Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-30 @ 11:08 PM
Study NCT ID:
NCT06701266
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-22
First Post:
2024-11-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy of PoCT to ELISA by Detecting Human IL-6 in Teeth with Apical Periodontitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010485', 'term': 'Periapical Periodontitis'}], 'ancestors': [{'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-20', 'studyFirstSubmitDate': '2024-11-20', 'studyFirstSubmitQcDate': '2024-11-20', 'lastUpdatePostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detect the IL-6 in the exudate of the tooth with apical periodontitis', 'timeFrame': '1 week', 'description': 'Collection of exudate in Pre-instrumentation for PoCT and ELISA . After 1 week, collection of exudate in post-instrumentation for PoCT and ELISA will be done.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Apical Periodontitis']}, 'descriptionModule': {'briefSummary': 'To compare the diagnostic agreement of human IL-6 chairside PoCT to ELISA in apical periodontitis undergoing endodontic therapy which could be clinically helpful to monitor the healing of periapical tissues enabling the clinician to complete the endodontic procedure, leading to a better patient care.\n\nThis study will be conducted at the Conservative and Endodontics Department in Polyclinic B, Faculty of Dentistry, Manipal University College Malaysia (MUCM). It involves 30 selected patients who have single rooted tooth with apical periodontitis that undergo RCT. The collection of the exudate from the canal will be on pre and post-instrumentation. The exudated will collect twice in each instrumentation for PoCT and ELISA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '17 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient who is having apical periodontitis and undergo RCT in MUCM', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient having single root tooth with AP that is negative to the pulp sensitivity test\n* Presence of periapical lesion\n\nExclusion Criteria:\n\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT06701266', 'acronym': 'PoCT ELISA', 'briefTitle': 'Accuracy of PoCT to ELISA by Detecting Human IL-6 in Teeth with Apical Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'Manipal University College Malaysia'}, 'officialTitle': 'Diagnostic Agreement of Human Interleukin-6 Chairside Point-of-Care Test (PoCT) to Enzyme-Linked Immunosorbent Assay (ELISA) in Teeth with Apical Periodontitis', 'orgStudyIdInfo': {'id': 'MUCM/005D/11/2024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient have apical periodontitis', 'description': 'Patient have single rooted tooth with apical periodontitis that undergo RCT in MUCM.', 'interventionNames': ['Device: Point of Care Test']}], 'interventions': [{'name': 'Point of Care Test', 'type': 'DEVICE', 'description': 'PoCT as a chairside test, ELISA as a gold standard', 'armGroupLabels': ['Patient have apical periodontitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75150', 'city': 'Malacca', 'state': 'Melaka', 'country': 'Malaysia', 'facility': 'Manipal University College Malaysia', 'geoPoint': {'lat': 2.196, 'lon': 102.2405}}], 'centralContacts': [{'name': 'Anchu Rachel Thomas', 'role': 'CONTACT', 'email': 'rachel.thomas@manipal.edu.my', 'phone': '+6011-2729-2297'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Manipal University College Malaysia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Melaka Manipal Medical College', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated Professor of Conservative Dentistry & Endodontics', 'investigatorFullName': 'Dr. Anchu Rachel Thomas', 'investigatorAffiliation': 'Melaka Manipal Medical College'}}}}