Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-26 @ 1:19 AM
Study NCT ID:
NCT06358833
Status:
COMPLETED
Last Update Posted:
2025-05-06
First Post:
2024-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Endodontic Postoperative Pain Using Different Irrigation Systems
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Patients will be masked from the procedure'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-03', 'studyFirstSubmitDate': '2024-04-07', 'studyFirstSubmitQcDate': '2024-04-07', 'lastUpdatePostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse event', 'timeFrame': 'During and immediately after root canal treatment', 'description': 'If any adverse event will occur, it will be recorded'}, {'measure': 'Rescue medication', 'timeFrame': 'Up-to 1 week postoperatively', 'description': 'In case of unbearable postoperative pain, the principal investigator will prescribe oral analgesic (ibuprofen 200 mg as the over-the-counter drug), and the timepoint of medication intake will be recorded.'}], 'primaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': '6 hours postoperatively', 'description': 'Postoperative pain will be measured using the Heft-Parker visual analog scale (VAS)'}, {'measure': 'Postoperative pain', 'timeFrame': '12 hours postoperatively', 'description': 'Postoperative pain will be measured using the Heft-Parker visual analog scale (VAS)'}, {'measure': 'Postoperative pain', 'timeFrame': '48 hours postoperatively', 'description': 'Postoperative pain will be measured using the Heft-Parker visual analog scale (VAS)'}, {'measure': 'Postoperative pain', 'timeFrame': '1 week postoperatively', 'description': 'Postoperative pain will be measured using the Heft-Parker visual analog scale (VAS)'}], 'secondaryOutcomes': [{'measure': 'Irrigation time', 'timeFrame': 'During root canal treatment', 'description': 'Time spent in irrigation procedures'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['root canal treatment', 'irrigation', 'ultrasonic activation', 'Endo1 Ultrasonic Endo Activate Device'], 'conditions': ['Postoperative Pain', 'Irreversible Pulpitis']}, 'descriptionModule': {'briefSummary': 'Summary:\n\nAfter a root canal procedure, it is common to experience postoperative pain. Cleaning the root canal thoroughly is crucial for pain relief, but removing all debris with standard methods is difficult. Irrigation, using either traditional endodontic needles or newer methods like endodontic activation, helps clean the canal. This study aims to compare pain levels after using conventional needles versus an Endo1 Ultrasonic Endo Activate Device for irrigation. Patients will undergo standard root canal preparation and then be randomly assigned to one of two groups for final irrigation: the Endo1 device (EA) and the conventional endodontic needles (EN). The study will provide insights into which method is more effective in reducing postoperative pain.', 'detailedDescription': 'Background:\n\nOne of the primary objectives following root canal therapy is to alleviate pain. While postoperative pain is undesirable, it is often considered a common sensation following endodontic treatment.\n\nCompletely removing all organic and inorganic debris from the root canal system to ensure the elimination of irritants that can cause postoperative pain is a challenging task, even when using precise rotary, hand, or hybrid instruments. Therefore, irrigation plays a crucial role in the cleaning and shaping process.\n\nTraditional root canal irrigation typically involves the use of an endodontic needle (EN) to disinfect the root canal. However, a newer approach called endodontic activation (EA) has been suggested to enhance root canal disinfection by activating irrigants within the canal.\n\nBoth of these methods of root canal irrigation are routine practice and part of the standard root canal treatment.\n\nRationale:\n\nNo study has directly compared the effects of final irrigation using conventional endodontic needles and an Endo1 Ultrasonic Endo Activate Device (Guilin Woodpecker, Guilin, China) on postoperative pain using a pragmatic approach. Therefore, the objective of this study is to assess and compare postoperative pain following the utilization of closed-ended endodontic needles and the Endo1 Ultrasonic Endo Activate Device during final root canal irrigation.\n\nStudy objectives:\n\nThe study aims to assess and compare the levels of postoperative pain following endodontic activation (EA) of irrigants using the Endo1 Ultrasonic Endo Activate Device (Guilin Woodpecker, Guilin, China) versus conventional endodontic needle (EN) irrigation in root canal therapy.\n\nMethods In this prospective single-blind, parallel-armed, randomized clinical trial, standard root canal preparation will be done; patients will be randomly assigned into one of the two groups. In the final irrigation protocol, group EA will go through activation using Endo1 Ultrasonic Endo Activate Device while patients in group EN will receive irrigation by conventional endodontic needle technique.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (\\>18 years of age) visiting the College of Dentistry and undergoing root canal treatment in posterior teeth (molars and premolars).\n* Teeth having fully formed roots with mature apices.\n* Patients willing to collaborate in the study must sign a written consent form.\n* Diagnosis of irreversible pulpitis in posterior tooth/teeth requiring root canal treatment.\n* No history of allergy to the anesthesia solution.\n* Classified as class I, II in the American Society of Anesthesiologists Physical Status Classification System.\n\nExclusion Criteria:\n\n* Patients diagnosed with pulp necrosis in the tooth require root canal treatment.\n* Mentally or medically compromised patients.\n* Pregnant women.\n* Patients on any medications for the past two weeks\n* Patients who refuse to participate in the study.\n* Patients with a history of allergy from any of the contents of local anesthesia or rubber dam material.\n* Non-restorable teeth'}, 'identificationModule': {'nctId': 'NCT06358833', 'briefTitle': 'Comparison of Endodontic Postoperative Pain Using Different Irrigation Systems', 'organization': {'class': 'OTHER', 'fullName': 'Qassim University'}, 'officialTitle': 'Comparison of Postoperative Pain When Using an Endodontic Needle and Endo1 Ultrasonic Endo Activate Device During Root Canal Irrigation: A Randomized Controlled Pragmatic Clinical Trial', 'orgStudyIdInfo': {'id': '24-82-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Endodontic needle (EN)', 'description': 'In this group, the irrigation of root canals will be done with 2.5 % sodium hypochlorite. The delivery of the irrigant will be done using 27G side-vented endodontic irrigation needles (Omega, Inc). The tip of the needle will be pre-measured and positioned within 1 millimeter of the working length. No activation of the irrigant will be performed.', 'interventionNames': ['Procedure: endodontic needle (EN)']}, {'type': 'EXPERIMENTAL', 'label': 'Endodontic activation (EA)', 'description': "In this group, the irrigation of root canals will be done with 2.5% sodium hypochlorite. The delivery of the irrigant will be done using 27G side-vented endodontic irrigation needles (Omega, Inc). The irrigant will be activated with ultrasonic energy using the Endo-1 Ultrasonic Endo Activator (Guilin Woodpecker, Guilin, China). The tip of the Endo-1 Ultrasonic Endo Activator device will be pre-measured and kept within 1 mm from the working length. The manufacturer's instructions regarding irrigant activation will be followed.", 'interventionNames': ['Procedure: Endodontic activation (EA)']}], 'interventions': [{'name': 'endodontic needle (EN)', 'type': 'PROCEDURE', 'description': 'the irrigation of root canals will be done with 2.5 % sodium hypochlorite. The delivery of the irrigant will be done using 27G side-vented endodontic irrigation needles (Omega, Inc). The tip of the needle will be pre-measured and positioned within 1 millimeter of the working length. No activation of the irrigant will be performed.', 'armGroupLabels': ['Endodontic needle (EN)']}, {'name': 'Endodontic activation (EA)', 'type': 'PROCEDURE', 'description': "the irrigation of root canals will be done with 2.5% sodium hypochlorite. The delivery of the irrigant will be done using 27G side-vented endodontic irrigation needles (Omega, Inc). The irrigant will be activated with ultrasonic energy using the Endo-1 Ultrasonic Endo Activator (Guilin Woodpecker, Guilin, China). The tip of the Endo-1 Ultrasonic Endo Activator device will be pre-measured and kept within 1 mm from the working length. The manufacturer's instructions regarding irrigant activation will be followed.", 'armGroupLabels': ['Endodontic activation (EA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58883', 'city': 'Ar Rass', 'state': 'Al-Qassim Region', 'country': 'Saudi Arabia', 'facility': 'Muhammad Zubair Ahmad', 'geoPoint': {'lat': 25.86944, 'lon': 43.4973}}], 'overallOfficials': [{'name': 'Muhammad Zubair Ahmad, FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Qassim University, Saudi Arabia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Sharing of IPD is subjected to further approval from the Committee of Research Ethics, the institutional review board (IRB) of Qassim University.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qassim University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Muhammad Zubair Ahmad', 'investigatorAffiliation': 'Qassim University'}}}}