Temporomandibular Joint Dysfunction SyndromeRCTNCT05901701
Efficacy of Low Level LASER Therapy in Treating Temporomandibular Muscle Disorders
A study testing Low Level LASER therapy and Hard occlusal splint in people with Temporomandibular Joint Dysfunction Syndrome, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aimed to evaluate the sustainability of the efficacy of using low level laser therapy and CAD/CAM Michigan splint in improving the range of mandibular movements, muscle activity and reducing the pain. Read more about this study
- Who is it for?
- Ages 35 to 55 years, women only
- Conditions the study is for
- Temporomandibular Joint Dysfunction Syndrome
- What is being tested?
- Low Level LASER therapy and Hard occlusal splint
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Nov 2022to 27 May 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 35 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- pregnant females, breast feeders, patients having pacemakers, heart disease, tumors, general connective tissue disease e.g., Rheumatoid arthritis, psychiatric disorders, skeletal morphology as class II or III, TMJ clicking sounds, local skin infection over the masseter or temporalis, symptoms that may be referred to other disorders of orofacial region (tooth ache, trigeminal neuralgia, migraine), or patients using medications such as Muscle relaxant, Steroids, Dopamine precursors like L dopa and Aminoglycoside
- Vulnerable groups (prisoners, mental disorders, patients not capable of decision making).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Low-Level Laser Therapy Versus CAD/CAM Michigan Splint on Patients With Temporomandibular Muscle Disorders Randomized Clinical Trial
This study aimed to evaluate the sustainability of the efficacy of using low level laser therapy and CAD/CAM Michigan splint in improving the range of mandibular movements, muscle activity and reducing the pain.
Read the detailed description
56 female patients were randomly divided into two groups, Group A: Patients received applications of low-level laser therapy using semiconductor InGaAsp diode LASER type 940 nm with continuous mode of operation, with time of application 180 sec per session for 12 sessions. Group B: Patients received hard occlusal splints (Michigan splints) of 2 mm thickness constructed on their upper teeth, the hard occlusal splint was 3D digitally printed. ARCUS digma facebow was used to evaluate the range of mandibular movements affected from TMJ problems. The opening measurements of the patient were taken using a millimeter ruler. Electromyogram (EMG) was used to evaluate muscle activity. Visual analogue scale (VAS) was used to evaluate the pain intensity. All was done before the beginning of the treatment at three and six months follow up period.
- Being tested
- Low Level LASER therapy, Hard occlusal splint
- Keywords
- Low level LASER therapy, Michigan splint, Electromyogram, Myofascial pain
- 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.
Low Level LASER therapyRadiation
using semiconductor InGaAsp diode LASER type 940 nm with continuous mode of operation, with time of application 180 sec per session for 12 sessions.
Hard occlusal splintDevice
Also called Michigan splint
2 mm thickness occlusal splint constructed over the maxillary arch using CAD/CAM technology.
| Study group | Role | What they receive |
|---|---|---|
| LASER group | Experimental | Group A: Patients received applications of low-level laser therapy using semiconductor InGaAsp diode LASER type 940 nm with continuous mode of operation, with time of application 180 sec per session for 12 sessions. Receives: Radiation: Low Level LASER therapy |
| Splint group | Active comparator | Group B: Patients received hard occlusal splints (Michigan splints), used for 3 months during sleeping then the patient stops using it and told to only wear it if discomfort return usually during stressful times. Receives: Device: Hard occlusal splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyographic muscle activity
The change in muscle activity was assessed using EMG in terms of Microvolt
Measured: Measured 3 times through 6 months from the beginning of the treatment. (0,3,6 months)
Range of mandibular movement
The increase in the range of movement measured using ARCUS digma in terms of angular inclination.
Measured: Measured 3 times through 6 months from the beginning of the treatment. (0,3,6 months)
Secondary outcomes (2)
Pain intensity
The degree of pain is assessed using a 10 cm scale (VAS)
Measured: Measured 3 times through 6 months from the beginning of the treatment. (0,3,6 months)
Mouth opening
degree of mouth opening in cm using ruler
Measured: Measured 3 times through 6 months from the beginning of the treatment. (0,3,6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start20 Nov 2022
- Primary completion20 May 2023
- Study completion27 May 2023
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 Ain Shams 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
- Model description
- Group A: Patients received applications of low-level laser therapy. Group B: Patients received hard occlusal splints (Michigan splints).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rami M Ghali, professor, Study director, oral and maxillofacial prosthodontics department, faculty of dentistry, Ain Shams UniversityAmany M Farahat, PhD, Principal investigator, Oral and Maxillofacial prosthodontics department, faculty of dentistry, Ain Shams UniversityDina E Bahig, PhD, Principal investigator, Oral and Maxillofacial prosthodontics department, faculty of dentistry, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05901701
- Sponsor's protocol ID
- FDASU-Rec IR112207
- Acronym
- RCT
- Status last verified
- Nov 2022
- First submitted
- 4 Jun 2023
- Last updated
- 13 Jun 2023
- 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 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-Level Laser Therapy Versus CAD/CAM Michigan Splint on Patients With Temporomandibular Muscle Disorders Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05901701
- Acronym / sponsor ID
- RCT / FDASU-Rec IR112207
- Keywords
- Low level LASER therapy, Michigan splint, Electromyogram, Myofascial pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Nov 2022 (actual)
- Primary completion
- 20 May 2023 (actual)
- Study completion
- 27 May 2023 (actual)
- First posted
- 13 Jun 2023 (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 aimed to evaluate the sustainability of the efficacy of using low level laser therapy and CAD/CAM Michigan splint in improving the range of mandibular movements, muscle activity and reducing the pain.
Detailed description
56 female patients were randomly divided into two groups, Group A: Patients received applications of low-level laser therapy using semiconductor InGaAsp diode LASER type 940 nm with continuous mode of operation, with time of application 180 sec per session for 12 sessions. Group B: Patients received hard occlusal splints (Michigan splints) of 2 mm thickness constructed on their upper teeth, the hard occlusal splint was 3D digitally printed. ARCUS digma facebow was used to evaluate the range of mandibular movements affected from TMJ problems. The opening measurements of the patient were taken using a millimeter ruler. Electromyogram (EMG) was used to evaluate muscle activity. Visual analogue scale (VAS) was used to evaluate the pain intensity. All was done before the beginning of the treatment at three and six months follow up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Group A: Patients received applications of low-level laser therapy. Group B: Patients received hard occlusal splints (Michigan splints).
| Arm | Type | Receives |
|---|---|---|
| LASER group | Experimental | Radiation: Low Level LASER therapyGroup A: Patients received applications of low-level laser therapy using semiconductor InGaAsp diode LASER type 940 nm with continuous mode of operation, with time of application 180 sec per session for 12 sessions. |
| Splint group | Active comparator | Device: Hard occlusal splintGroup B: Patients received hard occlusal splints (Michigan splints), used for 3 months during sleeping then the patient stops using it and told to only wear it if discomfort return usually during stressful times. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- pregnant females, breast feeders, patients having pacemakers, heart disease, tumors, general connective tissue disease e.g., Rheumatoid arthritis, psychiatric disorders, skeletal morphology as class II or III, TMJ clicking sounds, local skin infection over the masseter or temporalis, symptoms that may be referred to other disorders of orofacial region (tooth ache, trigeminal neuralgia, migraine), or patients using medications such as Muscle relaxant, Steroids, Dopamine precursors like L dopa and Aminoglycoside
- Vulnerable groups (prisoners, mental disorders, patients not capable of decision making).
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 therapyusing semiconductor InGaAsp diode LASER type 940 nm with continuous mode of operation, with time of application 180 sec per session for 12 sessions. | Radiation | LASER group |
| Hard occlusal splintAlso: Michigan splint2 mm thickness occlusal splint constructed over the maxillary arch using CAD/CAM technology. | Device | Splint group |
Primary outcome
Electromyographic muscle activity
Time frame: Measured 3 times through 6 months from the beginning of the treatment. (0,3,6 months)
The change in muscle activity was assessed using EMG in terms of Microvolt
Range of mandibular movement
Time frame: Measured 3 times through 6 months from the beginning of the treatment. (0,3,6 months)
The increase in the range of movement measured using ARCUS digma in terms of angular inclination.
2 secondary outcomes
Pain intensity
Time frame: Measured 3 times through 6 months from the beginning of the treatment. (0,3,6 months)
Mouth opening
Time frame: Measured 3 times through 6 months from the beginning of the treatment. (0,3,6 months)
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 13 Jun 2023.
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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.
Rami M Ghali, professor study director
oral and maxillofacial prosthodontics department, faculty of dentistry, Ain Shams University
Amany M Farahat, PhD principal investigator
Oral and Maxillofacial prosthodontics department, faculty of dentistry, Ain Shams University
Dina E Bahig, PhD principal investigator
Oral and Maxillofacial prosthodontics department, faculty of dentistry, Ain Shams 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 Hard occlusal splint in people with Temporomandibular Joint Dysfunction Syndrome, run by Ain Shams University at 1 site in Egypt.
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 0 inclusion and 2 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 13 Jun 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 Egypt. 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?
Electromyographic muscle activity (time frame: Measured 3 times through 6 months from the beginning of the treatment. (0,3,6 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 13 Jun 2023.