Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2025-12-30 @ 3:19 PM
Study NCT ID:
NCT07033403
Status:
COMPLETED
Last Update Posted:
2025-12-02
First Post:
2025-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Low-Level Laser Therapy on Wound Healing and Post-extraction Pain Management of Primary Molars.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D028022', 'term': 'Low-Level Light Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}], 'ancestors': [{'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-29', 'studyFirstSubmitDate': '2025-06-03', 'studyFirstSubmitQcDate': '2025-06-13', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'wound healing', 'timeFrame': 'days 3 and 7', 'description': 'wound healing will be measured using using the Landry, Turnbull and Howley wound healing index , with minimum score 1 and maximum score 5 , as the score inceases this means better healing.'}, {'measure': 'post-extraction pain (PEP)', 'timeFrame': 'days 3 and 7', 'description': 'post- extraction pain will be measured using the Arabic Version of a self-reported Questionnaire Assessing Pain, Discomfort and Related Jaw Function Impairment in Children on the night of extraction and on day 7 using WONG-BAKER FACES pain scale with 0 minimum and 10 maximum value. the higher the value the worse the outcome.'}, {'measure': 'wound size measurements', 'timeFrame': 'days 3 and 7', 'description': 'wound size measurments immediately after the extraction, and at days 3 and using Image J software'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['wound healing', 'photobiomodulation', 'post-extraction pain (PEP)'], 'conditions': ['Post-extraction Pain (PEP)', 'Wound Healing']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the effect of low-level laser therapy on wound healing of primary molar teeth extraction. in children aged 5-8 years with bilateral primary molars indicated for extraction. The main questions it aims to answer are:\n\n* does low-level laser therapy affect wound healing of primary molar teeth extraction?\n* does of low-level laser therapy affect post-extraction pain management of primary molar.? Researchers will compare placebo group (Sham side) to Intervention side ( split mouth design).\n\nParticipants will be subjected to low level laser and post-extraction instructions in the intervention side, while the placebo side will receive post-extraction instructions only, participants will come for follow up on days 3, and 7 after extraction, they will answer self-reported questionnare related to post-extraction pain , wound healing will also be measured from photographs of the extraction site using Image J soft-ware', 'detailedDescription': 'The goal of this clinical trial is to evaluate the effect of low-level laser therapy on wound healing of primary molar teeth extraction. in children aged 5-8 years with bilateral primary molars indicated for extraction. this is a split mouth randomized controlled clinical trial.\n\nEach participant will have one side randomly assigned to intervention using low level diode laser at a wavelength of 660nm aimed at the extraction site 1 cm away for 60 seconds in continuous emission mode. the other side will be placebo side with just the aiming beam, in both visits the participant will be given post-extraction instructions\n\nparticipants will come for follow up on days 3, and 7 after extraction, they will answer an arabic self-reported questionnaire comprising 33 items that assessed pain, discomfort, analgesic consumption, daily activities, and jaw-function impairment on the night of the extraction and after 7 days, wound healing will also be measured days 3 and 7 using of the extraction site using Wound healing index by Landry, Turnbull and Howley, and wound size will be measured using Image J soft-ware from the from photographs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Age range from 5 - 8 years.\n\n * Children free of any systemic disease or special health care need.\n * No previous extractions.\n * Positive or definitely positive behaviour during preoperative assessments according to the Frankl Rating Scale (score 3 or 4).\n * Patients with bilateral primary molars indicated for extraction.\n * Patients whose parents will give their written consent to participate\n\nExclusion Criteria:\n\n* Resorption more than one third of the root length.\n* Signs of mobility.\n* History of allergy to local anesthesia.\n* Medical History involving conditions such as prolonged bleeding, platelet disorders, hypersensitivity, allergic reactions to pain relievers and contradictions to laser therapy.\n* Acute pain.'}, 'identificationModule': {'nctId': 'NCT07033403', 'briefTitle': 'Effect of Low-Level Laser Therapy on Wound Healing and Post-extraction Pain Management of Primary Molars.', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Effect of Low-Level Laser Therapy on Wound Healing and Post-extraction Pain Management of Primary Molars. (a Randomized Controlled Clinical Trial)', 'orgStudyIdInfo': {'id': '1002-11/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention', 'description': 'intervention arm using low-level laser therapy photobiomodulation', 'interventionNames': ['Device: Low Level Laser Therapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo (Sham)', 'description': 'sham (placebo) arm', 'interventionNames': ['Behavioral: Placebo plus Treatment As Usual']}], 'interventions': [{'name': 'Low Level Laser Therapy', 'type': 'DEVICE', 'description': 'low-level laser therapy (LLLT) at a wavelength of 660nm (SiroLaser Blue, Dentsply Sirona, USA) after extraction', 'armGroupLabels': ['intervention']}, {'name': 'Placebo plus Treatment As Usual', 'type': 'BEHAVIORAL', 'description': 'placebo (Sham) with only the aiming beam of thelow-level laser therapy (LLLT)', 'armGroupLabels': ['placebo (Sham)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5310002', 'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Faculty of Dentistry-Alexandria University', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}