NCT07403695

Brief Summary

Peripheral nerve injury is a major concern that drastically affects the patient's quality of life. Nowadays, several treatment options are available, including medical treatments, surgical intervention, and others. However, the trending photobiomodulation effect of laser therapy is attracting many dental professionals due to its promising results on nerve rehabilitation. The study is intended to assess and compare laser photobiomodulation using red and infra-red diode lasers on the repair of nerve injury in the maxillofacial region.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 18, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2026

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

10 months

First QC Date

February 5, 2026

Last Update Submit

February 10, 2026

Conditions

Nerve Injury

Keywords

laser therapyphotobiomodulationnerve injury

Outcome Measures

Primary Outcomes (1)

  • visual analogue scale

    from 1- 10 1 means no pain 10 means worst pain

    1,2,4,8,12 weeks

Secondary Outcomes (1)

  • clinical neurosensory test

    2,4,8,12 weeks

Study Arms (2)

635 wavelength

EXPERIMENTAL
Device: 635 wavelength

980 wavelength

ACTIVE COMPARATOR
Device: 980 wavelength

Interventions

635 wavelengthDEVICE

635 wavelength laser

635 wavelength
980 wavelengthDEVICE

980 wavelength laser

980 wavelength

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patient aged range from 20-50 years old
  • Patient suffering from nerve injury in the maxillofacial region for a period of 6 months or more without improvement.

You may not qualify if:

  • Patient had undergone micro-neurosurgery to correct neurosensory deficit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria university

Alexandria, Egypt

Location

Study Officials

  • Mona S Oraby

    Alexandria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

February 5, 2026

First Posted

February 11, 2026

Study Start

March 18, 2025

Primary Completion

January 18, 2026

Study Completion

January 18, 2026

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)