Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 2:39 AM
Study NCT ID:
NCT07420920
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-19
First Post:
2026-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antibacterial Effect and Post-operative Pain Following Various Techniques of Intracanal Heating of NaOCL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-11-05', 'size': 1774163, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2026-02-11T10:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-11', 'studyFirstSubmitDate': '2026-02-03', 'studyFirstSubmitQcDate': '2026-02-11', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bacterial reduction', 'timeFrame': 'after treatment, samples are sent to microbiology lab and bacterial count is measured day 1 after treatment.', 'description': 'Antibacterial effect is evaluated by counting number of bacterial colonies, samples are collected and placed in brain-heart infusion (BHI) broth and subjected to microbiological analysis to determine the colony-forming unit (CFU)/ml'}], 'secondaryOutcomes': [{'measure': 'Post-operative pain', 'timeFrame': 'Post operative pain is measured until day 3 after treatment', 'description': 'Postoperative pain is assessed for each patient using Visual Analog Scale (VAS) with a score ranging from 0 (no pain) to 10 (unbearable pain)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Necrotic teeth,', 'Endodontic irriggation', 'Irrigation activation', 'Intracanal heating', 'Sodium hypochlorite'], 'conditions': ['Necrotic Teeth']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Govindaraju, L., Shruthi, S.T., Gopal, R., Jenarthanan, S., Rajendran, M.R., 2024. Does increase in temperature of sodium hypochlorite have enhanced antimicrobial efficacy and tissue dissolution property?-A systematic review and meta-regression. J. Conserv. Dent. Endod. 27, 675-684. https://doi.org/10.4103/JCDE.JCDE_110_24'}, {'type': 'BACKGROUND', 'citation': 'Iandolo, A., Amato, M., Dagna, A., Poggio, C., Abdellatif, D., Franco, V., Pantaleo, G., 2018. Intracanal heating of sodium hypochlorite: Scanning electron microscope evaluation of root canal walls. J. Conserv. Dent. 21, 569. https://doi.org/10.4103/JCD.JCD_245_18'}, {'type': 'BACKGROUND', 'citation': 'Rathore, V., Samel, D., Moogi, P., Bandekar, S., Kshirsagar, S., Vyas, C., 2020. Antimicrobial efficacy of intracanal and extracanal heated sodium hypochlorite against Enterococcus faecalis: An in vitro study. Endodontology 32, 112-117. https://doi.org/10.4103/endo.endo_21_20'}, {'type': 'BACKGROUND', 'citation': 'Yared, G., Al Asmar Ramli, G., 2020. Antibacterial Ability of Sodium Hypochlorite Heated in the Canals of Infected Teeth: An Ex Vivo Study. Cureus. https://doi.org/10.7759/cureus.6975'}, {'type': 'BACKGROUND', 'citation': 'Simeone, M., Valletta, A., Giudice, A., Di Lorenzo, P., Iandolo, A., 2015. The activation of irrigation solutions in Endodontics: A perfected technique. G. Ital. Endod. 29, 65-69. https://doi.org/10.1016/j.gien.2015.08.005'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to is to assess the antibacterial effect of sodium hypochlorite heated inside root canals of necrotic teeth using various activation techniques\n\nThe main question it aims to answer is:\n\nDoes the antibacterial effect vary following various standardized techniques of intracanal heating of sodium hypochlorite in endodontic treatment?', 'detailedDescription': 'Root canal treatment success depends on the removal of necrotic and vital pulp tissues and bacteria and bacterial byproducts from the root canal system.\n\nMechanical cleansing and removal of necrotic or vital pulp tissue lead to the formation of a layer of debris called " Smear layer," which is made of organic and inorganic substances that should be removed from the root canal system with the help of irrigants.\n\nThe presence of complex anatomy like isthmi and anastomoses makes chemical cleansing of the root canal system difficult because they are filled with the smear layer.\n\nThe ideal features of root canal irrigants include cleansing, lubrication of endodontic instruments and root canal system, dissolution of inorganic and organic tissues, antimicrobial properties, absence of cytotoxicity without alteration of dental microstructure. Sodium hypochlorite (NaOCl) has been the most widely used irrigant in endodontics due to its antimicrobial and tissue-dissolving action.\n\nDue to the presence of complex anatomy inside the root canal system, activation of irrigation is essential to improve the cleaning of such a complex system. Ultrasonic activation is presently the most popular method for activation of irrigation. It delivers the irrigant farther into areas of the root canal system untouched by instruments, and it improves the mechanical cleaning by increasing the wall shear stress.\n\nNaOCl is used in concentrations between 0.5% - 6%. In high concentrations, it may have a faster dissolution capacity, but it is associated with toxicity in cases of extrusion; thus, methods to improve the action of less concentrated solutions become relevant, such as agitation of the irrigant, constant refreshment and volume, and heating of the solution. Using NaOCl solution at high temperature is related to an increase in reactivity and, therefore, a reduction in bacterial counts and bacterial biofilm dissolution. Although the dentin acts as a thermal insulator, the excessive increase in temperature could dissipate to the periapical tissues, causing damage to the bone tissue .\n\nInitially, it was suggested to heat NaOCl before inserting it into the canals, but this was of little effectiveness .\n\nWoodmansey demonstrated that NaOCl solution can dissolve pulp tissue 210 times faster at boiling temperature (90-120°C) than at room temperature. However, this method remained limited due to the lack of studies confirming its safety until Simeone et al. confirmed that when NaOCl solution is heated inside the canals at a temperature of 150°C for 10 seconds, the temperature of the periodontal tissues does not rise above 42.5°C, which is within the acceptable limits for the periodontal tissue.\n\nIntracanal heating to 180°C using System-B Heat Source shows better antibacterial efficacy than preheated sodium hypochlorite at 60°C. Also, it has been suggested to use low-concentration NaOCl at elevated temperature to report the evidence for better antimicrobial and tissue dissolution properties.\n\nA combination of these two activation methods by ultrasonic agitation of sodium hypochlorite, followed by intracanal heating, may have promising results with regard to the removal of bacteria.\n\nPatients frequently encounter postoperative pain after root canal treatment, and one of the causes is that NaOCl at a higher concentration is irritant to surrounding tissue, particularly in the case of extrusion. Irrigation using lower concentration NaOCl was effective in reducing postoperative pain.\n\nBased on the previous studies, studying the effect of irrigation using low concentration NaOCl (2.6%), which can be activated to increase its reactivity, could give predectible antibacterial effect while reducing postoperative pain and toxicity associated with extrusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor patients:\n\n* adult male or female patients\n* medically free.\n\nFor selected teeth:\n\n* asymptomatic necrotic single rooted teeth\n* teeth with mature root\n* restorable teeth.\n\nExclusion Criteria:\n\nFor patients:\n\n* Patients with dental related symptoms\n* patients with chronic or systemic diseases\n* pregnant females.\n\nFor selected teeth:\n\n* multirooted teeth\n* vital teeth\n* teeth with incompletely formed roots\n* teeth with internal or external resorption\n* previously root canal treated teeth'}, 'identificationModule': {'nctId': 'NCT07420920', 'briefTitle': 'Antibacterial Effect and Post-operative Pain Following Various Techniques of Intracanal Heating of NaOCL', 'organization': {'class': 'OTHER', 'fullName': 'Misr University for Science and Technology'}, 'officialTitle': 'Assessment of the Antibacterial Effect and Post-operative Pain Following Various Techniques of Intracanal Heating of Sodium Hypochlorite: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '2024/0042'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intracanal heating for activation using ultrasonics', 'interventionNames': ['Device: Ultrasonic activation']}, {'type': 'EXPERIMENTAL', 'label': 'Intracanal heating for activation using System-B heat carrier', 'interventionNames': ['Device: System-B']}, {'type': 'EXPERIMENTAL', 'label': 'Intracanal heating for activation using a combination of ultrasonics and System-B', 'interventionNames': ['Device: System-B', 'Device: Ultrasonic activation']}], 'interventions': [{'name': 'System-B', 'type': 'DEVICE', 'description': 'The irrigation activation by heating is achieved using System-B heat carrier', 'armGroupLabels': ['Intracanal heating for activation using System-B heat carrier', 'Intracanal heating for activation using a combination of ultrasonics and System-B']}, {'name': 'Ultrasonic activation', 'type': 'DEVICE', 'description': 'Activation of irrigation using ultrasonic', 'armGroupLabels': ['Intracanal heating for activation using a combination of ultrasonics and System-B', 'Intracanal heating for activation using ultrasonics']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Misr University for Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Alaa El din Yasser Mohamed Salah Eldin', 'investigatorAffiliation': 'Misr University for Science and Technology'}}}}