Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 4:38 PM
Study NCT ID:
NCT07356869
Status:
RECRUITING
Last Update Posted:
2026-01-21
First Post:
2026-01-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Probiotic-Based Versus Ethyl Lauroyl Arginate-Containing Mouthwashes on Streptococcus Mutans Counts, Dental Plaque Accumulation, and Salivary pH in a Group of Egyptian School Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003773', 'term': 'Dental Plaque'}], 'ancestors': [{'id': 'D003741', 'term': 'Dental Deposits'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014080', 'term': 'Tooth Exfoliation'}], 'ancestors': [{'id': 'D009063', 'term': 'Dental Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-13', 'studyFirstSubmitDate': '2026-01-13', 'studyFirstSubmitQcDate': '2026-01-13', 'lastUpdatePostDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'S. mutans count', 'timeFrame': '28 days post-intervention', 'description': 'S. mutans count will be measured at baseline (0 day) and post-intervention (28 days).'}], 'secondaryOutcomes': [{'measure': 'Plaque index score', 'timeFrame': '28 days post-intervention', 'description': 'The plaque index score is classified as:\n\n* Score 0; No plaque\n* Score 1; Mild plaque accumulated along the gingival margin\n* Score 2; Moderate plaques accumulated along the gingival margin\n* Score 3; Heavy plaques accumulated along the gingival margin and adjacent tooth surface.\n\nPlaque index score will be measured at baseline (0 day) and post-intervention (28 days).'}, {'measure': 'Salivary pH', 'timeFrame': '28 days post-intervention', 'description': 'Salivary pH measurements will be carried out by pH strips or pH meter.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Probiotic', 'Ethyl Lauroyl Arginate', 'Mouthwashes', 'Streptococcus Mutans', 'Dental Plaque', 'Salivary pH', 'Children']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the efficacy of probiotic-based mouthwashes versus ethyl lauroyl arginate-containing mouthwashes in reducing Streptococcus mutans count, dental plaque accumulation, and salivary pH among a group of Egyptian schoolchildren.', 'detailedDescription': 'Dental caries remains one of the most prevalent chronic infectious diseases among Egyptian schoolchildren, with Streptococcus mutans (S. mutans) playing a primary etiological role due to its acidogenic and aciduric properties, which contribute to enamel demineralization and plaque formation.\n\nEthyl Lauroyl Arginate (LAE), a cationic surfactant derived from lauric acid and arginine, has demonstrated potent bactericidal activity against cariogenic organisms, including S. mutans, while also reducing biofilm formation and preserving oral microbiome balance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Egyptian schoolchildren aged 6-12 years.\n* Good general health.\n* Mild to moderate dental plaque accumulation.\n* Parental/caregiver willingness to provide consent\n\nExclusion Criteria:\n\n* Antibiotic or antimicrobial use within the last month.\n* Allergies to the mouthwash components.\n* Systemic diseases affecting oral health.\n* Orthodontic appliances or extensive dental restorations.'}, 'identificationModule': {'nctId': 'NCT07356869', 'briefTitle': 'Probiotic-Based Versus Ethyl Lauroyl Arginate-Containing Mouthwashes on Streptococcus Mutans Counts, Dental Plaque Accumulation, and Salivary pH in a Group of Egyptian School Children', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Comparative Evaluation of Probiotic-Based Versus Ethyl Lauroyl Arginate-Containing Mouthwashes on Streptococcus Mutans Counts, Dental Plaque Accumulation, and Salivary pH in a Group of Egyptian School Children: A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '1246/4697'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Patients will be receive probiotic mouthwash and instructed to rinse 5ml twice daily for 30 seconds for 28 days.', 'interventionNames': ['Other: Probiotic mouthwash']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Patients will be treated with ethyl lauroyl arginate-containing mouthwash and instructed to rinse 5ml twice daily for 30 seconds for 28 days.', 'interventionNames': ['Other: Ethyl lauroyl arginate mouthwash']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C', 'description': 'Patients will receive professional prophylaxis (scaling + polishing) at baseline and will use only regular toothpaste twice daily, with no adjunctive mouthwashes over 28 days.', 'interventionNames': ['Other: Professional prophylaxis (scaling + polishing)']}], 'interventions': [{'name': 'Probiotic mouthwash', 'type': 'OTHER', 'description': 'Patients will be receive probiotic mouthwash and instructed to rinse 5ml twice daily for 30 seconds for 28 days.', 'armGroupLabels': ['Group A']}, {'name': 'Ethyl lauroyl arginate mouthwash', 'type': 'OTHER', 'description': 'Patients will be treated with ethyl lauroyl arginate mouthwash and instructed to rinse 5ml twice daily for 30 seconds for 28 days.', 'armGroupLabels': ['Group B']}, {'name': 'Professional prophylaxis (scaling + polishing)', 'type': 'OTHER', 'description': 'Patients will receive professional prophylaxis (scaling + polishing) at baseline and will use only regular toothpaste twice daily, with no adjunctive mouthwashes over 28 days.', 'armGroupLabels': ['Group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11651', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed O Abdelrazik, MBBCH', 'role': 'CONTACT', 'email': 'mohamedghitany96@gmail.com', 'phone': '00201017005990'}, {'name': 'Adel F Hussein, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ramy S Khairallah, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alsayed E Mekky, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Al-Azhar University (Faculty of Dentistry)', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mohamed O Abdelrazik, MBBCH', 'role': 'CONTACT', 'email': 'mohamedghitany96@gmail.com', 'phone': '00201017005990'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'B.D.S, Faculty of Dental Medicine (Cairo-Boys), Al-Azhar University', 'investigatorFullName': 'Mohamed Osama Mohamed Abdelrazik', 'investigatorAffiliation': 'Al-Azhar University'}}}}