Not Yet Recruiting

NCT Number: NCT07590414

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Trigeminal Neuralgia Cranial Nerve Diseases Facial Nerve Diseases Facial Neuralgia Mouth Diseases Nervous System Diseases Stomatognathic Diseases Trigeminal Nerve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Egypt

Location contact

Ekhlas Abdalrahman, BDS

PRINCIPAL_INVESTIGATOR

Faculty of Dentistry

CONTACT

(203) 4868308

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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 contraindications to laser use (e.g., pacemakers).
Patients who are responding well to medical treatment.
Pregnant or lactating women.

Treatment and study plan

1064 nm Nd-YAG Laser

Other

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

940 nm Diode laser

Other

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

Primary outcomes

Change in pain scores

Time frame: up to 12 weeks

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
Change in quality of life

Time frame: up to 12 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ekhlas Abdalrahman, BDS

CONTACT

[email protected]

00249110934300

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

High-intensity Laser Therapy Versus Low Level Laser Therapy in the Treatment of Trigeminal Neuralgia (a Randomized Clinical Trial)

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: May 15, 2026
Registry last updated: May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting