Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-01-14 @ 2:34 PM
Study NCT ID:
NCT03105960
Status:
UNKNOWN
Last Update Posted:
2017-04-10
First Post:
2017-03-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Garlic With Lime Juice and Chlorhexidine Mouthwash
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005884', 'term': 'Gingival Hemorrhage'}], 'ancestors': [{'id': 'D006472', 'term': 'Oral Hemorrhage'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002710', 'term': 'Chlorhexidine'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'This was a double-blind study as the investigator was unaware about the sampling of the groups and study subjects were unaware about the mouthwash they were using'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A Randomized Clinical Trial parallel'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-04', 'studyFirstSubmitDate': '2017-03-21', 'studyFirstSubmitQcDate': '2017-04-04', 'lastUpdatePostDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'gingival bleading', 'timeFrame': '15 day', 'description': 'bleeding of gingiva asses by yes or no'}], 'secondaryOutcomes': [{'measure': 'Streptococcal count in saliva and plaque', 'timeFrame': '15 day', 'description': 'Streptococcal count in saliva and plaque'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gingival Bleeding']}, 'referencesModule': {'references': [{'pmid': '25728105', 'type': 'BACKGROUND', 'citation': 'Tulsani SG, Chikkanarasaiah N, Siddaiah SB, Krishnamurthy NH. The effect of Propolis and Xylitol chewing gums on salivary Streptococcus mutans count: a clinical trial. Indian J Dent Res. 2014 Nov-Dec;25(6):737-41. doi: 10.4103/0970-9290.152182.'}], 'seeAlsoLinks': [{'url': 'http://doi.org/10.4103/0970-9290.152182', 'label': 'Description related info'}]}, 'descriptionModule': {'briefSummary': 'the study about herbal mouthwash. it is clinical trial .the investigator will compare between chlorhexidine mouthwash and garlic with lime juice mouthwash.and their effect on gingival bleeding and plaque and salivary bacteria.', 'detailedDescription': 'the study about herbal mouth wash. it is clinical trial .the investigator will compare between chlorhexidine mouthwash and garlic with lime juice mouthwash.and show their effect on gingival bleeding and strepococcus bacteria present in saliva and plaque.\n\n1. Preparation of garlic with lime juice will occur under aseptic condition.and give it to the first group.\n\n provide chlorhexidine to the second group.\n2. Collection of plaque and saliva samples will be obtained from children who fulfilled the inclusion criteria.\n3. Asses gingival condition by asking patient.\n4. Subjects will be instructed to rinse for 14 days, twice daily.\n5. Morning after breakfast and night before going to bed.\n6. With 10 ml (undiluted) of the assigned mouthwash for 30 s and then expectorate the rinse.\n7. Again after 14 days, the saliva and plaque samples will be taken and inoculated on blood agar plates to determine the colony count and the gingival index by loe and illness will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '9 Years', 'genderBased': True, 'genderDescription': 'Egyptian children', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Children aged between 9 and 12 years.\n2. Children are having normal occlusion (no crowding), non-compromised oral health (brushed their teeth once-daily) using toothbrush and non-fluoridated toothpaste. And practicing no other oral hygiene measures.\n3. Medically free history.\n4. Absence of orthodontic appliances.\n\nExclusion criteria:\n\n1. History of current or recent (at least for the past 1 month) antibiotic usage or other medications.\n2. Presence of Abscess, draining sinus, cellulitis, or other conditions requiring emergency dental treatment.\n3. not willing to comply with the study.'}, 'identificationModule': {'nctId': 'NCT03105960', 'acronym': 'mouthwash', 'briefTitle': 'Garlic With Lime Juice and Chlorhexidine Mouthwash', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Evaluation of Garlic With Lime Juice and Chlorhexidine Mouthwash on Gingival Bleeding in Group of Egyptian Children: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '151087'}, 'secondaryIdInfos': [{'id': '151087', 'type': 'REGISTRY', 'domain': 'manal sayed'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'garlic with lime juice mouthwash', 'description': 'garlic with lime juice mouthwash is herbal antimicrobial .children were instructed to rinse for 14 days, twice daily, ,10 ml (undiluted) for 30 second and then expectorate .\n\nTo prepare garlic with lime mouth rinse, 100 g of fresh, washed garlic cloves was macerated in a sterile, ceramic mortar and water was added to obtain a homogenate which was then filtered off with a sterile muslin cloth. the final concentration of the solution was determined to be 1 g/100 ml. About 100 ml of lime juice was extracted from fresh lemons using a juice extractor and added to the garlic extract.', 'interventionNames': ['Drug: garlic with lime mouth wash']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'chlorhexidine mouthwash', 'description': 'chlorhexidine is antimicrobial, antiplaque mouthwash 10 ml (undiluted) for 30 second twice daily and then expectorate for 14 days. it is commercial mouthwash\n\n.', 'interventionNames': ['Drug: chlorhexidine']}], 'interventions': [{'name': 'garlic with lime mouth wash', 'type': 'DRUG', 'otherNames': ['herbal mouthwash'], 'description': 'garlic with lime juice is herbal antimicrobial 10 ml (undiluted) for 30s and then expectorate for 14 days.o prepare garlic with lime mouth rinse, 100 g of fresh, washed garlic cloves was macerated in a sterile, ceramic mortar and water was added to obtain a homogenate which was then filtered off with a sterile muslin cloth. the final concentration of the solution was determined to be 1 g/100 ml. About 100 ml of lime juice was extracted from fresh lemons using a juice extractor and added to the garlic extract.', 'armGroupLabels': ['garlic with lime juice mouthwash']}, {'name': 'chlorhexidine', 'type': 'DRUG', 'otherNames': ['antimicrobial mouthwash'], 'description': 'hlorhexidine is antimicrobial, antiplaque mouthwash 10 ml (undiluted) for 30 second twice daily and then expectorate for 14 days.', 'armGroupLabels': ['chlorhexidine mouthwash']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02', 'city': 'Helwan', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Manal Sayed Abdel Latief', 'geoPoint': {'lat': 29.84144, 'lon': 31.30084}}], 'overallOfficials': [{'name': 'sherif B eltweel, Ass.prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo univaesity'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'it will be available when it finish'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'oral and dental medicine', 'investigatorFullName': 'manal sayed abdel latief', 'investigatorAffiliation': 'Cairo University'}}}}