Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-26 @ 1:34 AM
Study NCT ID:
NCT05100433
Status:
COMPLETED
Last Update Posted:
2023-11-29
First Post:
2021-09-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Passive Ultrasonic Irrigation on Bacteria That Persist After Root Canal Preparation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001424', 'term': 'Bacterial Infections'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-11-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-28', 'studyFirstSubmitDate': '2021-09-20', 'studyFirstSubmitQcDate': '2021-10-18', 'lastUpdatePostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bacterial Activity', 'timeFrame': 'through study completion, an average of 3 years', 'description': 'The metabolic activity of total bacteria in root canal samples after ultrasonic irrigation'}], 'secondaryOutcomes': [{'measure': 'Bacterial Levels', 'timeFrame': 'through study completion, an average of 3 years', 'description': 'Quantitative data of total bacteria determined by quantitative polymerase chain reaction after endodontic procedures'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bacterial Infections']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effectiveness of ultrasonic irrigation in improving root canal disinfection after chemomechanical procedures.', 'detailedDescription': 'Although chemomechanical procedures promote a drastic bacterial reduction, many root canals remain infected, which points to the need for complementary procedures to improve root canal disinfection. Thus, this clinical study aims to evaluate the effect of passive ultrasonic irrigation as a supplementary disinfection procedure after root canal preparation. Microbiological samples of the root canals of 30 single-rooted teeth with apical periodontitis will be taken at different stages of the endodontic treatment: before preparation (S1), after chemomechanical procedures (S2) and after passive ultrasonic irrigation (S3). The samples will be submitted to the quantitative polymerase chain reaction for bacterial quantification and to the reverse transcription quantitative polymerase chain reaction for bacterial activity analysis. Data will be analyzed using the Wilcoxon test for paired samples (p \\< 0.05).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Teeth with necrotic pulps and asymptomatic apical periodontitis\n\nExclusion Criteria:\n\n* patients who had received antibiotics during the previous 3 months or had any general disease,\n* teeth that could not be properly isolated with rubber dam,\n* non-restored teeth,\n* periodontal pockets depths greater than 4 mm,\n* previous endodontic treatment,\n* open apex,\n* crown/root fracture\n* root resorption or calcifications.'}, 'identificationModule': {'nctId': 'NCT05100433', 'briefTitle': 'Effect of Passive Ultrasonic Irrigation on Bacteria That Persist After Root Canal Preparation', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Effect of Passive Ultrasonic Irrigation on Bacteria That Persist After Root Canal Preparation in Teeth With Apical Periodontitis', 'orgStudyIdInfo': {'id': 'FAPESP 2016/15473-0-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Microbiological analysis of root canals after endodontic procedures', 'description': 'Bacterial levels and activity in root canal samples after chemomechanical procedures and ultrasonic irrigation.', 'interventionNames': ['Procedure: Ultrasonic irrigation']}], 'interventions': [{'name': 'Ultrasonic irrigation', 'type': 'PROCEDURE', 'description': 'Ultrasonic irrigation will be used as a complementary step to chemomechanical procedures to test whether it can improve root canal disinfection.', 'armGroupLabels': ['Microbiological analysis of root canals after endodontic procedures']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05508000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'University of São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ericka Tavares Pinheiro', 'investigatorAffiliation': 'University of Sao Paulo'}}}}