Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-01-03 @ 6:44 AM
Study NCT ID:
NCT06894069
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-26
First Post:
2025-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intracanal Dexamethasone Extrusion and Postoperative Endodontic Pain
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': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2025-01-23', 'studyFirstSubmitQcDate': '2025-03-23', 'lastUpdatePostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative pain following root canal treatment', 'timeFrame': 'at 12, 24, 48 and 72 hours after completing the treatment', 'description': 'The outcome measure is patient-reported pain following root canal treatment. Patients will be given a questionnaire to complete, on 4 different time intervals following the completion of their root canal treatment (12, 24, 48 and 72 h). For each time interval, patients will be asked to fill out:\n\n1. their perceived pain level on a standard 100mm visual-analogue scale, with pain values ranging from zero (no pain at all) and ascending gradually until 100 (worst imagined pain).\n2. Whether they needed to take any analgesics. In this case, details about the type, route, dose and timing of the analgesic taken will have to be filled out'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Root canal treatment', 'Post-operative pain', 'Corticosteroids', 'Dexamethasone', 'Randomised controlled trial'], 'conditions': ['Post Operative Pain Control', 'Endodontic Treatment']}, 'descriptionModule': {'briefSummary': 'The aim of this research is to assess the effect of intentionally extruding a corticosteroid intracanal solution into the periapical tissues on the postoperative pain after root canal treatment in patients with symptomatic irreversible pulpitis and symptomatic apical periodontitis (SIP/SAP). The main question it aims to answer: Is there an analgesic effect of extruding an intracanal solution of DXA into the periapical tissues in patients diagnosed with SIP/SAP? Researchers will compare dexamethasone to a placebo to see if the extrusion dexamethasone works in reducing post-endodontic treatment pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A diagnosis of irreversible pulpits with symptomatic apical periodontitis\n* Adult patients (aged 18 - 70)\n* Healthy patients or those with a well-controlled disease (ASA I \\& II)\n\nExclusion Criteria:\n\n* A diagnosis of necrotic pulp, or normal apical tissues\n* Patients with a severe systemic disease (ASA III or higher)\n* Patients who received analgesics12 hours before presentation\n* Previously treated/initiated Endodontics treatment on the same tooth\n* Unopposed teeth\n* Third molar teeth\n* Non-restorable teeth\n* Periodontally compromised teeth\n* Pregnant or lactating patients'}, 'identificationModule': {'nctId': 'NCT06894069', 'briefTitle': 'Intracanal Dexamethasone Extrusion and Postoperative Endodontic Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Jordan'}, 'officialTitle': 'Effect of Intentional Extrusion of an Intracanal Corticosteroid Solution on Post Endodontic Treatment Pain: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '10/2023/ 32001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DXM', 'description': 'Patients in this group will receive a standard root canal treatment but with the extra step of extruding a Dexamethasone (DXM) solution through the root canals to the periradicular tissues prior to obturation.', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'description': 'Patients in this group will receive a standard root canal treatment with saline used as the final irrigating solution prior to obturation.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'a 2 ml solution of dexamethasone (3.3mg/ml) will be flushed in the root canal and intentionally extruded to the periradicular tissues to assess its potnetial sedative effect', 'armGroupLabels': ['DXM']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '2ml of normal saline will be used as placebo to be flushed and extruded through the canals to the periradicular tissues', 'armGroupLabels': ['Saline']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Renad H Khanfer', 'role': 'CONTACT', 'email': 'renad_hazem@hotmai.com', 'phone': '+962795101571'}, {'name': "Ahmad M El Ma'aita", 'role': 'CONTACT', 'phone': '+962799552225'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jordan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Renad Hazem Khanfer', 'investigatorAffiliation': 'University of Jordan'}}}}