Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2026-01-08 @ 4:22 AM
Study NCT ID:
NCT06819033
Status:
RECRUITING
Last Update Posted:
2025-03-25
First Post:
2025-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Photobiomodulation (PBM) on Pain After Presentation of Aphthous Ulcers in Pediatric Dental Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013281', 'term': 'Stomatitis, Aphthous'}], 'ancestors': [{'id': 'D013280', 'term': 'Stomatitis'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D028022', 'term': 'Low-Level Light Therapy'}, {'id': 'C013591', 'term': 'aluminum hydroxide, magnesium hydroxide, drug combination'}, {'id': 'D004155', 'term': 'Diphenhydramine'}], 'ancestors': [{'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010789', 'term': 'Phototherapy'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001559', 'term': 'Benzhydryl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-20', 'studyFirstSubmitDate': '2025-02-05', 'studyFirstSubmitQcDate': '2025-02-05', 'lastUpdatePostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Quality of life as assessed by questionnaire (Likert scale)', 'timeFrame': 'Baseline, immediately after treatment(about 5 minutes), 24 hours after treatment', 'description': 'This is a 6 item questionnaire and each is scored from 1-5, maximum score of 30,higher number indicating better outcome'}, {'measure': 'Pain as assessed by how frequently patient complains of pain (Likert scale)', 'timeFrame': 'upto 24 hours after treatment'}, {'measure': 'Pain as assessed by number of participants who are using any over-the-counter or prescription medications, topical treatments, or oral rinses to treat aphthous ulcer pain', 'timeFrame': 'upto 24 hours after treatment'}], 'secondaryOutcomes': [{'measure': 'Change in lesion size as an indication of healing as assessed by clinical intraoral images of the aphthous ulcer and measuring tool', 'timeFrame': 'pre-treatment and immediately post-treatment(about 5 minutes)'}, {'measure': 'Change in pain as assessed by a Visual Analogue Scale (VAS) for control group', 'timeFrame': 'Baseline, 24 hours after treatment', 'description': 'Pain level is scored from 0(no pain) to 10(worst pain)'}, {'measure': 'Pain as assessed by a Visual Analogue Scale (VAS) for experimental group', 'timeFrame': 'Baseline, immediately after PBM(about 5 minutes), 24 hours after treatment', 'description': 'Pain level is scored from 0(no pain) to 10(worst pain)'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['magic mouthwash', 'laser treatment'], 'conditions': ['Aphthous Ulcer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy of laser photobiomodulation and "Magic Mouthwash" for treatment of pain in pediatric patients with aphthous ulcers , to assess how photobiomodulation influences the rate of healing of aphthous ulcers in pediatric patients and to measure changes in pain levels reported by pediatric patients undergoing photobiomodulation treatment for aphthous ulcers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient/guardian speaks either English or Spanish\n* Patient presenting with one or more aphthous ulcers in their mouth, identified during a scheduled dental appointment\n* No previous PBM treatment to the presenting aphthous ulcer(s)\n* Guardian able to partake in a follow-up phone call in either the English or Spanish language\n\nExclusion Criteria:\n\n* Patient presents with aphthous ulcers recently treated with PBM\n* Patient presents with herpes labialis (cold sores)\n* Patients presents with systemic disease that affects soft tissue/mucous healing'}, 'identificationModule': {'nctId': 'NCT06819033', 'briefTitle': 'Effects of Photobiomodulation (PBM) on Pain After Presentation of Aphthous Ulcers in Pediatric Dental Patients', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Effects of Photobiomodulation on Pain After Presentation of Aphthous Ulcers in Pediatric Dental Patients', 'orgStudyIdInfo': {'id': 'HSC-DB-24-1153'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PBM Therapy', 'interventionNames': ['Device: PBM Therapy', 'Drug: Maalox plus Benadryl']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of care', 'interventionNames': ['Drug: Maalox plus Benadryl']}], 'interventions': [{'name': 'PBM Therapy', 'type': 'DEVICE', 'description': 'patients will receive PBM therapy using the Biolase Epic pro laser. An average power of 0.6w (peak power = 80w, rep. rate= 20Hz). Each aphthous ulcer will be irradiated one time for a total of 30 seconds via continuous wave.', 'armGroupLabels': ['PBM Therapy']}, {'name': 'Maalox plus Benadryl', 'type': 'DRUG', 'description': '1:1 mixture of Maalox and Benadryl will be applied to the ulcer as needed for pain. Applications typically will be applied before eating to form a dissolvable oral band-aid that lasts for up to 30 minutes. 10 milliliters of 1:1 Maalox: Benadryl solution will be provided to the family. During the presenting appointment, the patient/family will be shown how to use the 1:1 Maalox: Benadryl solution. It will be applied topically with no rinsing needed.', 'armGroupLabels': ['PBM Therapy', 'Standard of care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brett Chiquet, DDS, PhD', 'role': 'CONTACT', 'email': 'Brett.T.Chiquet@uth.tmc.edu', 'phone': '713-500-8220'}, {'name': 'Jessica Hochschuler', 'role': 'CONTACT', 'email': 'Jessica.L.Hochschuler@uth.tmc.edu', 'phone': '(713) 486-4141'}], 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Brett Chiquet, DDS, PhD', 'role': 'CONTACT', 'email': 'Brett.T.Chiquet@uth.tmc.edu', 'phone': '(713) 500-8220'}, {'name': 'Jessica Hochschuler', 'role': 'CONTACT', 'email': 'Jessica.L.Hochschuler@uth.tmc.edu', 'phone': '(713) 486-4141'}], 'overallOfficials': [{'name': 'Brett Chiquet, DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Brett Thomas Chiquet', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}