Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 1:13 AM
Study NCT ID:
NCT07436650
Status:
RECRUITING
Last Update Posted:
2026-03-19
First Post:
2026-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of High-Level Laser Therapy in Managing Oral Mucositis Among Pediatric Patients Undergoing Hematopoietic Stem Cell Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013280', 'term': 'Stomatitis'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D028022', 'term': 'Low-Level Light Therapy'}], 'ancestors': [{'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2026-02-22', 'studyFirstSubmitQcDate': '2026-02-22', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oral mucositis score', 'timeFrame': 'at baseline (day 1), day 7, and day 11 from the start of treatment', 'description': 'World Health Organization (WHO) scale of oral mucositis will be used to describe the lesions at baseline, day 7 and day 11, lesions are given grades from 1 to 4, with 4 being a worse outcome'}], 'secondaryOutcomes': [{'measure': 'Pain score', 'timeFrame': 'at baseline (day 1), day 7, and day 11 from the start of treatment', 'description': 'Pain visual analogue scale will be used to measure pain level, where the patient will be given a diagram representing pain levels from 1 to 10, 10 being the highest level of pain'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oral Mucositis', 'High Level Laser Therapy', 'Hematopoietic Stem cell Transplant'], 'conditions': ['Oral Mucositis']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if high-level laser therapy can manage oral mucositis in pediatric patients undergoing hematopoietic bone marrow transplantation. The main question it aims to answer is :\n\nIs high-level laser therapy effective as a treatment for oral mucositis in pediatric hemopoietic stem cell transplant patients? Researchers will compare patients receiving basic oral care to see the effect on the WHO oral mucositis scale.\n\nParticipants will be subjected to high level laser on lesion sites .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children under the age of 18 years undergoing bone marrow transplantation during the phase of oral mucositis.\n* Oral mucositis starting from grade II on the WHO scale for OM.\n* Willingness to undergo treatment for four consecutive days and to return for evaluation 7 and 11 days after enrolment.\n\nExclusion Criteria:\n\n* Previous treatment with photobiomodulation for oral mucositis.\n* Limited mouth opening less than 2 cm.\n* Presence of dysplastic oral lesions.\n* Radiotherapy in the head and neck area.\n* Vulnerable groups of patients or decision-impaired individuals as prisoners, handicapped and mentally retarded individuals'}, 'identificationModule': {'nctId': 'NCT07436650', 'briefTitle': 'Efficacy of High-Level Laser Therapy in Managing Oral Mucositis Among Pediatric Patients Undergoing Hematopoietic Stem Cell Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Efficacy of High-Level Laser Therapy in Managing Oral Mucositis Among Pediatric Patients Undergoing Hematopoietic Stem Cell Transplantation: A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'FDASU-Rec IR/D052511'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High power laser therapy group', 'description': 'Pediatric bone marrow transplantation patients with oral mucositis will receive high-power laser therapy once daily for four consecutive days. The laser parameters will be a wavelength of 660 to 970 nm, of power 3.2 w, pulsed at 50% duty cycle, spot size of 1 cm2, for 230 sec, defocused mode.', 'interventionNames': ['Device: high power laser therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Basic oral care group', 'description': 'Pediatric bone marrow transplantation patients with oral mucositis will receive standard basic oral care. Local methods: mouth rinse chlorohexidine three times a day, sodium bicarbonate mouthwash.', 'interventionNames': ['Drug: Basic oral care']}], 'interventions': [{'name': 'high power laser therapy', 'type': 'DEVICE', 'otherNames': ['Laser biostimulation', 'Photobiomodulation therapy'], 'description': 'high power laser therapy once daily for four consecutive days with wavelength 660 to 970 nm, power 3.2 w, and duration of 230 seconds at 50% duty cycle', 'armGroupLabels': ['High power laser therapy group']}, {'name': 'Basic oral care', 'type': 'DRUG', 'otherNames': ['conventional therapy'], 'description': 'patients will receive local methods: cholorohexidine mouthwash as well sodium bicarbonate mouthwash', 'armGroupLabels': ['Basic oral care group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '+2', 'city': 'Cairo', 'state': 'Cairo Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': "Oncology and Bone marrow transplant unit, Children's hospital, Ain Shams University", 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Asmaa Ayman Gabr, Teaching Assistant', 'role': 'CONTACT', 'email': 'Asmaagabr@dent.asu.edu.eg', 'phone': '+2 01095692889'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Teaching Assistant', 'investigatorFullName': 'Asmaa Ayman Mohammed Gabr', 'investigatorAffiliation': 'Ain Shams University'}}}}