Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-01-03 @ 8:39 PM
Study NCT ID:
NCT04115904
Status:
UNKNOWN
Last Update Posted:
2019-10-04
First Post:
2019-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Pain Rate of Single Versus Two-visit Root Canal Treatment of Teeth With Necrotic Pulps
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007052', 'term': 'Ibuprofen'}, {'id': 'D003759', 'term': 'Dental Implantation, Endosseous, Endodontic'}], 'ancestors': [{'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003758', 'term': 'Dental Implantation, Endosseous'}, {'id': 'D003757', 'term': 'Dental Implantation'}, {'id': 'D013516', 'term': 'Oral Surgical Procedures, Preprosthetic'}, {'id': 'D019647', 'term': 'Oral Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}, {'id': 'D004708', 'term': 'Endodontics'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D011476', 'term': 'Prosthodontics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'compare Incidence of acute painafter single-visit ortwo-visits treatment of teeth with necrotic pulp'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '110 teeth with a diagnosis of pulp necrosis and apical radiolucency at the apex.Working length was established with EAL and confirmed radiographically. M4system with Flex-R files were used to complete canal preparation. Level ofdiscomfort were recorded and cases with severe postoperative pain'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-09-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-03', 'studyFirstSubmitDate': '2019-10-02', 'studyFirstSubmitQcDate': '2019-10-03', 'lastUpdatePostDateStruct': {'date': '2019-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity measure with general pain scale', 'timeFrame': 'a week', 'description': 'Each patient will recall a week to evaluate post operative pain'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'Aim to compare acute pain rate after single-visit ortwo-visits treatment of teeth with necrotic pulp and apical periodontitis .90 teeth with a diagnosis of pulp necrosis and apical radiolucency at the apex.Working length was established with EAL and confirmed radiographically. Flex-R files were used to complete canal preparation. Level ofdiscomfort were recorded and cases with acute postoperative pain.', 'detailedDescription': '90 teeth with a diagnosis of pulp necrosis and apical radiolucency at the apex.Working length was established with EAL and confirmed radiographically. M4system with Flex-R files were used to complete canal preparation. Level ofdiscomfort were recorded and cases with severe postoperative pain and/orswelling were classified as acute pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Patients from 18-65 years, both: male , fenale', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: a) Radiographic evidence of apical periodontitis (minimum size ≥2.0mm x 2.0 mm) and a diagnosis of pulpal necrosis confirmed by negativeresponse to hot and cold tests and b) Need for retreatment. Thermal pulptesting was performed by the author, and radiographic interpretation wasverified by one certified oral surgeon\n\n\\-\n\nExclusion Criteria:\n\n* patients without inclusion requirements or failure to obtain patient ́sauthorization. Patients, were excluded if they were younger than 18 yearsold, pregnant, had a positive history of antibiotic use within the past month,suffered from diabetes, or other systemic diseases. Teeth with periodontalpockets deeper than 4 mm also were excluded of the study'}, 'identificationModule': {'nctId': 'NCT04115904', 'acronym': 'Acute pain', 'briefTitle': 'Acute Pain Rate of Single Versus Two-visit Root Canal Treatment of Teeth With Necrotic Pulps', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Autonoma de Baja California'}, 'officialTitle': 'Acute Pain Rate of Single Versus Two-visit Root Canal Treatment of Teeth With Necrotic Pulp and Apical Periodontitis: A Multicenter Clinical Trial', 'orgStudyIdInfo': {'id': '2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Post-endodontic Pain after a RCT', 'description': 'Ibuprofen for Post operative pain. Take 400 mg takena week after. Incidence of flare ups after a single vsmultiple visits root canal treatments.', 'interventionNames': ['Procedure: Ibuprofen for post operative pain']}, {'type': 'EXPERIMENTAL', 'label': 'Acute pain', 'description': 'Acetaminophen 325 mg for Acute pain. Taken secondday after. Incidence of Post operative pain after rootcanal treatment in one vs two visits', 'interventionNames': ['Procedure: Ibuprofen for post operative pain']}], 'interventions': [{'name': 'Ibuprofen for post operative pain', 'type': 'PROCEDURE', 'otherNames': ['Endodontic therapy'], 'description': 'All treatment sessions were approximately 45 minutes in length to allow for acceptable time for completionof treatment and retreatment in one or two visits. Allthe clinical procedures were performed by the author.Following local anesthesia with 2% lidocaine with1:100,000 epinephrine (Septodont Saint-Maur desFossés, France) and rubber dam isolation the toothwas disinfected with 5.25% NaOCl (Ultra bleach,Bentonville, AR, USA).', 'armGroupLabels': ['Acute pain', 'Post-endodontic Pain after a RCT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22000', 'city': 'Tijuana', 'state': 'Baja Califronia', 'country': 'Mexico', 'facility': 'Jorge Paredes Vieyra', 'geoPoint': {'lat': 32.5027, 'lon': -117.00371}}, {'zip': '22000', 'city': 'Tijuana', 'state': 'Estado de Baja California', 'country': 'Mexico', 'facility': 'Jorge Paredes Vieyra', 'geoPoint': {'lat': 32.5027, 'lon': -117.00371}}, {'zip': '22000', 'city': 'Tijuana', 'state': 'Estado de Baja California', 'country': 'Mexico', 'facility': 'Jose Clemente Orozco', 'geoPoint': {'lat': 32.5027, 'lon': -117.00371}}, {'zip': '22000', 'city': 'Tijuana', 'state': 'Estado de Baja California', 'country': 'Mexico', 'facility': 'Jose Clemente', 'geoPoint': {'lat': 32.5027, 'lon': -117.00371}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Acute pain rate', 'ipdSharing': 'YES', 'description': 'Each participant will be evaluated a week after the treatment', 'accessCriteria': 'Evaluate the acute pain rate'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Autonoma de Baja California', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Jorge Paredes Vieyra DDS, MsC, PhD', 'investigatorFullName': 'Jorge Paredes Vieyra', 'investigatorAffiliation': 'Universidad Autonoma de Baja California'}}}}