Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 7:44 PM
Study NCT ID:
NCT07388368
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-05
First Post:
2025-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Evaluation of Post Obturation Pain After Root Canal Treatment Using Tricalcium Silicate vs Resin-Based Sealers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C534916', 'term': 'epoxy resin-based root canal sealer'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-12-05', 'size': 1266338, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2025-12-07T12:18', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A comparative evaluation of postobturation pain after root canal treatment using tricalcium silicate versus resin-based sealers in cases with symptomatic irreversible pulpitis'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 118}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-30', 'studyFirstSubmitDate': '2025-12-07', 'studyFirstSubmitQcDate': '2026-01-30', 'lastUpdatePostDateStruct': {'date': '2026-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain after root canal treatment assessed using a Visual Analogue Scale (VAS)', 'timeFrame': '24 hours, 72 hours and 7 days', 'description': 'Postoperative pain will be recorded using a 10-centimeter Visual Analogue Scale (VAS). On this scale, 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores correspond to greater pain intensity, meaning more pain. Patients will self-report their pain level at each time point (24 hours, 72 hours, and 7 days). This measure will be used to compare postoperative pain between patients treated with Endoplus resin-based sealer and CeraSeal bioceramic sealer.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['root canal sealar', 'postobturation pain', 'bioceramic sealer', 'resin based sealar'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled trial comparing the mean and standard deviation of postobturation pain using two different sealers: a tricalcium silicate-based sealer (CeraSeal) and a resin-based sealer (Endoplus) in patients with symptomatic irreversible pulpitis undergoing root canal treatment.', 'detailedDescription': '• The study will be conducted after approval from the Institutional Ethics Review Committee of the Armed Forces Institute of Dentistry. Informed written consent will be obtained from all patients, and demographic details (name, age, gender, and contact information) will be collected. This is a randomized clinical trial, and the sample size will be divided into two groups using computer-generated randomization. Group 1 will receive Endoplus (resin-based sealer), and Group 2 will receive CeraSeal (bioceramic sealer).\n\nAll root canal procedures will be performed by the principal investigator. At the first visit, local anesthesia (2% lignocaine with 1:100,000 epinephrine) and rubber dam isolation will be used. Working length will be determined using an apex locator and confirmed with a periapical radiograph. Chemo-mechanical preparation will be performed using 2.5% sodium hypochlorite (NaOCl) and 17% ethylenediaminetetraacetic acid (EDTA). Cleaning and shaping will be done up to F2 ProTaper using hand files and nickel-titanium (NiTi) rotary files, with recapitulation between each file to maintain canal patency. Non-setting calcium hydroxide will be placed as an intracanal medicament, followed by a temporary restoration with Cavit. Patients will be recalled after one week for obturation and will proceed only if asymptomatic.\n\nAt the second visit, obturation will be carried out according to group allocation. Group 1 will receive Endoplus resin-based sealer using a single-cone gutta-percha technique with a heated plugger (System B). Group 2 will receive CeraSeal bioceramic sealer with matched bioceramic cones using the same System B technique. Accessory cones will be used for wide or irregular canals. A permanent composite restoration (Coltene) will be placed, and occlusion will be adjusted.\n\nPostoperative pain will be recorded using a Visual Analogue Scale (VAS) at 24 hours, 72 hours, and 7 days. Ibuprofen will be prescribed only if the pain becomes unbearable, and patients will document the dose and frequency taken. Two independent blinded endodontists will evaluate radiographs for technical errors or sealer extrusion. The primary measure of success will be the level of postoperative pain at follow-up, comparing outcomes between Endoplus resin-based sealer and CeraSeal bioceramic sealer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Patients of age group 18 to 60 years\n\n * Healthy patients with ASA class 1 and 2\n * Patients of both genders\n * Teeth diagnosed as symptomatic irreversible pulpitis\n * Single as well as multirooted teeth\n\nExclusion Criteria:\n\n* Teeth with calcified or previously treated canals\n* Immunocompromised or mentally handicapped patients\n* Pregnant or lactating mothers\n* Teeth with periodontal probing depths of 5 mm or more\n* Cracked or un restorable teeth\n* Teeth where root canal instrumentation could not reach within 2 mm of the radiographic apex'}, 'identificationModule': {'nctId': 'NCT07388368', 'briefTitle': 'Comparative Evaluation of Post Obturation Pain After Root Canal Treatment Using Tricalcium Silicate vs Resin-Based Sealers', 'organization': {'class': 'OTHER', 'fullName': 'Armed Forces Institute of Dentistry, Pakistan'}, 'officialTitle': 'A Comparative Evaluation of Post Obturation Pain After Root Canal Treatment Using Tricalcium Silicate Versus Resin-based Sealers in Cases With Symptomatic Irreversible Pulpitis', 'orgStudyIdInfo': {'id': 'Protocol-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tricalcium silicate based sealer (Bio ceramic)', 'description': 'CeraSeal bioceramic sealer will be used for obturation with matched bioceramic cones and a heated plugger (System B).', 'interventionNames': ['Drug: Tricalcium silicate sealar']}, {'type': 'EXPERIMENTAL', 'label': 'Resin based sealer', 'description': 'Endoplus resin-based sealer will be used for obturation with single-cone gutta-percha and a heated plugger (System B)', 'interventionNames': ['Drug: Resin based sealer']}], 'interventions': [{'name': 'Tricalcium silicate sealar', 'type': 'DRUG', 'otherNames': ['CeraSeal sealer, bioceramic sealer, calcium silicate sealer'], 'description': 'Ceraseal (bioceramic sealer) - assigned to Group 2', 'armGroupLabels': ['Tricalcium silicate based sealer (Bio ceramic)']}, {'name': 'Resin based sealer', 'type': 'DRUG', 'otherNames': ['Endoplus sealer, resin sealer, gutta-percha sealer'], 'description': 'Endoplus (resin-based sealer) - assigned to Group 1', 'armGroupLabels': ['Resin based sealer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46000', 'city': 'Rawalpindi', 'state': 'Punjab Province', 'country': 'Pakistan', 'contacts': [{'name': 'Pooja Kumari', 'role': 'CONTACT', 'email': 'dhomejapooja@gmail.com', 'phone': '03133422793'}], 'facility': 'Armed Force Institute of Dentistry', 'geoPoint': {'lat': 33.59733, 'lon': 73.0479}}], 'centralContacts': [{'name': 'Pooja Kumari', 'role': 'CONTACT', 'email': 'dhomejapooja@gmail.com', 'phone': '03133422793'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual Participant Data (IPD) will not be shared with other researchers because this trial involves a small patient sample, and the data contains identifiable clinical information that cannot be fully anonymized without compromising patient confidentiality. The dataset is intended solely for analysis within the approved research protocol, as permitted by the Institutional Ethics Review Committee. Therefore, IPD sharing is not planned.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Armed Forces Institute of Dentistry, Pakistan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Pooja Kumari, Principal Investigator and Resident, Operative Dentistry and Endodontics', 'investigatorFullName': 'Pooja Kumari', 'investigatorAffiliation': 'Armed Forces Institute of Dentistry, Pakistan'}}}}