Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2026-01-04 @ 4:57 PM
Study NCT ID:
NCT05623605
Status:
UNKNOWN
Last Update Posted:
2022-12-14
First Post:
2022-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of New Different Herbal Mouthwashes Against Caries Forming Bacteria, RCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-12', 'studyFirstSubmitDate': '2022-11-12', 'studyFirstSubmitQcDate': '2022-11-18', 'lastUpdatePostDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bacterial count', 'timeFrame': '1 weak', 'description': 'decrease the count of streptococus mutans after use of the herbal mouthwash'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Moringa', 'Star Anis', 'Indian Costus', 'Mouth wash', 'Streptococus Mutans'], 'conditions': ['Dental Caries in Children']}, 'descriptionModule': {'briefSummary': 'The goal of this randomized controlled trial is to compare three different types of mouthwash, Moringa, Star anis, and Indian Costus 90 children participated in this study divided into 3 groups according to the type of mouthwash used and then subdivided in each group into 3 subgroups according to the concentration of the mouthwash 5,10,15%. the children were asked to rinse with the mouthwash 3 times per day for 1 week. bacterial count for streptococcus mutans was measured before and after the use of mouthwash to see the most effective concentration.', 'detailedDescription': 'The powdered of Moringa, Star anis, and Indian Costus leaves (250 g) were extracted using 90% ethanol then filtered using Whatman Filter paper No.1 and dried under reduced pressure using rota vapor. The crude ethanolic extract was (200 mg). ninety children will be randomly distributed into three groups (1,2,3) (30 children each). each group was divided into further 3 groups (10 children each) according to the concentration of each herbal mouthwash (5,10,15%). each participant will be given a new bottle of a specific effective amount of herbal extract to be used as a mouthwash. Children will be instructed to rinse with 5ml of mouthwash. All groups were instructed to rinse three times a day with specific mouthwash for each group for about one minute and participants will be advised to use the mouthwash for seven days. Collection of saliva samples Prior to the start of the experiment, samples of unstimulated saliva were taken when the child spit a suitable amount of unstimulated saliva in a sterile container in the morning before breakfast. Initial salivary samples were collected to establish base levels (S1) using selective culture media, The salivary samples (S2) were collected after one week of using the mouthwash when the child spit a suitable amount of unstimulated saliva in a sterile container in the morning before breakfast.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\- Children with no systemic disease, no history of recent antibiotic administration (last 2 weeks), antimicrobial mouth-rinse (last 12 hours), topical fluoride treatment within 4 weeks prior to baseline, children with no untreated active carious lesion, no orthodontic appliance or with low caries index (DMF\\& def \\< 4)\n\nExclusion Criteria:\n\n* Children using antibiotics, medications or mouthwashes at the time of the study, children with oral or systemic disease, children undergoing any dental treatment'}, 'identificationModule': {'nctId': 'NCT05623605', 'briefTitle': 'Evaluation of New Different Herbal Mouthwashes Against Caries Forming Bacteria, RCT', 'organization': {'class': 'OTHER', 'fullName': 'Nahda University'}, 'officialTitle': 'Evaluation of Antibacterial Potency of New Different Herbal Mouthwashes Against Caries Forming Bacteria, a Randomized Control Trial', 'orgStudyIdInfo': {'id': '040522'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Moringa mouthwash', 'description': '5 ml Moringa mouthwash two times per day for 1 week', 'interventionNames': ['Drug: Moringa mouthwash']}, {'type': 'EXPERIMENTAL', 'label': 'Star Anis mouthwash', 'description': '5 ml Star Anis mouthwash two times per day for 1 week', 'interventionNames': ['Drug: star anise mouthwash']}, {'type': 'EXPERIMENTAL', 'label': 'Indian Costus mouthwash', 'description': '5 ml Indian Costus mouthwash two times per day for 1 week', 'interventionNames': ['Drug: Indian costus mouth wash']}], 'interventions': [{'name': 'Moringa mouthwash', 'type': 'DRUG', 'otherNames': ['Moringa herbal mouthwash'], 'description': 'using Moringa mouthwashes in 3 different concentrations (5,10,15%) twice per day for 7 days', 'armGroupLabels': ['Moringa mouthwash']}, {'name': 'star anise mouthwash', 'type': 'DRUG', 'otherNames': ['star anise herbal mouthwash'], 'description': 'using star anise mouthwash in 3 different concentrations (5,10,15%) twice per day for 7 days', 'armGroupLabels': ['Star Anis mouthwash']}, {'name': 'Indian costus mouth wash', 'type': 'DRUG', 'otherNames': ['Indian costus herbal mouth wash'], 'description': 'using Indian costus mouthwash in 3 different concentrations (5,10,15%) twice per day for 7 days', 'armGroupLabels': ['Indian Costus mouthwash']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11728', 'city': 'Maadi', 'state': 'Cairo Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ghada Salem, Ph.D', 'role': 'CONTACT', 'email': 'ghadamohamedalirana@hotmail.com', 'phone': '+201005144561'}], 'facility': 'Ghada Salem', 'geoPoint': {'lat': 29.95958, 'lon': 31.25924}}], 'centralContacts': [{'name': 'Ghada Salem, Ass. Professor', 'role': 'CONTACT', 'email': 'ghada.abdelwahab@nub.edu.eg', 'phone': '+201005144561'}, {'name': 'Mohamed Rashed, Ph.D', 'role': 'CONTACT', 'email': 'mf.helal@nrc.sci.eg'}], 'overallOfficials': [{'name': 'Mariem Elmansy, Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'researcher'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nahda University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Pediatric Dentistry', 'investigatorFullName': 'GHada Abdelwahab Ahmed', 'investigatorAffiliation': 'Nahda University'}}}}