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Not yet recruitingNCT07590414Updated May 15, 2026

High-intensity Laser Therapy Versus Low Level Laser Therapy in the Treatment of Trigeminal Neuralgia

An interventional study of 1064 nm Nd-YAG Laser and 940 nm Diode laser in Trigeminal Neuralgia, sponsored by Alexandria University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-15.

Sponsored by Alexandria University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Trigeminal neuralgia (TN) is the most common and severe type of neuropathic pain disorder affecting the orofacial region. It is characterized by sudden, intense, episodic attacks of pain in the distribution of trigeminal nerve, usually unilateral. The condition severely impairs patient's quality of life. TN represents a diagnostic and therapeutic challenge, pharmacological therapy remains the first-line management, and many patients experience reduced drug tolerance or significant side effects over time. Surgical options are considered for refractory cases but are invasive and carry risks such as infection, nerve damage, and recurrence of symptoms. In recent years, laser based therapies have gained attention as safe, non-invasive alternatives. Low level laser therapy (LLLT) promotes photo-biomodulation and nerve repair without thermal damage, while high-intensity laser therapy (HILT) can achieve deeper penetration and direct neuromodulation. However, comparative evidence regarding their efficacy in TN is still limited. Aim: The present study aims to evaluate and compare the effect of High intensity laser therapy and low level laser therapy in reducing pain intensity and improving quality of life in patients with trigeminal neuralgia.

02

Conditions studied

  • Trigeminal Neuralgia

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03

In context

Trigeminal Neuralgia

140 studies on the registry are indexed under Trigeminal Neuralgia; 44 are open to participants now.

This study's planned enrollment of 38 is close to the median of 40 across 93 interventional studies indexed under Trigeminal Neuralgia.

Browse Trigeminal Neuralgia studies →

Lead sponsor

Alexandria University is the lead sponsor of 606 studies on the registry; 141 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients diagnosed with trigeminal neuralgia according to the International Classification of Headache Disorders (ICHD-3) diagnostic criteria.
  • Patients with drug trigeminal neuralgia (defined as poor response to adequate pharmacological treatment or intolerance to side effects for at least three months).
  • Patients who are for surgical intervention or any other interventions, or who have previously undergone such interventions without obtaining satisfactory pain relief.

Exclusion criteria

Exclusion Criteria:

  • patients with secondary trigeminal neuralgia diagnosed with brain lesions that is indicated for surgery (percutaneous procedures, gamma knife, microvascular decompression).
  • Patients with other orofacial conditions such as temporomandibular disorders, migraine, or other neurological diseases.
  • Patients with to laser use (e.g., pacemakers).
  • Patients who are responding well to medical treatment.
  • Pregnant or lactating women.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
38 participants (estimated)

Study arms

  • Experimental
    Nd-YAG Laser

    Other: 1064 nm Nd-YAG Laser

  • Experimental
    Diode laser

    Other: 940 nm Diode laser

Interventions

  • Other1064 nm Nd-YAG Laser

    This group will receive twelve sessions of High-intensity laser therapy (HILT) using using 1064nm Nd:YAG laser in Piano mode using a Fotona LightWalker® , with three session per week

  • Other940 nm Diode laser

    This group will recive twelve sessions of Low Level Laser Therapy (LLLT) using (940 nm Diode laser epicX manfactured by Biolase. The deep tissue handpice (30 mm diameter) will be used, with three session per week

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What researchers measure

Primary outcomes

  1. Change in pain scores

    Subjective Pain score as measured by Numerical Rating Scale (NRS) \[26\] . Pain will be measured at baseline and at weeks 1, 2, 3, 4, 8, and 12

    Time frame: up to 12 weeks

  2. Change in quality of life

    it will be assessed using OHIP-14 questionnaire at baseline, and 4, 8, 12 weeks.

    Time frame: up to 12 weeks

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Study locations

1 site
  • Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt
    Alexandria, Egypt
    • Faculty of Dentistry · Contact(203) 4868308
    • Ekhlas Abdalrahman, BDS · Principal investigator
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for May 2026; primary completion for Dec 2026, 7 months later.

Of 33 non-industry interventional studies with no phase under Trigeminal Neuralgia, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 40. This study's planned 7 months is below that.

Counting every sponsor, half of 33 studies reached it within 27 months; a quarter within 11 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered
May 10, 2026
First posted
May 15, 2026
StartEst.
May 15, 2026
Primary completionEst.
Dec 30, 2026
CompletionEst.
Dec 30, 2026
Last update
May 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07590414
Responsible party
Sponsor
First posted
May 15, 2026
Start date
May 15, 2026 (estimated)
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
May 15, 2026

Study contacts

Ekhlas Abdalrahman, BDS
Contact
ekhlas.babiker44@gmail.com
00249110934300

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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