Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-28 @ 10:28 AM
Study NCT ID:
NCT01201668
Status:
COMPLETED
Last Update Posted:
2011-09-20
First Post:
2010-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DPBRN Persistent Pain and Root Canal Therapy
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-16', 'studyFirstSubmitDate': '2010-09-13', 'studyFirstSubmitQcDate': '2010-09-13', 'lastUpdatePostDateStruct': {'date': '2011-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['post-operative pain', 'root canal therapy', 'feasibility', 'post-surgical persistent pain'], 'conditions': ['Root Canal Therapy', 'Persistent Tooth Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://DentalPBRN.org', 'label': 'Dental Practice-Based Research Network'}, {'url': 'http://DPBRN.org', 'label': 'Dental Practice-Based Research Network'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to document by survey the occurence of tooth pain present 3 months and 6 months after root canal therapy in the patients recruited for the DPBRN "Peri-operative tooth pain" study. This study will access the feasibility of obtaining 3 month and 6 month follow-up data on the patient enrolled in the DPBRN "Peri-operative tooth pain" study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The participants directly involved in this study are the patients who have sought dental treament in the practitioner-investigators' practices. The practitioner-investigators will be endodontists and general dentists.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 19-70 years old\n* Permanent adult tooth requiring its first non-surgical root canal therapy\n* patients with more than 1 tooth requiring root canal therapy are eligible, but only the first root canal procedure will be included to avoid problems of correlation within patients\n\nExclusion Criteria:\n\n* evidence of prior root canal therapy, including iatrogenic, but not disease-induced pulp access of the tooth being considered\n* patients with obvious cognitive impairments (e.g., past stroke with communication deficits, dementia,mental disability)\n* patients unable to return for 6 month follow-up'}, 'identificationModule': {'nctId': 'NCT01201668', 'briefTitle': 'DPBRN Persistent Pain and Root Canal Therapy', 'organization': {'class': 'NETWORK', 'fullName': 'Dental Practice-Based Research Network'}, 'officialTitle': 'Persistent Pain and Root Canal Therapy', 'orgStudyIdInfo': {'id': '133265'}, 'secondaryIdInfos': [{'id': 'U01DE016747', 'link': 'https://reporter.nih.gov/quickSearch/U01DE016747', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Persistent Tooth Pain'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294-0007', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida College of Dentistry', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '55440-1309', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Health Partners Dental Group', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55440-1524', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Health Partners Research Foundation', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '97227', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Kaiser Permanente Center for Health Research', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97232', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Permanente Denrtal Associates', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'University of Copenhagen Royal Dental College', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Donald R Nixdorf, DDS, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dental Practice-Based Research Network', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Institute of Dental and Craniofacial Research (NIDCR)', 'class': 'NIH'}, {'name': 'HealthPartners Institute', 'class': 'OTHER'}, {'name': 'Kaiser Permanente', 'class': 'OTHER'}, {'name': 'Permanente Dental Associates Group, Oregon', 'class': 'OTHER'}, {'name': 'University of Copenhagen', 'class': 'OTHER'}, {'name': 'University of Florida', 'class': 'OTHER'}, {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, {'name': 'University of Minnesota', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Chair, Department of General Dental Sciences', 'investigatorFullName': 'Gregg H. Gilbert, DDS, MBA, FAAHD', 'investigatorAffiliation': 'Dental Practice-Based Research Network'}}}}