Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-02-25 @ 8:59 PM
Study NCT ID:
NCT02479958
Status:
COMPLETED
Last Update Posted:
2015-06-25
First Post:
2015-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An in Vitro Evaluation of Antimicrobial Photodynamic Therapy on Deciduous Carious Dentin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-24', 'studyFirstSubmitDate': '2015-05-25', 'studyFirstSubmitQcDate': '2015-06-20', 'lastUpdatePostDateStruct': {'date': '2015-06-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantification of Bacteria by quantitative Polymerase Chain Reaction (PCR)', 'timeFrame': '15 days after dentin collection', 'description': 'Quantification of S. mutans, L. casei, F. nucleatum, A. rimae and total bacteria by PCR (Polymerase Chain Reaction)'}], 'secondaryOutcomes': [{'measure': 'Tooth Pain', 'timeFrame': '6 months', 'description': 'Patients reported the presence or absence of tooth pain after 6 months'}, {'measure': 'Tooth Pain', 'timeFrame': '12 months', 'description': 'Patients reported the presence or absence of tooth pain after 6 months'}, {'measure': 'Restoration Quality', 'timeFrame': '6 months', 'description': 'The quality of restoration was evaluated through the absence of radiographic radiolucent area after 6 months'}, {'measure': 'Restoration Quality', 'timeFrame': '12 months', 'description': 'The quality of restoration was evaluated through the absence of radiographic radiolucent area after 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Photochemotherapy', 'Bacteria'], 'conditions': ['Dental Caries']}, 'descriptionModule': {'briefSummary': 'Despite of the decline of dental caries, this disease is still common in polarized groups affecting children. Therefore, the aim of this randomized blind in vivo study was to compare the antimicrobial effect of two antimicrobial therapies in deciduous carious dentin. Thirty two patients aging from 5 to 7 years old had partial caries removal in deep carious dentin lesion in deciduous molar and were divided in three groups: 1. Control - chlorhexidine and resin modified glass ionomer cement (RMGIC); 2. LEDTB - antimicrobial photodynamic therapy (APDT) with LED (light emission diode) associated with toluidine blue orto dye solution and RMGIC; 3. LMB - APDT with laser associated with methylene blue dye solution and RMGIC. The patients were submitted to initial clinical and radiographic examination and demographic features were evaluated by biofilm, gingival, and dmft/dmfs indexes, besides clinical and radiographic follow up at 6 and 12 months after the treatments. The carious dentin was collected before and after each treatment and the number of Streptococcus mutans, Streptococcus sobrinus, Lactobacillus casei, Fusobacterium nucleatum, Atopobium rimae and total bacteria were established by quantitative PCR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion criteria consisted of good general health, without syndromes or chronic systemic diseases. They should also have at least one primary molar with deep carious lesion (2/3 of dentin) without pain symptomatology and compatible with reversible pulpits.\n\nExclusion Criteria:\n\n* Children whose parents refused to sign the informed consent document, who did not cooperate with the clinical exams, whose teeth had the treatment choice changed (pain or evolution to irreversible pulpits), who did not attend to the appointments for the scheduled treatments, or who needed antibiotics treatment for other medical reasons were excluded from the study without prejudice.'}, 'identificationModule': {'nctId': 'NCT02479958', 'briefTitle': 'An in Vitro Evaluation of Antimicrobial Photodynamic Therapy on Deciduous Carious Dentin', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'A Randomized in Vitro Evaluation of Antimicrobial Photodynamic Therapy on Deciduous Carious Dentin', 'orgStudyIdInfo': {'id': '150/10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control', 'interventionNames': ['Procedure: Rubber dam isolation', 'Procedure: Tooth drying', 'Procedure: Dentin wash with chlorhexidine 2%']}, {'type': 'EXPERIMENTAL', 'label': 'APDT 1', 'interventionNames': ['Procedure: Rubber dam isolation', 'Procedure: Tooth drying', 'Procedure: Antimicrobial Photodynamic Therapy 1']}, {'type': 'EXPERIMENTAL', 'label': 'APDT 2', 'interventionNames': ['Procedure: Rubber dam isolation', 'Procedure: Tooth drying', 'Procedure: Antimicrobial Photodynamic Therapy 2']}], 'interventions': [{'name': 'Rubber dam isolation', 'type': 'PROCEDURE', 'description': 'Tooth was isolated using a rubber dam isolation in order to collect the dentin samples', 'armGroupLabels': ['APDT 1', 'APDT 2', 'Control']}, {'name': 'Tooth drying', 'type': 'PROCEDURE', 'description': 'The tooth was dried with air jet.', 'armGroupLabels': ['APDT 1', 'APDT 2', 'Control']}, {'name': 'Dentin wash with chlorhexidine 2%', 'type': 'PROCEDURE', 'description': 'Partial carious tissue was removed with conventional dentinal curette and collection of dentin with a micropunch (Ø = 1mm) was performed. The remaining dentin was washed with chlorhexidine 2%. After that a a new dentin collection was performed at another site of the cavity, and restoration with resin-modified glass ionomer cement was placed.', 'armGroupLabels': ['Control']}, {'name': 'Antimicrobial Photodynamic Therapy 1', 'type': 'PROCEDURE', 'description': 'Partial carious tissue was removed with conventional dentine curette and collection of dentin with a micropunch (Ø = 1mm) was performed. The remaining dentin was washed with 200 µL of O-Toluidine blue dye (0.1 mg/mL) for 60 s. After this, a red LED light source with wavelength of 630 nm was used at 100 mW power, 9.0 J of energy, for 60 s with energy density of 30.0 J/cm2 . A new dentin collection was performed after this treatment at another site of the cavity and restoration with resin-modified glass ionomer cement Vitremer was placed.', 'armGroupLabels': ['APDT 1']}, {'name': 'Antimicrobial Photodynamic Therapy 2', 'type': 'PROCEDURE', 'description': 'Partial carious tissue was removed with conventional dentine curette and initial collection of dentin with a micropunch (Ø = 1mm) was performed. Treatment of the remaining dentin was performed with 200 µL of methylene blue dye 0.01% for 5 min and after this, a red low level LASER light source with wavelength of 660 nm was used at 100 mW power, 9.0 J of energy, for 90 s with energy density of 320.0 J/cm2 . A new dentin collection was performed after this treatment at another site of the cavity and restoration with resin-modified glass ionomer cement was placed.', 'armGroupLabels': ['APDT 2']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Carolina Steiner-Oliveira', 'investigatorAffiliation': 'University of Sao Paulo'}}}}