Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-28 @ 12:34 PM
Study NCT ID:
NCT05657132
Status:
UNKNOWN
Last Update Posted:
2022-12-20
First Post:
2022-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antibacterial Effect of New Herbal Paste Used as an Intracanal Medication
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized control trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-10', 'studyFirstSubmitDate': '2022-12-10', 'studyFirstSubmitQcDate': '2022-12-10', 'lastUpdatePostDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bacterial count', 'timeFrame': '1 weak', 'description': 'Colony forming unit'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['infected primary molars, metapaste, herbal paste'], 'conditions': ['Infection Primary']}, 'descriptionModule': {'briefSummary': 'studying the antibacterial effect of Cosuts paste as an intracanal medication against Enterococcus faecalis that present in necrotic primary teeth', 'detailedDescription': 'The children were randomly divided into two groups (I, II) Group I (N=12): using Costus-based paste as an intracanal medicament. Group II (N= 12): Calcium hydroxide iodoform paste (Metapex) as an intracanal medicament.\n\nProcedure:\n\nAccess opening was started. then a swab was taken from the distal root canal with a dry paper point and transferred to a sterile test tube. The canals were filled with an intracanal medication according to the patient group. In group I, the canals was filled with a previously prepared Costus-based paste for one week, and In Group II, the canals were filled with Meta paste for one week. After 1 week, the paste was washed away from the canals then another swab was taken from the distal canal by a dry paper point as done before preoperatively.\n\nThe 2 swabs were transferred within 2 hours to the lab for bacterial culture and detection of enterococcus faecalis count.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with clinically and radiologically diagnosed infected primary teeth in their mandibular arch.\n* Teeth should be deeply carious, with a history of spontaneous pain and carious exposures with necrotic pulp was also be selected\n* radiographic evidence of adequate alveolar bone support, and absence of internal or external resorption.\n* tooth must be restorable.\n\nExclusion Criteria:\n\n* vital tooth\n* Non restorable teeth'}, 'identificationModule': {'nctId': 'NCT05657132', 'briefTitle': 'Antibacterial Effect of New Herbal Paste Used as an Intracanal Medication', 'organization': {'class': 'OTHER', 'fullName': 'Nahda University'}, 'officialTitle': 'Antibacterial Effect of New Herbal Paste Used as an Intracanal Medication in Necrotic Primary Molars, a Randomized Control Trial', 'orgStudyIdInfo': {'id': '050622'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Costus paste', 'description': 'Costus paste used as an intracanal medication for decreasing the number of enterococcus faecalis present in the necrotic root of the primary molar', 'interventionNames': ['Drug: herbal intracanal medication paste']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'metapaste', 'description': 'metapaste used as an intracanal medication for decreasing the number of enterococcus faecalis present in the necrotic root of the primary molar', 'interventionNames': ['Drug: Meta paste']}], 'interventions': [{'name': 'herbal intracanal medication paste', 'type': 'DRUG', 'otherNames': ['herbal paste'], 'description': 'study the effect of costus herbal paste on enterococcus faecalis bacteria', 'armGroupLabels': ['Costus paste']}, {'name': 'Meta paste', 'type': 'DRUG', 'otherNames': ['control paste'], 'description': 'compare the effect of Costus paste with meta paste in reducing the number of enterococcus faecalis', 'armGroupLabels': ['metapaste']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'Bani Suif', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ghada Salem, Ph.D', 'role': 'CONTACT', 'email': 'ghadamohamedalirana@hotmail.com', 'phone': '+201005144561'}, {'name': 'Mariem Elmansy', 'role': 'CONTACT', 'email': 'drmaryamelmansy@hotmail.com', 'phone': '01223355029'}], 'facility': 'NUB University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Ghada Salem, Ph.D', 'role': 'CONTACT', 'email': 'ghadamohamedalirana@hotmail.com', 'phone': '+201005144561'}, {'name': 'Mariem Elmansy', 'role': 'CONTACT', 'email': 'drmaryamelmansy@hotmail.com', 'phone': '01223355029'}], 'overallOfficials': [{'name': 'Ghada Salem, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'associate professor of Pediatric Dentistry'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'not to share IPD until publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nahda University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Pediatric Dentistry', 'investigatorFullName': 'GHada Abdelwahab Ahmed', 'investigatorAffiliation': 'Nahda University'}}}}