Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-31 @ 7:47 PM
Study NCT ID:
NCT07084194
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-24
First Post:
2025-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Integrating Two Nano Based Irrigants With Two Activation Techniques in Treatment of Teeth With Acute Pulpitis on Postoperative Pain and Flare up Incidence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D000067251', 'term': 'Symptom Flare Up'}], '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'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-08-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-16', 'studyFirstSubmitDate': '2025-07-08', 'studyFirstSubmitQcDate': '2025-07-16', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative pain intensity Postoperative pain is to be assessed using visual analog scale (VAS), A scale from (0 to 10) where "0" means no pain and "10 means a severe pain that has never faced before.', 'timeFrame': '[Time Frame: 6, 12, 24, 48, 72 hours and 7 days after the first visit to collect the postoperative pain data.]', 'description': 'Patients will be contacted by phone at 6, 12, 24, 48, 72 hours and 7 days after the first visit to collect the postoperative pain data.'}], 'secondaryOutcomes': [{'measure': 'Flare-Up Incidence Flare-up is assessed through asking the patient to notify the investigator if any sudden severe pain or swelling takes place.', 'timeFrame': '[Time Frame: Within 7 days post-treatment)', 'description': 'This could require an unscheduled emergency visit or prescription of additional medication.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postoperative pain', 'flare up', 'nano-technology', 'irrigation', 'chitosan', 'aloe-vera'], 'conditions': ['Postoperative Pain', 'Flare up', 'Flare Up, Symptom']}, 'descriptionModule': {'briefSummary': 'This study aimed to evaluate and compare impact of integrating passive ultrasonic activation and laser activation with nano-chitosan and aloe vera in terms of postoperative pain and flare-up incidence in a randomized clinical trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-60 (adults only)\n* multiple-rooted with multiple root canal.\n* Permanent teeth with mature apex and complete root formation.\n* Without root caries.\n* Tooth must be restorable.\n* Without anatomical abnormalities such as fusion.\n* Healthy patient category I according to ASA.\n* Vital tooth, with acute irreversible pulpitis and without peri-apical periodontitis.\n* No periapical radiolucency.\n* Consent Patients for who consent to participate and attend follow-up appointments.\n\nExclusion Criteria:\n\n* single root canals or double root.\n* Root canal calcifications.\n* Root resorption or fracture.\n* Previously root canal treated teeth.\n* immunocompromised patients.\n* Pregnant females\n* Patients with systemic diseases as diabetic or hypertension patients.\n* Patients with facial swelling.\n* patients who use analgesics or antibiotics within 48-72 hours.\n* Allergy to any materials used (e.g., irrigants or anesthetics).\n* psychiatric illness\n* Teeth that are not indicated for endodontic treatment: bad oral hygiene, mobile teeth, or recessed teeth.\n* Previously endodontically treated teeth.\n* Teeth with sinus tract.'}, 'identificationModule': {'nctId': 'NCT07084194', 'briefTitle': 'Impact of Integrating Two Nano Based Irrigants With Two Activation Techniques in Treatment of Teeth With Acute Pulpitis on Postoperative Pain and Flare up Incidence', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Impact of Integrating Two Nano Based Irrigants With Two Activation Techniques in Treatment of Teeth With Acute Pulpitis on Postoperative Pain and Flare up Incidence: A Randomized Clinical Study', 'orgStudyIdInfo': {'id': 'EC Reaseach NO.1079'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GROUP I', 'description': 'treated with nanochitosan and passive ultrasonic activation', 'interventionNames': ['Other: Chitosan Nanoparticles Irrigant', 'Device: ultrasonic activator']}, {'type': 'EXPERIMENTAL', 'label': 'GROUP II', 'description': 'treated with nanochitosan and laser activation', 'interventionNames': ['Other: Chitosan Nanoparticles Irrigant', 'Device: Diode Laser Activation']}, {'type': 'EXPERIMENTAL', 'label': 'GROUP III', 'description': 'treated with nano-Aloe Vera and passive ultrasonic activation', 'interventionNames': ['Other: aloe vera nanoparticles irrigant', 'Device: ultrasonic activator']}, {'type': 'EXPERIMENTAL', 'label': 'GROUP IV', 'description': 'treated with nano-Aloe Vera and laser activation', 'interventionNames': ['Other: aloe vera nanoparticles irrigant', 'Device: Diode Laser Activation']}], 'interventions': [{'name': 'Chitosan Nanoparticles Irrigant', 'type': 'OTHER', 'description': 'using Chitosan Nanoparticles irrigant as a final irrigation solution.', 'armGroupLabels': ['GROUP I', 'GROUP II']}, {'name': 'aloe vera nanoparticles irrigant', 'type': 'OTHER', 'description': 'using Aloe Vera Nanoparticles irrigant as a final irrigation solution.', 'armGroupLabels': ['GROUP III', 'GROUP IV']}, {'name': 'Diode Laser Activation', 'type': 'DEVICE', 'description': 'activation of nanoparticles irrigants using diode laser', 'armGroupLabels': ['GROUP II', 'GROUP IV']}, {'name': 'ultrasonic activator', 'type': 'DEVICE', 'description': 'activation of nanoparticles irrigants using ultrasonic activator', 'armGroupLabels': ['GROUP I', 'GROUP III']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Rabee Ibrahaim Alhabibi', 'role': 'CONTACT', 'email': 'rabieibrahaim@gmail.com', 'phone': '+201018836570'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Rabee Alhabibi', 'investigatorFullName': 'Rabee Ibrahaim Ismail Alhabibi', 'investigatorAffiliation': 'Minia University'}}}}