Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2026-02-11 @ 6:43 AM
Study NCT ID:
NCT06509295
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-19
First Post:
2024-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Calcium Hypochlorite Versus Sodium Hypochlorite as Root Canal Irrigants on Postoperative Pain and Bacterial Reduction in Mandibular Premolars With Necrotic Pulps. .
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C004488', 'term': 'calcium hypochlorite'}, {'id': 'D012388', 'term': 'Root Canal Irrigants'}], 'ancestors': [{'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D019551', 'term': 'Dental Disinfectants'}, {'id': 'D004202', 'term': 'Disinfectants'}, {'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08-29', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-05-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-13', 'studyFirstSubmitDate': '2024-06-24', 'studyFirstSubmitQcDate': '2024-07-13', 'lastUpdatePostDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of Calcium Hypochlorite Versus Sodium Hypochlorite as Root Canal Irrigants on Postoperative Pain in Mandibular Premolars with Necrotic Pulps.', 'timeFrame': 'measured at 6, 12, 24, 48 hours after single visit treatment', 'description': 'measuring tool: Numerical Rating Scale (NRS). Unite of measurement: Categorical None 0 Mild 1-3 Moderate 4-6 Severe 7-10 Time of measurements: At 6, 12, 24, 48- hours post-treatment.'}], 'secondaryOutcomes': [{'measure': 'Effect of Calcium Hypochlorite Versus Sodium Hypochlorite as Root Canal Irrigants on Bacterial Reduction in Mandibular Premolars with Necrotic Pulps.', 'timeFrame': 'T0=Baseline immediate after access preparation . T1=Post-instrumentation. T1(within an hour)', 'description': 'Intracanal bacterial load reduction will be determined by bacterial counting using agar culture technique after root canal preparation (CFUs/ml), The growth will be semi quantitatively determined as very heavy, heavy, moderate, sparse and very sparse depending on the CFU ranging from \\>100,000,˂100,000,˂10,000,˂1,000, ˂100 colony forming unit per 1 ml BHI respectively.'}, {'measure': 'Number of analgesic tablets taken by the patient after endodontic treatment', 'timeFrame': 'Up to 48 hours postoperative.', 'description': 'Number of analgesic tablets taken by the patient after endodontic treatment Up to 48 hours postoperative.\n\nMeasuring tool: counting Measurment unite: numerical.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intervention']}, 'descriptionModule': {'briefSummary': 'This study aims to assess the effect of Calcium Hypochlorite Versus Sodium Hypochlorite as Root Canal Irrigants on Postoperative Pain and Bacterial Reduction in Mandibular Premolars with Necrotic Pulps.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Systematically healthy patient (ASA I, II).\n2. Age between 20 and 55 years\n3. Male or female.\n4. Mandibular premolar teeth having single canals diagnosed with pulp necrosis with asymptomatic apical periodontitis.\n5. Radiographic examination using Digora intraoral periapical sensor plate and software showing mandibular premolars with (0-2 mm) periapical radiolucency.\n\nExclusion Criteria:\n\n1. Medically compromised patients having significant systemic disorders. (ASA III or IV).\n2. History of intolerance to NSAIDS.\n3. Teeth with:\n\n * Immature roots\n * Vital pulp tissues.\n * Association with swelling.\n * Acute peri-apical abscess or acute exacerbation of a chronic abscess.\n * Mobility Grade II or III.\n * Previously accessed or endodontically treated\n * Deep periodontal pockets more than 4 mm\n * Vertical root fractures, coronal perforation, calcification, and external or internal root resorptions.\n4. Patients who could not interpret the NRS.\n5. Patients with diabetes, immune-compromising, and immunosuppression disease and pregnant women were, also, excluded.'}, 'identificationModule': {'nctId': 'NCT06509295', 'briefTitle': 'Effect of Calcium Hypochlorite Versus Sodium Hypochlorite as Root Canal Irrigants on Postoperative Pain and Bacterial Reduction in Mandibular Premolars With Necrotic Pulps. .', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Calcium Hypochlorite Versus Sodium Hypochlorite as Root Canal Irrigants on Postoperative Pain and Bacterial Reduction in Mandibular Premolars With Necrotic Pulps. A Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'ENDO 3-7-1(10/4/2024)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Calcium Hypochlorite as root canal Irrigant on Postoperative Pain and bacterial load reduction', 'description': 'Treatment with Calcium Hypochlorite as root canal Irrigant', 'interventionNames': ['Other: Calcium Hypochlorite as Root Canal Irrigant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sodium Hypochlorite as a root Canal Irrigant', 'description': 'Treatment with Sodium Hypochlorite as root canal Irrigant', 'interventionNames': ['Other: Calcium Hypochlorite as Root Canal Irrigant']}], 'interventions': [{'name': 'Calcium Hypochlorite as Root Canal Irrigant', 'type': 'OTHER', 'description': 'Calcium Hypochlorite used as root canal irrigant during chemo-mechanical preparation', 'armGroupLabels': ['Calcium Hypochlorite as root canal Irrigant on Postoperative Pain and bacterial load reduction', 'Sodium Hypochlorite as a root Canal Irrigant']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Youmna Yassen Youmna Yassen, pds', 'role': 'CONTACT', 'email': 'youmna_yassen@dentistry.cu.edu.eg', 'phone': '01146877037'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator, resident at faculty of dentistry', 'investigatorFullName': 'Youmna Yassen', 'investigatorAffiliation': 'Cairo University'}}}}