TMDNCT05620758
Laser Therapy and Temporomandibular Disorders
A study testing Nd YAG laser, diode laser (980 nm) and diode laser (940 nm) in people with TMD, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
TMD involves a set of multiple clinical manifestations where the pain is prevalent. Treatment ideally should be noninvasive and innocuous such as photobiomodulation Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- TMD
- What is being tested?
- Nd YAG laser, diode laser (980 nm) and diode laser (940 nm)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Nov 2022to 30 Jan 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Pain at TMJ area.
- Pain at masseter and temporalis muscles.
- Age ranges between 20 and 40 years old.
- Presence of full or nearly full complement of natural teeth
Who cannot join
- Patients who have radiographic evidence of degenerative conditions of TMJ.
- Patients under current dental or physical therapy that could affect TMD.
- History of recent trauma.
- The presence of systemic diseases (i.e. rheumatoid arthritis, osteoarthritis).
- Pregnant and lactating females
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria Faculty of Dentistry
Alexandria
Nermeen A Rady, phd, Abdallah.abdelaty@gmail.com
Nermeen A Rady, Phd
About this study
Official title: Clinical Effectiveness of a Laser Therapy in Patients With Temporomandibular Disorders (A Randomized Clinical Trial)
TMD involves a set of multiple clinical manifestations where the pain is prevalent. Treatment ideally should be noninvasive and innocuous such as photobiomodulation
- Conditions
- TMD
- Being tested
- Nd YAG laser, diode laser (980 nm), diode laser (940 nm), diode laser (660 nm), diode laser (635 nm)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nd YAG laserOther
patients from those diagnosed with TMD will receive Nd YAG laser 1064 nm
diode laser (980 nm)Other
patients from those diagnosed with TMD will receive a diode laser (980 nm)
diode laser (940 nm)Other
patients from those diagnosed with TMD will receive a diode laser (940 nm)
diode laser (660 nm)Other
patients from those diagnosed with TMD will receive a diode laser (660 nm)
diode laser (635 nm)Other
patients from those diagnosed with TMD will receive a diode laser (635 nm)
| Study group | Role | What they receive |
|---|---|---|
| Nd YAG laser | Experimental | Not described Receives: Other: Nd YAG laser |
| Diode laser 980 nm | Experimental | Not described Receives: Other: diode laser (980 nm) |
| Diode laser 940 nm | Experimental | Not described Receives: Other: diode laser (940 nm) |
| Diode laser 660 nm | Experimental | Not described Receives: Other: diode laser (660 nm) |
| Diode laser 635 nm | Experimental | Not described Receives: Other: diode laser (635 nm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain
Visual analogue scale of pain (VAS),using a 0-10-point scale 0 score means no pain" and score 10 means "worst pain
Measured: Baseline and 1 month
Chaneg in pressure pain threshold
The pressure pain threshold measurements for the trapezius, infraspinatus, and extensor carpi radialis muscles were performed at the center of the upper trapezius, at a position 2-3 fingers below the center of the spine of scapula, and at a position 3-4 fingers below the lateral epicondyle of the humerus, respectively. The pressure pain threshold of the extensor indicis proprius was measured by pressing toward the medial side of the radius from a position 3 fingers above the radial styloid process. The investigator placed the digital pressure algometer on a site to be inspected and pressed against the tester in a vertical direction while increasing the force at a constant rate of 1 kg/cm2. The investigator instructed the subjects to express pain either by saying "ouch" or raising their hands when only slight pain was felt. After all 8 muscles were investigated, the subjects were allowed to rest for 5 min. This procedure was repeated a total of 3 times.
Measured: Baseline and 1 month
Change in Oral-health Related Quality of life (OHRQoL)
The OHIP-14 has 14 questions related to the evaluation of OHRQoL. The responses were recorded in a 5-point Likert scale ranging from never to very often (score is 0 to 4). Then, we calculated the total scores of all domains, and a higher score indicated poor OHRQoL. The highest possible total score of all the OHIP-14 domains is 56
Measured: Baseline and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start30 Nov 2022
- Primary completion30 Jan 2023 (estimated)
- Study completion30 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMDStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620758
- Sponsor's protocol ID
- TMD_Laser_2022
- Status last verified
- Dec 2022
- First submitted
- 10 Nov 2022
- Last updated
- 14 Dec 2022
- 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 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of a Laser Therapy in Patients With Temporomandibular Disorders (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT05620758
- Acronym / sponsor ID
- TMD_Laser_2022
- Conditions
- TMD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 30 Jan 2023 (estimated)
- Study completion
- 30 Jan 2023 (estimated)
- First posted
- 17 Nov 2022 (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.
TMD involves a set of multiple clinical manifestations where the pain is prevalent. Treatment ideally should be noninvasive and innocuous such as photobiomodulation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Nd YAG laser | Experimental | Other: Nd YAG laser |
| Diode laser 980 nm | Experimental | Other: diode laser (980 nm) |
| Diode laser 940 nm | Experimental | Other: diode laser (940 nm) |
| Diode laser 660 nm | Experimental | Other: diode laser (660 nm) |
| Diode laser 635 nm | Experimental | Other: diode laser (635 nm) |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pain at TMJ area.
- Pain at masseter and temporalis muscles.
- Age ranges between 20 and 40 years old.
- Presence of full or nearly full complement of natural teeth
Key exclusion criteria (5 listed)
- Patients who have radiographic evidence of degenerative conditions of TMJ.
- Patients under current dental or physical therapy that could affect TMD.
- History of recent trauma.
- The presence of systemic diseases (i.e. rheumatoid arthritis, osteoarthritis).
- Pregnant and lactating females
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 |
|---|---|---|
| Nd YAG laserpatients from those diagnosed with TMD will receive Nd YAG laser 1064 nm | Other | Nd YAG laser |
| diode laser (980 nm)patients from those diagnosed with TMD will receive a diode laser (980 nm) | Other | Diode laser 980 nm |
| diode laser (940 nm)patients from those diagnosed with TMD will receive a diode laser (940 nm) | Other | Diode laser 940 nm |
| diode laser (660 nm)patients from those diagnosed with TMD will receive a diode laser (660 nm) | Other | Diode laser 660 nm |
| diode laser (635 nm)patients from those diagnosed with TMD will receive a diode laser (635 nm) | Other | Diode laser 635 nm |
Primary outcome
Change in Pain
Time frame: Baseline and 1 month
Visual analogue scale of pain (VAS),using a 0-10-point scale 0 score means no pain" and score 10 means "worst pain
Chaneg in pressure pain threshold
Time frame: Baseline and 1 month
The pressure pain threshold measurements for the trapezius, infraspinatus, and extensor carpi radialis muscles were performed at the center of the upper trapezius, at a position 2-3 fingers below the center of the spine of scapula, and at a position 3-4 fingers below the lateral epicondyle of the humerus, respectively. The pressure pain threshold of the extensor indicis proprius was measured by pressing toward the medial side of the radius from a position 3 fingers above the radial styloid process. The investigator placed the digital pressure algometer on a site to be inspected and pressed against the tester in a vertical direction while increasing the force at a constant rate of 1 kg/cm2. The investigator instructed the subjects to express pain either by saying "ouch" or raising their hands when only slight pain was felt. After all 8 muscles were investigated, the subjects were allowed to rest for 5 min. This procedure was repeated a total of 3 times.
Change in Oral-health Related Quality of life (OHRQoL)
Time frame: Baseline and 1 month
The OHIP-14 has 14 questions related to the evaluation of OHRQoL. The responses were recorded in a 5-point Likert scale ranging from never to very often (score is 0 to 4). Then, we calculated the total scores of all domains, and a higher score indicated poor OHRQoL. The highest possible total score of all the OHIP-14 domains is 56
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nd YAG laser, diode laser (980 nm) and diode laser (940 nm) in people with TMD, run by Hams Hamed Abdelrahman 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 4 inclusion and 5 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 14 Dec 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nermeen A Rady, phd (01223349577, nermeen.rady@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain (time frame: Baseline and 1 month). 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 14 Dec 2022; AzTrials last refreshed its copy on 3 Nov 2026.