Temporomandibular Joint DisordersNCT06763419
Internal Photobiomodulation For Management Of Temporomandibular Joint Internal Derangement
A study testing External low level laser therapy and Internal low level laser therapy in people with Temporomandibular Joint Disorders, run by Nourhan M.Aly at 1 site in Egypt.
Trial summary
Aim of the study was to compare the efficacy of internal versus external photobiomodulation (PBM) in the management of patients with TMJ internal derangements (TMJ-ID). Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- External low level laser therapy and Internal low level laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Dec 2024to 28 Feb 2025
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Painful click at temporomandibular joint (TMJ) area.
- Pain at the lateral pterygoid muscle.
- Presence of full or nearly full complement of natural teeth with acceptable occlusion
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.
- Presence of open bite.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry
Alexandria
Mariam Bahgat, PhD, +20 12 22882107, mariam.amin@alexu.edu.eg
About this study
Official title: Internal Photobiomodulation For Management Of Temporomandibular Joint Internal Derangement: A Randomized Clinical Trial
Aim of the study was to compare the efficacy of internal versus external photobiomodulation (PBM) in the management of patients with TMJ internal derangements (TMJ-ID).
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- External low level laser therapy, Internal low level laser therapy
- 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.
External low level laser therapyDevice
Patients received 8 sessions of external diode laser (635 nm).
Internal low level laser therapyDevice
Patients received 8 diode laser (635 nm) sessions applied internally
| Study group | Role | What they receive |
|---|---|---|
| External low level laser therapy | Experimental | Not described Receives: Device: External low level laser therapy |
| Internal low level laser therapy | Active comparator | Not described Receives: Device: Internal low level laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level assessment using Visual Analogue Scale
All patients will be evaluated subjectively through Visual Analogue Scale (VAS) to clinically assess the pain intensity with ratings between 0 for pain-free and 10 for maximum pain
Measured: after one month from the last laser session
Oral health-related quality of life using OHIP-TMD
Oral health-related quality of life will be assessed using OHIP-TMD, a 22-item temporomandibular disorder-specific version of the Oral Health Impact Profile (OHIP).
Each item in the OHIP-TMDs is scored on a Likert scale, often ranging from: 0 (Never) to 4 (Very often). For each respondent, the scores for all 22 items are summed to create a total score. The total score ranges from 0 to 88, where higher scores indicate a greater negative impact on oral health-related quality of life.
Measured: after one month from the last laser session
Maximum mouth opening evaluation using the Miller index
The Miller Index is calculated as a ratio of the observed maximum interincisal distance (distance between the edges of the upper and lower incisors when the mouth is fully open) to the patient's height. This provides a normalized measure of mouth opening relative to body stature.
Miller Index= Maximum Interincisal Distance (mm)/Height (cm)
Normal Range: A typical Miller Index is around 1.6 to 1.7 mm/cm in healthy individuals. This means that for every centimeter of height, the expected mouth opening is about 1.6 to 1.7 mm.
Deviations:
- Lower than Normal: May indicate restricted mouth opening (e.g., trismus, TMDs, fibrosis, ankylosis).
- Higher than Normal: May occur in conditions involving hypermobility.
Measured: after one month from the last laser session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start25 Dec 2024
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisordersStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nourhan M.Aly
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nourhan M.Aly, University of Alexandria
- Investigators
- Nermeen Rady, PhD, Principal investigator, Faculty of Dentistry, Alexandria University, EgyptMariam M Bahgat, PhD, Study chair, Faculty of Dentistry, Alexandria University, EgyptAly Atteya, PhD, Principal investigator, Faculty of Dentistry, Alexandria University, EgyptHoda MA Abdel-Naby, PhD, Study director, Faculty of Medicine, Alexandria University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06763419
- Sponsor's protocol ID
- 0828-12/2023
- Status last verified
- Jan 2025
- First submitted
- 23 Dec 2024
- Last updated
- 8 Jan 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 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internal Photobiomodulation For Management Of Temporomandibular Joint Internal Derangement: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06763419
- Acronym / sponsor ID
- 0828-12/2023
- Conditions
- Temporomandibular Joint Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nourhan M.AlyUniversity, hospital or other
- Study start
- 25 Dec 2024 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 8 Jan 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.
Aim of the study was to compare the efficacy of internal versus external photobiomodulation (PBM) in the management of patients with TMJ internal derangements (TMJ-ID).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| External low level laser therapy | Experimental | Device: External low level laser therapy |
| Internal low level laser therapy | Active comparator | Device: Internal low level laser therapy |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Painful click at temporomandibular joint (TMJ) area.
- Pain at the lateral pterygoid muscle.
- Presence of full or nearly full complement of natural teeth with acceptable occlusion
Key exclusion criteria (6 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 |
|---|---|---|
| External low level laser therapyPatients received 8 sessions of external diode laser (635 nm). | Device | External low level laser therapy |
| Internal low level laser therapyPatients received 8 diode laser (635 nm) sessions applied internally | Device | Internal low level laser therapy |
Primary outcome
Pain level assessment using Visual Analogue Scale
Time frame: after one month from the last laser session
All patients will be evaluated subjectively through Visual Analogue Scale (VAS) to clinically assess the pain intensity with ratings between 0 for pain-free and 10 for maximum pain
Oral health-related quality of life using OHIP-TMD
Time frame: after one month from the last laser session
Oral health-related quality of life will be assessed using OHIP-TMD, a 22-item temporomandibular disorder-specific version of the Oral Health Impact Profile (OHIP). Each item in the OHIP-TMDs is scored on a Likert scale, often ranging from: 0 (Never) to 4 (Very often). For each respondent, the scores for all 22 items are summed to create a total score. The total score ranges from 0 to 88, where higher scores indicate a greater negative impact on oral health-related quality of life.
Maximum mouth opening evaluation using the Miller index
Time frame: after one month from the last laser session
The Miller Index is calculated as a ratio of the observed maximum interincisal distance (distance between the edges of the upper and lower incisors when the mouth is fully open) to the patient's height. This provides a normalized measure of mouth opening relative to body stature. Miller Index= Maximum Interincisal Distance (mm)/Height (cm) Normal Range: A typical Miller Index is around 1.6 to 1.7 mm/cm in healthy individuals. This means that for every centimeter of height, the expected mouth opening is about 1.6 to 1.7 mm. Deviations: * Lower than Normal: May indicate restricted mouth opening (e.g., trismus, TMDs, fibrosis, ankylosis). * Higher than Normal: May occur in conditions involving hypermobility.
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 8 Jan 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.
Nermeen Rady, PhD principal investigator
Faculty of Dentistry, Alexandria University, Egypt
Mariam M Bahgat, PhD study chair
Faculty of Dentistry, Alexandria University, Egypt
Aly Atteya, PhD principal investigator
Faculty of Dentistry, Alexandria University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External low level laser therapy and Internal low level laser therapy in people with Temporomandibular Joint Disorders, run by Nourhan M.Aly 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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 8 Jan 2025. 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?
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 Mariam Bahgat, PhD (+20 12 22882107, mariam.amin@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level assessment using Visual Analogue Scale (time frame: after one month from the last laser session). 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 8 Jan 2025.