Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 1:57 AM
Study NCT ID:
NCT07403695
Status:
COMPLETED
Last Update Posted:
2026-02-12
First Post:
2026-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Photobiomodulation Therapy on Nerve Repair Using Red and Infra-red Diode Lasers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-01-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-10', 'studyFirstSubmitDate': '2026-02-05', 'studyFirstSubmitQcDate': '2026-02-05', 'lastUpdatePostDateStruct': {'date': '2026-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual analogue scale', 'timeFrame': '1,2,4,8,12 weeks', 'description': 'from 1- 10\n\n1 means no pain 10 means worst pain'}], 'secondaryOutcomes': [{'measure': 'clinical neurosensory test', 'timeFrame': '2,4,8,12 weeks', 'description': 'from S0 to S4 S0 means worst neurosensory function S4 full recovery for neurosensory function'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['laser therapy', 'photobiomodulation', 'nerve injury'], 'conditions': ['Nerve Injury']}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient aged range from 20-50 years old\n2. Patient suffering from nerve injury in the maxillofacial region for a period of 6 months or more without improvement.\n\nExclusion Criteria:\n\n* 1- Patient had undergone micro-neurosurgery to correct neurosensory deficit.'}, 'identificationModule': {'nctId': 'NCT07403695', 'briefTitle': 'Photobiomodulation Therapy on Nerve Repair Using Red and Infra-red Diode Lasers', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Comparison Between Photobiomodulation Therapy on Nerve Repair Using Red and Infra-red Diode Lasers in Maxillofacial Region (A Randomized Clinical Trial)', 'orgStudyIdInfo': {'id': '00010556- 0008839'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '635 wavelength', 'interventionNames': ['Device: 635 wavelength']}, {'type': 'ACTIVE_COMPARATOR', 'label': '980 wavelength', 'interventionNames': ['Device: 980 wavelength']}], 'interventions': [{'name': '635 wavelength', 'type': 'DEVICE', 'description': '635 wavelength laser', 'armGroupLabels': ['635 wavelength']}, {'name': '980 wavelength', 'type': 'DEVICE', 'description': '980 wavelength laser', 'armGroupLabels': ['980 wavelength']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Alexandria university', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Mona S Oraby', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alexandria University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'mona oraby', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'mona oraby', 'investigatorAffiliation': 'Alexandria University'}}}}