Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:55 PM
Study NCT ID:
NCT03472456
Status:
COMPLETED
Last Update Posted:
2020-09-17
First Post:
2018-02-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Endodontic Medications for Irreversible Pulpitis: Articaine or Eugenol?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011671', 'term': 'Pulpitis'}, {'id': 'D014098', 'term': 'Toothache'}], 'ancestors': [{'id': 'D003788', 'term': 'Dental Pulp Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D005157', 'term': 'Facial Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003187', 'term': 'Compliance'}], 'ancestors': [{'id': 'D004548', 'term': 'Elasticity'}, {'id': 'D055595', 'term': 'Mechanical Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2019-10-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-16', 'studyFirstSubmitDate': '2018-02-12', 'studyFirstSubmitQcDate': '2018-03-20', 'lastUpdatePostDateStruct': {'date': '2020-09-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain evolution (decrease or increase the intensity of the pain)', 'timeFrame': '7 days', 'description': 'Evolution of pain (using a score of 0 to 10)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulpitides', 'Endodontic Inflammation', 'Toothaches', 'Operative Dentistry']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to determine which of the two commonly used endodontic medications (Eugenol VS Articaine) is most effective in controlling postoperative pain in irreversible pulpitis of the mature permanent tooth in adults. To do so, an assessment of the pain felt by patients will be carried out a few days apart. The supposed results are that the medications are equivalent in terms of effectiveness on the pain, but could then present different economic arguments', 'detailedDescription': "In irreversible pulpitis of the mature permanent tooth, the enrolled patients receive endodontic medications (Eugenol or Articaine) in order to determine which one is the more efficient to control the pain.\n\nThese patients would have received the same medication without this study. That's why this is an obsevationnal study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from the University Hospital (Dental Service) of Strasbourg (HUS)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient, major, affiliated to a social health insurance scheme\n* Patient having agreed to participate in the study\n* Urgent consultant patient for irreversible pulpitis\n* Patient understanding French\n\nExclusion Criteria:\n\n* Refusal of the patient to participate in the study\n* Impossibility of performing the surgical procedure\n* Impossibility to give the subject information enlightened (difficulty of understanding ...)\n* Subject under the protection of justice, or under guardianship\n* General contraindication to endodontic treatment in 2 sessions (high risk of infectious endocarditis, for example)\n* Chronic intake of analgesic drugs'}, 'identificationModule': {'nctId': 'NCT03472456', 'briefTitle': 'Endodontic Medications for Irreversible Pulpitis: Articaine or Eugenol?', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Articaine or Eugenol: a Study on the Choice of Endodontic Medication in the Emergency Management of Irreversible Pulpitis of a Mature Permanent Tooth', 'orgStudyIdInfo': {'id': '6953'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Articaïne', 'interventionNames': ['Drug: Implementation of a pulp medication in compliance with the dental emergency management protocol: articaïne']}, {'label': 'Eugénol', 'interventionNames': ['Drug: Implementation of a pulp medication in compliance with the dental emergency management protocol: eugenol']}], 'interventions': [{'name': 'Implementation of a pulp medication in compliance with the dental emergency management protocol: articaïne', 'type': 'DRUG', 'description': 'Implementation of a pulp medication in compliance with the dental emergency management protocol: articaïne', 'armGroupLabels': ['Articaïne']}, {'name': 'Implementation of a pulp medication in compliance with the dental emergency management protocol: eugenol', 'type': 'DRUG', 'description': 'Implementation of a pulp medication in compliance with the dental emergency management protocol: eugenol', 'armGroupLabels': ['Eugénol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Les Hôpitaux Universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'overallOfficials': [{'name': 'Damien OFFNER', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Les Hôpitaux Universitaires de Strasbourg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}