Ignite Creation Date:
2025-12-24 @ 5:22 PM
Ignite Modification Date:
2025-12-28 @ 8:22 PM
Study NCT ID:
NCT05820750
Status:
UNKNOWN
Last Update Posted:
2023-04-20
First Post:
2023-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical and Radiographic Evaluation of Photodynamic Therapy for Root Canal Treatment of Primary Molars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010778', 'term': 'Photochemotherapy'}, {'id': 'D011670', 'term': 'Pulpectomy'}, {'id': 'C498115', 'term': 'Metapex'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D010789', 'term': 'Phototherapy'}, {'id': 'D004708', 'term': 'Endodontics'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-06', 'studyFirstSubmitDate': '2023-03-27', 'studyFirstSubmitQcDate': '2023-04-06', 'lastUpdatePostDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of clinical success of photodynamic therapy', 'timeFrame': '14 months', 'description': 'The following criteria will be used for the determination of treatment success or failure:\n\n1. Repair (= success) Clinically: absence of signs and symptoms.\n2. Lack of repair (= failure) Clinically: signs and symptoms indicative of acute apical periodontitis.'}, {'measure': 'Evaluation of radiographic success of photodynamic therapy', 'timeFrame': '14 months', 'description': 'The following criteria will be used for the determination of treatment success or failure:\n\n1. Complete repair (= success) Radiographically: absence of pathological root resorption, normal width of periodontal ligament space, absence of lesion development in periapical regions in cases of absence of lesion in the initial diagnostic radiograph and complete regression of lesion in cases of presence of lesion in the initial diagnostic radiograph.\n2. Incomplete repair (= success) Radiographically: absence of pathological root resorption and reduction lesion size in the periapical region.\n3. Lack of repair (= failure) Radiographically: presence of pathological root resorption, lesion in furcation/periapical region unchanged in size during follow-up period, increase in lesion size or the development of a new lesion.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Photodynamic Therapy']}, 'descriptionModule': {'briefSummary': 'This study will be conducted to evaluate clinical and radiographic success of Photodynamic Therapy for root canal treatment of primary molars in comparison to the standard root canal treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 4-7 years.\n* Apparent healthy child not suffering from any mental or physical disability.\n* Cooperative children.\n* Restorable teeth.\n* Each child should have at least one carious primary molar with signs and symptoms of irreversible pulpitis or pulp necrosis.\n* Absence of internal and / or external perforation in the furcation area.\n* At least 2/3 thirds of the roots should be remained.\n\nExclusion Criteria:\n\n* Children with compromised health or physical disability.\n* Resorption of the roots more than 2/3 thirds.\n* Non restorable teeth.'}, 'identificationModule': {'nctId': 'NCT05820750', 'briefTitle': 'Clinical and Radiographic Evaluation of Photodynamic Therapy for Root Canal Treatment of Primary Molars', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Clinical and Radiographic Evaluation of Photodynamic Therapy for Root Canal Treatment of Primary Molars', 'orgStudyIdInfo': {'id': 'M02041022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'standard root canal treatment', 'interventionNames': ['Procedure: pulpectomy with metapex']}, {'type': 'OTHER', 'label': 'photodynamic therapy', 'interventionNames': ['Device: photodynamic therapy']}, {'type': 'OTHER', 'label': 'instrumentation and photodynamic therapy', 'interventionNames': ['Device: photodynamic therapy']}], 'interventions': [{'name': 'photodynamic therapy', 'type': 'DEVICE', 'description': 'root canal treatment of primary molars using photodynamic therapy', 'armGroupLabels': ['instrumentation and photodynamic therapy', 'photodynamic therapy']}, {'name': 'pulpectomy with metapex', 'type': 'PROCEDURE', 'description': 'root canal treatment using standard technique', 'armGroupLabels': ['standard root canal treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35511', 'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Mohamed El Sayed Abo Farrag', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer at paediatric dentistry department', 'investigatorFullName': 'Mohamed Elsayed Abo Farrag', 'investigatorAffiliation': 'Mansoura University'}}}}