- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07403695
Photobiomodulation Therapy on Nerve Repair Using Red and Infra-red Diode Lasers
Comparison Between Photobiomodulation Therapy on Nerve Repair Using Red and Infra-red Diode Lasers in Maxillofacial Region (A Randomized Clinical Trial)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Alexandria, Egypt
- Alexandria University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 1- Patient had undergone micro-neurosurgery to correct neurosensory deficit.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 635 wavelength
|
635 wavelength laser
|
|
Active Comparator: 980 wavelength
|
980 wavelength laser
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
visual analogue scale
Time Frame: 1,2,4,8,12 weeks
|
from 1- 10 1 means no pain 10 means worst pain |
1,2,4,8,12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
clinical neurosensory test
Time Frame: 2,4,8,12 weeks
|
from S0 to S4 S0 means worst neurosensory function S4 full recovery for neurosensory function
|
2,4,8,12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mona S Oraby, Alexandria University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 00010556- 0008839
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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