Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 1:14 PM
Study NCT ID:
NCT07453134
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-05
First Post:
2026-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment Outcome and Patient-reported Outcomes in Patient Undergoing Non-surgical Root Canal Treatment With Different Irrigation Protocols
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-03', 'studyFirstSubmitDate': '2026-02-23', 'studyFirstSubmitQcDate': '2026-03-03', 'lastUpdatePostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success and survival rate, Post-operative pain, OHIP-14 Score', 'timeFrame': '"From enrollment to the end of treatment at 1 year"', 'description': '1. Success rate At the 1-year follow-up visit, the dentist will perform a clinical and radiographic examination, A calibrated researcher that blinded to the treatment procedures and irrigation activation methods, will interpret the radiographs using the criteria established by Friedman and Mor (2004)\n\n \\- Survival rate = Tooth is functional and remains in the mouth.\n2. Post-operative pain will be assessed using the Numerical Rating Scale (NRS), with scores recorded before treatment (baseline) and after complete treatment. In cases treated over two visits, pain scores will be record\n3. Oral health-related quality of life will be evaluated using the OHIP-14 questionnaires recorded before treatment (baseline) and after complete treatment.'}], 'secondaryOutcomes': [{'measure': 'Prognostic factors affecting treatment outcomes', 'timeFrame': '"From enrollment to the end of treatment at 1 year"', 'description': 'Some factors associated to treatment outcomes will be analyzed such as age, gender, tooth type, tooth diagnosis, activated irrigation methods, quality of root canal treatment, quality of coronal restoration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Laser-activated Irrigation', 'Oral Health-Related Quality of Life', 'Post-Operative pain'], 'conditions': ['Root Canal Treatment', 'Irrigation Activation', 'Oral Health Quality of Life (OHQoL) Was Assessed', 'Post Operative Pain After Root Canal Therapy']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate and compare the clinical and patient-reported outcomes of passive ultrasonic irrigation (PUI) and laser-activated irrigation (LAI) versus conventional syringe irrigation in adult patients undergoing non-surgical root canal treatment on mature permanent teeth, and to identify the key factors that influence these outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All permanent teeth diagnosed with any of the following conditions including irreversible pulpitis (symptomatic and asymptomatic), pulp necrosis, previously initiated therapy with or without apical periodontitis o Patients with age 18-80\n* Patients with Thai ethnicity\n* Patients who could read and communicate in Thai language\n* Patients with well-controlled medical conditions according to ASA I and II classification\n\nExclusion Criteria:\n\n* The tooth with cracks, incomplete root formation, vertical or horizontal root fractures or root resorption\n* The tooth with periodontal pocket depth of 5 mm or more, degree of mobility of 2 or more\n* Patients with bone metabolism disease and/or using steroids or bisphosphonates, immunosuppressed, history of radiotherapy, pregnancy o Patients with serious medical conditions that required consultation with a physician before root canal treatment\n* Patients who refuse to participate or could not answer the questionnaires'}, 'identificationModule': {'nctId': 'NCT07453134', 'briefTitle': 'Treatment Outcome and Patient-reported Outcomes in Patient Undergoing Non-surgical Root Canal Treatment With Different Irrigation Protocols', 'organization': {'class': 'OTHER', 'fullName': 'Chulalongkorn University'}, 'officialTitle': 'Treatment Outcome and Impact on Oral Health-related Quality of Life in Patient Undergoing Non-surgical Root Canal Treatment With Different Irrigation Protocols: Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'HREC-DCU 2025-148'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Conventional needle irrigation'}, {'type': 'EXPERIMENTAL', 'label': 'Passive ultrasonic irrigation', 'interventionNames': ['Procedure: root canal treatment and intracanal medicament']}, {'type': 'EXPERIMENTAL', 'label': 'Laser-activated irrigation', 'interventionNames': ['Procedure: root canal treatment and intracanal medicament']}], 'interventions': [{'name': 'root canal treatment and intracanal medicament', 'type': 'PROCEDURE', 'description': 'Laser-activated irrigation', 'armGroupLabels': ['Laser-activated irrigation']}, {'name': 'root canal treatment and intracanal medicament', 'type': 'PROCEDURE', 'description': 'Passive ultrasonic irrigation', 'armGroupLabels': ['Passive ultrasonic irrigation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Chulalongkorn University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chulalongkorn University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}