Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-29 @ 5:01 AM
Study NCT ID:
NCT05801367
Status:
COMPLETED
Last Update Posted:
2023-04-06
First Post:
2023-02-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Allium Sativum Oil as Alternative Non-vital Pulpotomy Medicament in Primary Teeth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019553', 'term': 'Tooth, Nonvital'}], 'ancestors': [{'id': 'D003788', 'term': 'Dental Pulp Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C031025', 'term': 'formocresol'}, {'id': 'C038491', 'term': 'allyl sulfide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'patients and assessors involved in the study from randomization, allocation, bacteriological outcome, and data analysis will be blinded to which medicament group the patients belonged as all data will be coded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-24', 'studyFirstSubmitDate': '2023-02-28', 'studyFirstSubmitQcDate': '2023-03-24', 'lastUpdatePostDateStruct': {'date': '2023-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antibacterial effect', 'timeFrame': '1 week', 'description': 'Bacterial count of S. mutans and L. acidophilus counted as Colony Forming Units/ml (CFU/ml)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-Vital Tooth']}, 'descriptionModule': {'briefSummary': 'The purpose of this randomized controlled clinical trial is to use Allium sativum oil as non-vital Pulpotomy medicament compared to Formocresol in primary teeth by evaluating its antibacterial effect against Streptococcus mutans and Lactobacillus acidophilus. It is hypothesized that there is no difference in the antibacterial effect of Allium sativum oil compared with Formocresol, when used as non-vital Pulpotomy medicaments.', 'detailedDescription': 'It is a multi-arm parallel Randomized Controlled Trial in which forty patients aged between 4 to 8 years, each containing at-least one non-vital primary molar, will be selected and randomly divided into Group A (Formocresol) and Group B (Allium sativum oil). Non-vital Pulpotomy will be performed by removing the coronal necrotic pulp. Sterile paper point will be dipped in the root canals and taken to the laboratory. Cotton pellets soaked in the respective medicaments will be placed over the root canal orifices and filled temporarily. Patients will be recalled after one week. Samples will be again taken, and tooth restored. Comparison between bacterial count at baseline and after one week of treatment will be made and expressed as Colony-Forming Units/ml (CFU/ml).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Cooperation of patients and consent of parents.\n2. Patients with ASA classification I and II (mild to moderate systemic disease).\n3. Non-traumatic extensively carious hence restorable primary molars.\n4. No history of antibiotic use for 2 weeks.\n5. Presence of following clinical signs or symptoms suggestive of non-vital tooth such as tenderness on percussion, non-responsive to cold test, periapical/furcal radiolucency, localized gingival/mucosal soreness/redness/swelling, and/or slight mobility-grade I.\n\nExclusion Criteria:\n\n1. History of allergy to anesthetics and latex.\n2. Radiographic evidence of pulpal floor opening into the furcation area.\n3. More than half of the roots resorbed.'}, 'identificationModule': {'nctId': 'NCT05801367', 'briefTitle': 'Allium Sativum Oil as Alternative Non-vital Pulpotomy Medicament in Primary Teeth', 'organization': {'class': 'OTHER', 'fullName': 'University of Health Sciences Lahore'}, 'officialTitle': 'Allium Sativum Oil as Alternative Non-vital Pulpotomy Medicament in Primary Teeth- A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'UniversityUHS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Formocresol (Control-Gold standard-Group A)', 'description': 'Premade Formocresol (Tricresol \\& Formalin) will be used in this research. Composition was Tricresol 35%, Formaldehyde (40%) 19%, excipient additive 100% (PD, Switzerland, ISO9001/ISO9001\\_2000/ ISO13485/CE\\_MARK), (Universal Dental Pvt, Ltd)', 'interventionNames': ['Drug: Formocresol']}, {'type': 'EXPERIMENTAL', 'label': 'Allium sativum oil (Experimental-Group B)', 'description': 'Premade Allium sativum oil (Garlic oil) (Mohammad and Baroudi, 2015b) will be used in this research (SAC group of companies-9001:2015 certified; Registration # PAK17.1724-U; NTN # 0299739-8, Karachi, Pakistan', 'interventionNames': ['Drug: Allium Sativum Oil']}], 'interventions': [{'name': 'Formocresol', 'type': 'DRUG', 'otherNames': ['medicament for Non-vital pulpotomy procedure'], 'description': 'Formocresol will be used as non-vital pulpotomy medicament (which is gold standard)', 'armGroupLabels': ['Formocresol (Control-Gold standard-Group A)']}, {'name': 'Allium Sativum Oil', 'type': 'DRUG', 'otherNames': ['medicament for Non-vital pulpotomy procedure'], 'description': 'Allium sativum oil will be used as non-vital pulpotomy medicament compared with Formocresol (which is gold standard)', 'armGroupLabels': ['Allium sativum oil (Experimental-Group B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': "de' Montmorency College of dentistry", 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'Shazia Naz, BDS, MDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant professor operative dentistry de, Montmorency College of Dentistry'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Health Sciences Lahore', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lahore General Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dental Surgeon (Ex-Postgraduate trainee)', 'investigatorFullName': 'Dr. Mashal Mazhar', 'investigatorAffiliation': 'University of Health Sciences Lahore'}}}}