Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 12:04 AM
Study NCT ID:
NCT06140394
Status:
COMPLETED
Last Update Posted:
2024-06-28
First Post:
2023-11-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Low-Level Laser Therapy as an Adjunct to Non-surgical Therapy in Different Age Groups
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D054023', 'term': 'Lasers, Semiconductor'}], 'ancestors': [{'id': 'D007834', 'term': 'Lasers'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-27', 'studyFirstSubmitDate': '2023-11-12', 'studyFirstSubmitQcDate': '2023-11-16', 'lastUpdatePostDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical parameters (gingival index)', 'timeFrame': '6 months', 'description': 'measurement if the gingival index using scoring system. A score from 0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation from, and 2.1-3.0 signifies severe inflammation.'}, {'measure': 'clinical parameters (clinical attachment loss)', 'timeFrame': '6 months', 'description': 'measurement of clinical parameters clinical attachment loss in millimeters'}], 'secondaryOutcomes': [{'measure': 'assessment of inducible nitrous oxide synthase levels', 'timeFrame': '3 months', 'description': 'measurement of inducible nitrous oxide synthase levels in different age groups before the procedure and after using Elisa kit.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periodontal Inflammation']}, 'descriptionModule': {'briefSummary': 'the summary is to evaluate The Effect of Low-Level Laser Therapy as an Adjunct to Non-surgical Therapy on Inducible Nitrous Oxide Synthase Salivary Levels in Different Age Groups of Chronic Periodontitis Patients', 'detailedDescription': '2 ml of unstimulated saliva will be collected using spitting method, the collected samples will then be analyzed using Elisa technique for salivary Inducible nitrous oxide synthase levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* males and females\n* aged below 40 or above 60\n* periodontitis stage 2\n* no tooth loss due to periodontitis\n\nExclusion Criteria:\n\n* smoking habits\n* history of antibiotics\n* history of systemic diseases'}, 'identificationModule': {'nctId': 'NCT06140394', 'briefTitle': 'The Effect of Low-Level Laser Therapy as an Adjunct to Non-surgical Therapy in Different Age Groups', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Faculty of Dental Medicine for Girls'}, 'officialTitle': 'The Effect of Low-Level Laser Therapy as an Adjunct to Non-surgical Therapy on Inducible Nitrous Oxide Synthase Salivary Levels in Different Age Groups of Chronic Periodontitis Patients (A Randomized Clinical Trial)', 'orgStudyIdInfo': {'id': 'P-ME-23-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'old age group', 'description': 'old age group above 60 years old', 'interventionNames': ['Other: diode laser', 'Other: non surgical scaling']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'young aged group', 'description': 'young age group below 40 years old', 'interventionNames': ['Other: diode laser', 'Other: non surgical scaling']}], 'interventions': [{'name': 'diode laser', 'type': 'OTHER', 'description': 'low level diode therapy', 'armGroupLabels': ['old age group', 'young aged group']}, {'name': 'non surgical scaling', 'type': 'OTHER', 'description': 'non surgical scaling using ultrasonic', 'armGroupLabels': ['old age group', 'young aged group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11765', 'city': 'Cairo', 'state': 'Nasrcity Nasr Street', 'country': 'Egypt', 'facility': 'Al-Azhar University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'Hamdy Nassar', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': "Alaa H hesham mosa, bachelor's", 'role': 'STUDY_CHAIR', 'affiliation': 'Faculty of Dental Medicine for Girls'}, {'name': 'hamdy H nassar', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Dental Medicine for Girls'}, {'name': 'amal AA ali', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Dental Medicine for Girls'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Faculty of Dental Medicine for Girls', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Bachelor's Degree (research assistant)", 'investigatorFullName': 'Alaa Allah Hesham', 'investigatorAffiliation': 'Faculty of Dental Medicine for Girls'}}}}