizziness, and hearing problems may sometimes be associated with TMD.
High-intensity laser therapy (HILT) is a laser with a wavelength of 1064 nm and has recently been used in the treatment of musculoskeletal diseases. Its primary effect is the analgesic effect and reactive vasodilation by affecting the cutaneous nerve endings. Another mechanism of action is based on tissue stimulation. This stimulation occurs at the level of cells, vascular tissue, interstitial tissue, and the immune system. It increases regeneration and beta-endorphin release by inducing protein synthesis in synovial fluid, thus exerting analgesic and anti-inflammatory effects.
Since there is a lack of literature studying the effect of HILT on masseter and temporalis muscles activity in patients with myogenic TMD so, this study may provide a baseline for a new technique in rehabilitation intervention in patients with myogenic TMD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-intensity laser therapy group | Experimental | Device: High-intensity laser therapy (HILT)Patients will receive pulsed high-intensity laser therapy in addition to conventional treatment |
| placebo high-intensity laser therapy group | Placebo comparator | Device: placebo high-intensity laser therapyPatients will receive placebo high-intensity laser therapy in addition to conventional treatment |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients from both gender with unilateral myogenic temporomandibular dysfunction (TMD) with trismus diagnosed and referred from maxillofacial specialist.
- Aged between 20 to 45 years old .
- Visual analogue scale (VAS) score >3 for unilateral myogenic pain of the temporomandibular joint (TMJ).
- Pain lasting at least 3 months.
- Patients were diagnosed as unilateral myogenic pain.
Key exclusion criteria (19 listed)
- Previous TMJ surgery.
- History of jaw dislocation.
- History of jaw fracture.
- Previous therapy with occlusal splint.
- Concomitant therapy of bruxism.
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 |
|---|---|---|
| High-intensity laser therapy (HILT)* Pulsed high-intensity laser therapy (HILT) will be applied 3 sessions per week for 8 weeks with pulsed emission (1064 nm), very high peak power (3 kW), a short duration (120-150 ms), and low frequency (10-40 Hz).The probe is fixed vertically at 90° to the most painful points while the patients sit on a chair and wear safety eyewear. * Conventional treatment ( 3 days per week for 8 weeks).: in the form of * Hot pad: It will be used over the temporomandibular joint (TMJ) for 5 minutes at the beginning of each session. * Ultrasound therapy (US): it will be applied over the TMJ with pulsed intensity of 1.0 W/cm2 at a 1MHz frequency for 5 min/session. * TENS: one electrode is placed over the TMJ and the other just above the mandibular angle. it will be applied with a low frequency of 50 HZ, tolerable intensity for 15 minutes. * Exercise therapy: anterior, medial and lateral glide of the mandible. Each glide will be done 10-15 repetitions, 5-6 times in a session, 10 minutes as a total. | Device | High-intensity laser therapy group |
| placebo high-intensity laser therapyThe same treatment procedure will be applied in the placebo group as in the experimental group, but the laser device is turned off during applications, in addition to the conventional treatment in the form of hot pad, US, TENS, and exercise therapy. | Device | placebo high-intensity laser therapy group |
Primary outcome
Temporalis and masseter muscles activity
Time frame: within 8 weeks
The surface electromyography device (sEMG) (MyoTrac Infiniti 2 Channel sEMG w/Rehab Suite \& Continence Suite-T9855; Quebec, Canada) at 60 Hz and Infiniti software will be used to record masseter and temporalis activity before and after the treatment program. patients will be instructed to clench to help the researcher to find the appropriate muscle location by their prominence. Pregelled and self-adhesive electrodes with 3 surface leads (2 recording, 1 reference) will be used. The electrode is placed over the anterosuperior to the angle of the mandible on both sides for recording masseter muscle, while for temporalis muscle, electrodes are placed above a line drawn from upper earline to canthus of the eye with interelectrode distance which is 8mm. sEMG Signal Analysis: Mean, median frequency, SD, root mean square, minimum, maximum, and range of muscle activity (μV) will be calculated.
Pain intensity
Time frame: within 8 weeks
Visual analogue scale (VAS), a valid and reliable measure of pain intensity will be used to measure pain intensity for all participants in both groups before and after treatment. All participants will be asked to mark their pain level on a 10-cm line that corresponds to their pain intensity on the line between "0", representing "no pain", and "10", representing "the worst pain.
Range of mouth opening
Time frame: within 8 weeks
Flexible millimeter ruler will be used to measure mouth opening for all participants in both groups before and after the treatment. Mouth opening will be evaluated by asking the patient to open their mouth as wide as possible and measuring the distance between the edges of the frontal incisors with a ruler at the incisal edge of the maxillary central incisor that is the most vertically oriented and measured vertically to the labio-incisal edge of the opposing mandibular incisor to assess the pre-post therapy maximum mouth opening (MMO). Studies reported range has been as wide as 32-62 mm (for both sexes)
1 secondary outcome
Limitation of Daily Function Temporomandibular Dysfunction questionnaire (LDF-TMDQ)
Time frame: within 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Individual participant dataSharing planned: Yes
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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.
Amir Saleh, professor study chair
Cairo University
Naglaa Awais, PHD study director
Cairo University
Hala Hazzaa, professor study director
Al-Azhar University
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity laser therapy (HILT) in people with Temporomandibular Joint Dysfunction Syndrome, 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 5 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 11 Jul 2024. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohaya Mohamed, PHD (+201065150305, Mohayaahmed88@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temporalis and masseter muscles activity (time frame: within 8 weeks). The study lists 3 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 11 Jul 2024.