Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-02-25 @ 6:35 PM
Study NCT ID:
NCT04637659
Status:
COMPLETED
Last Update Posted:
2020-11-20
First Post:
2020-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
E. Faecalis Prevalence in Primary and Secondary Endodontic Infections: a Pre-post Microbial Analysis Following Chemo-mechanical Preparation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010485', 'term': 'Periapical Periodontitis'}], 'ancestors': [{'id': 'D010483', 'term': 'Periapical Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D010518', 'term': 'Periodontitis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'For each patient 4 samples will be taken with sterile paper cones: saliva sample before the endodontic treatment, canal sample pre and post treatment, negative control in the rubber dam.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-19', 'studyFirstSubmitDate': '2020-11-13', 'studyFirstSubmitQcDate': '2020-11-19', 'lastUpdatePostDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Correlation between E. Faecalis presence in the canal before the treatment and its presence in saliva (pre-treatment)', 'timeFrame': 'Pre-treatment microbial sampling in saliva was carried out 1 day before rubber dam isolation. Pre-treatment microbial sampling in the canal was carried out once arrived at working length with a 10 K-file.', 'description': 'Correlation between E. Faecalis presence in the canal before the treatment and its presence in saliva (pre-treatment) will be calculated'}, {'measure': 'Ability of the endodontic treatment to remove E. Faecalis from the canal', 'timeFrame': 'Pre-treatment microbial sampling in the canal was carried out 1 day once arrived at working length with a 10 K-file. Post treatment microbial sampling will be carried out at the end of the endodontic treatment after the final wash with EDTA and NaOCl', 'description': 'Pre-post endodontic treatment comparison as to E. Faecalis presence in the canal will be carried out'}, {'measure': 'Correlation between the presence of E. Faecalis in the canal before the treatment and the presence of a radiographic lesion', 'timeFrame': 'Pre-treatment microbial sampling in the canal was carried out 1 day once arrived at working length with a 10 K-file', 'description': 'Correlation between the presence of E. Faecalis in the canal before the treatment and the presence of a radiographic lesion (measured with the PAI score)'}], 'primaryOutcomes': [{'measure': 'Prevalence of E.Faecalis in the canal before the treatment for each group', 'timeFrame': 'Pre-treatment microbial sampling in the canal was carried out 1 day once arrived at working length with a 10 K-file', 'description': 'E.Faecalis prevalence in the canal before the treatment will be calculated for each group.'}], 'secondaryOutcomes': [{'measure': 'Correlation between E.Faecalis presence in the canal before the treatment and the pulpal/periapical status', 'timeFrame': 'Pre-treatment microbial sampling in the canal was carried out 1 day once arrived at working length with a 10 K-file', 'description': 'Correlation between E. faecalis presence in the canal before the treatment and the pulpal/periapical status for each group will be calculated through measures of association'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Apical Periodontitis']}, 'descriptionModule': {'briefSummary': 'Post-treatment apical periodontitis is a fairly prevalent condition frequently caused by a persistent endodontic infection due to failure of the endodontic treatment. Microbial species in treated or untreated root canals were found to be different, with the former being less diverse and mainly characterized by Gram positive, facultative anaerobes bacteria than the latter. Enterococcus faecalis is the most frequently detected species in root-filled teeth in many studies (Zhang et al., 2015). In fact, E. Faecalis retains many virulence factors allowing adhesion to host cells and extracellular matrix, tissue invasion and damage through toxins release, as well as the ability to survive even in harsh environmental conditions. Further studies are needed to clarify E. faecalis prevalence among the different forms of pulpal and periapical lesions as well as its correlation with clinical symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients in need of an endodontic treatment and meeting the inclusion/exclusion criteria will be eligible for the inclusion in the present study.', 'eligibilityCriteria': 'Inclusion criteria:\n\n* between the ages of 18 and 70;\n* good systemic health.\n* patients in need of an endodontic treatment/retreatment\n\nExclusion criteria:\n\n* taking antibiotic therapy in the previous 3 months;\n* presence of communication between the canal system and the oral cavity;\n* teeth that are not perfectly isolated;\n* teeth with probing depth \\>4 mm with positive BOP.'}, 'identificationModule': {'nctId': 'NCT04637659', 'briefTitle': 'E. Faecalis Prevalence in Primary and Secondary Endodontic Infections: a Pre-post Microbial Analysis Following Chemo-mechanical Preparation', 'organization': {'class': 'OTHER', 'fullName': 'University of Siena'}, 'officialTitle': 'E. Faecalis Prevalence in Primary and Secondary Endodontic Infections: a Pre-post Microbial Analysis Following Chemo-mechanical Preparation', 'orgStudyIdInfo': {'id': 'EF001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy non-treated teeth', 'description': 'Healthy teeth being treated for restorative or prosthodontics reasons', 'interventionNames': ['Procedure: Root Canal Treatment']}, {'label': 'Healthy treated teeth', 'description': 'Teeth being retreated for restorative or prosthodontics reasons', 'interventionNames': ['Procedure: Root Canal Treatment']}, {'label': 'Irreversible pulpitis', 'description': 'Teeth being treated because of a poor pulpal status', 'interventionNames': ['Procedure: Root Canal Treatment']}, {'label': 'Post-treatment apical periodontitis', 'description': 'Teeth being retreated due to the presence of an apical lesion', 'interventionNames': ['Procedure: Root Canal Treatment']}, {'label': 'Necrosis', 'description': 'Teeth being treated because of pulpal necrosis', 'interventionNames': ['Procedure: Root Canal Treatment']}], 'interventions': [{'name': 'Root Canal Treatment', 'type': 'PROCEDURE', 'description': "Chemo-mechanical preparation will be performed using reciprocating instruments . Irrigation will be carried out with 5.25% NaOCl during instrumentation and a final flush of 17% EDTA followed by 5.25% NaOCl. After drying with paper points, canal obturation will be achieved through continuous condensation wave technique. Obturation with gutta-percha will be performed using Reciproc blue R25 master cones and root canal sealer using the BeeFill 2 in 1 device (VDW, GmbH) with a small heat carrier (#40 tip size and .03 taper) following the manufacturer's instructions. After the down-packing phase, the back-filling will be performed with the same device and manual compaction using endodontic pluggers.", 'armGroupLabels': ['Healthy non-treated teeth', 'Healthy treated teeth', 'Irreversible pulpitis', 'Necrosis', 'Post-treatment apical periodontitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53100', 'city': 'Siena', 'country': 'Italy', 'facility': 'AOUS', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Siena', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Nicola Discepoli', 'investigatorAffiliation': 'University of Siena'}}}}