Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT06081335
Status:
COMPLETED
Last Update Posted:
2023-11-15
First Post:
2023-09-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Can Instrumentation Kinematics Affect Post Operative Pain and Substance P Levels? A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D010485', 'term': 'Periapical Periodontitis'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010483', 'term': 'Periapical Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D010518', 'term': 'Periodontitis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-13', 'studyFirstSubmitDate': '2023-09-25', 'studyFirstSubmitQcDate': '2023-10-11', 'lastUpdatePostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'difference in substance P levels', 'timeFrame': 'pre-operatively and after 5 days at the beginning of the second visit', 'description': 'tested by radioimmunacy (ELISA)'}, {'measure': 'post operative pain levels', 'timeFrame': 'pre-operative, after 6 hours, 12 hours , 24 hours, 48 hours, 72 hours', 'description': 'Numerical Rating Scale was used to assess pain where 0 is no pain and 10 is the worst possible pain'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pain', 'substance P', 'continuous rotation', 'reciprocation'], 'conditions': ['Pain, Postoperative', 'Irreversible Pulpitis', 'Apical Periodontitis']}, 'referencesModule': {'references': [{'pmid': '38233887', 'type': 'DERIVED', 'citation': 'Abdel-Baset ST, Fahmy SH, Obeid MF. Can instrumentation kinematics affect postoperative pain and substance P levels? A randomized controlled trial. BMC Oral Health. 2024 Jan 17;24(1):102. doi: 10.1186/s12903-024-03882-x.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to evaluate the effect of continuous rotation and reciprocation kinematics on post operative pain and difference in substance P levels in patients with irreversible pulpitis with symptomatic apical periodontitis. Twenty patients were randomly distributed into two groups; Continuous Rotation group(n=10): received mechanical preparation using EdgeEndo x7 rotary system (Albuquerque, New Mexico, USA), while Reciprocation group(n=10): received mechanical preparation using EdgeOne Fire reciprocating system (Albuquerque, New Mexico, USA). Apical fluid(AF) samples were collected, and substance P (SP) levels were measured using radioimmunoassay and postoperative pain was measured using Numerical Rating Scale (NRS) preoperatively, at 6h, 12h, 24h, 48h and 72h.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Single rooted mandibular second premolar teeth with complete root formation\n* Pulpal diagnosis: Symptomatic irreversible pulpitis\n* Periapical diagnosis: symptomatic apical periodontitis with no visible periapical radiolucent area\n* Patients with pre-operative pain records above 4 on Numerical Rating Scale (NRS) to ensure standardization\n\nExclusion Criteria:\n\n1. The presence of any systemic disease or allergic reactions\n2. Pregnant and lactating females\n3. Patients on antibiotic or anti-inflammatory medication\n4. Use of analgesics a week prior to treatment\n5. A radiographically untraceable canal or an excessively curved root\n6. The presence of periapical radiolucency or sinus tract.\n7. Teeth with open apices\n8. Severe periodontal disease (generalized or localized to the tooth in question)\n9. Absence of bleeding in the pulp chamber on access cavity preparation\n10. Internal or external resorption'}, 'identificationModule': {'nctId': 'NCT06081335', 'briefTitle': 'Can Instrumentation Kinematics Affect Post Operative Pain and Substance P Levels? A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Can Instrumentation Kinematics Affect Post Operative Pain and Substance P Levels? A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '945'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Continuous Rotation group', 'description': 'EdgeEndo x7 continuous rotation files system (Albuquerque, New Mexico, USA)', 'interventionNames': ['Device: EdgeEndo x7 continuous rotation files']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reciprocation group', 'description': 'EdgeOne Fire reciprocating files system (Albuquerque, New Mexico, USA)', 'interventionNames': ['Device: EdgeOne Fire reciprocating files']}], 'interventions': [{'name': 'EdgeEndo x7 continuous rotation files', 'type': 'DEVICE', 'description': 'endodontic files operating in continuous rotation', 'armGroupLabels': ['Continuous Rotation group']}, {'name': 'EdgeOne Fire reciprocating files', 'type': 'DEVICE', 'description': 'endodontic files operating in reciprocating motion', 'armGroupLabels': ['Reciprocation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11765', 'city': 'Cairo', 'state': 'Select A State Or Province', 'country': 'Egypt', 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'zip': '11765', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'maram obeid', 'role': 'STUDY_CHAIR', 'affiliation': 'professor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Salma Talaat', 'investigatorAffiliation': 'Ain Shams University'}}}}