Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT04655105
Status:
UNKNOWN
Last Update Posted:
2021-03-30
First Post:
2020-12-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Post Operative Pain Following Reciprocating and Rotary Heat-treated NiTi Instrumentation of Root Canals: a Randomized Controlled Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-06-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-29', 'studyFirstSubmitDate': '2020-12-03', 'studyFirstSubmitQcDate': '2020-12-03', 'lastUpdatePostDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'post operative pain evaluation using different rotary instruments: VAS score', 'timeFrame': 'at 24 hrs', 'description': 'pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced \\[1-3\\] mild pain , \\[4-7\\] moderate pain , \\[8-10\\] severe pain'}, {'measure': 'post operative pain evaluation using different rotary instruments: VAS score', 'timeFrame': 'at 48hrs', 'description': 'pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced \\[1-3\\] mild pain , \\[4-7\\] moderate pain , \\[8-10\\] severe pain'}, {'measure': 'post operative pain evaluation using different rotary instruments: VAS score', 'timeFrame': 'at 7 days', 'description': 'pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced \\[1-3\\] mild pain , \\[4-7\\] moderate pain , \\[8-10\\] severe pain'}], 'secondaryOutcomes': [{'measure': 'assessment of pain scale using different rotary instruments', 'timeFrame': 'through study completion, an average of 1 week', 'description': 'pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced \\[1-3\\] mild pain , \\[4-7\\] moderate pain , \\[8-10\\] severe pain'}, {'measure': 'comparing the pain scale experienced between male and female in VAS score', 'timeFrame': 'through study completion, an average of 1 week', 'description': 'pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced \\[1-3\\] mild pain , \\[4-7\\] moderate pain , \\[8-10\\] severe pain'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Root Canal Infection']}, 'descriptionModule': {'briefSummary': 'The present clinical evaluation was planned for comparing the post-operative pain incidence in maxillary premolar teeth with acute irreversible pulpitis treated by recently introduced heat treated TruNatomy TM and other widely studied heat-treated files Hyflex EDM, Protaper Gold and one heat-treated reciprocating EdgeFile in single-visit root canal treatment.', 'detailedDescription': 'Essential component of successful root canal treatment is removal of pulp tissue remnants, microorganisms, and microbial toxins from root canal system. Machine assisted root canal preparation allows for faster and easier instrumentation. Flexible nickel-titanium (NiTi) root canal files have become indispensible with technological advancements in metallurgy and incorporation of several design features manufacturers have attempted to improve the efficiency of these instruments. 1 Thermomechanically treated NiTi has a modified phase composition compared to conventional NiTi files. These files contain varying amounts of R-phase and martensite in their alloy composition in clinical conditions. Increased proportion of martensite phase allows for more flexible files with enhanced cyclic fatigue resistance. Simultaneously endodontic motor have undergone significant enhancements regarding torque control and kinematics that are adjustable in several directions. 1 Yared (2008) introduced the concept of single file reciprocation which was based on balanced-force technique. Reciprocation motion have been shown to increase the cyclic fatigue resistance of NiTi instruments, also these motions have been associated with increased debris extrusion and post treatment discomfort. Recently TruNatomy TM files has been introduced with manufacturers claims of 0.8mm slim wire NiTi design with superior flexibility, off-centered cross-section, special heat-treated NiTi wire and regressive taper allowing for preservation of dentin and tooth integrity.\n\nPost operative pain following root canal treatment is influenced by number of factors; root canal file system and rotary kinetics on incidence and intensity of post-operative pain has been conflicting with certain evidence favoring full rotary motion whilst others recommend reciprocating motion. Sun et al. (2018) in their systematic review concluded that different type of full rotary root canal NiTi file system did not have significant influence on post-root canal treatment pain and reciprocation motion was associated with increased post treatment discomfort. These scientific studies involved comparing both conventional NiTi and heat-treated files.\n\nIn this scenario the present clinical evaluation was planned for comparing the post-operative pain incidence in maxillary premolar teeth with acute irreversible pulpitis treated by recently introduced heat treated TruNatomy TM and other widely studied heat-treated files Hyflex EDM, Protaper Gold and one heat-treated reciprocating EdgeFile in single-visit root canal treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion criteria included maxillary premolars with radiograph evidence of decay approximating the pulp with sound periodontal health.\n\nExclusion Criteria:\n\n* Exclusion criteria were patients not willing for recall visits, teeth not amenable to post-endodontic restoration, teeth with periapical radiolucencies, presence of additional roots or canal variations from conventional maxillary premolar anatomy, two or more adjacent teeth requiring root canal treatment, absence of occlusal contacts, premolars not sufficiently anaesthetized with 2 mL of local anesthetic solution, teeth with difficult canal anatomy (curvatures \\> 30°, radiograph evidence of pulp chamber and canal calcification, open apices) immunocomprimised patients, patients systemic ailments hindering single-visit root canal treatment and pregnant patients.'}, 'identificationModule': {'nctId': 'NCT04655105', 'briefTitle': 'Evaluation of Post Operative Pain Following Reciprocating and Rotary Heat-treated NiTi Instrumentation of Root Canals: a Randomized Controlled Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Tamil Nadu Dr.M.G.R.Medical University'}, 'officialTitle': 'Evaluation of Post Operative Pain Following Reciprocating and Rotary Heat-treated NiTi Instrumentation of Root Canals: a Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'TamilNadu'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Truanatomy rotary file', 'description': 'use of tru anatomy rotary files root canal instrumentation followed by post operative pain evaluation', 'interventionNames': ['Device: root canal rotary files']}, {'type': 'EXPERIMENTAL', 'label': 'hyflex EDM rotary file', 'description': 'use of hyflex EDM rotary files root canal instrumentation followed by post operative pain evaluation', 'interventionNames': ['Device: root canal rotary files']}, {'type': 'EXPERIMENTAL', 'label': 'edge endo reciprocating rotary file', 'description': 'use of edge endo reciprocating rotary files root canal instrumentation followed by post operative pain evaluation', 'interventionNames': ['Device: root canal rotary files']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'protaper gold rotary file', 'description': 'use of protaper gold rotary files root canal instrumentation followed by post operative pain evaluation', 'interventionNames': ['Device: root canal rotary files']}], 'interventions': [{'name': 'root canal rotary files', 'type': 'DEVICE', 'description': 'post operative pain evaluation using different rotary file system', 'armGroupLabels': ['Truanatomy rotary file', 'edge endo reciprocating rotary file', 'hyflex EDM rotary file', 'protaper gold rotary file']}]}, 'contactsLocationsModule': {'locations': [{'zip': '625001', 'city': 'Madurai', 'state': 'Tamil Nadu', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Anand Sherwood', 'role': 'CONTACT', 'email': 'anand.sherwood@gmail.com', 'phone': '9791443950'}, {'name': 'Valliappan C.T, post graduate', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CSI college of dental sciences and research', 'geoPoint': {'lat': 9.919, 'lon': 78.11953}}], 'centralContacts': [{'name': 'Valliappan CT, post graduate (MDS)', 'role': 'CONTACT', 'email': 'vrvalliappan2@gmail.com', 'phone': '08870558925'}, {'name': 'Anand Sherwood, MDS, Ph.D', 'role': 'CONTACT', 'email': 'anand.sherwood@gmail.com', 'phone': '9791443950'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tamil Nadu Dr.M.G.R.Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'post graduate student', 'investigatorFullName': 'Valliappan CT', 'investigatorAffiliation': 'Tamil Nadu Dr.M.G.R.Medical University'}}}}