Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-01-03 @ 10:41 AM
Study NCT ID:
NCT06538532
Status:
COMPLETED
Last Update Posted:
2024-08-27
First Post:
2024-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anticariogenic Properties of Zamzam Water
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-25', 'studyFirstSubmitDate': '2024-07-25', 'studyFirstSubmitQcDate': '2024-08-02', 'lastUpdatePostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Streptomutans count', 'timeFrame': '3 months and 6 months', 'description': 'measurements of Colony forming unit (CFU) will be performed using blood agar and mitis salivarius-bacitracin agar (MSBA).'}, {'measure': 'Salivary PH level', 'timeFrame': '3 months and 6 months', 'description': 'using pH meter'}, {'measure': 'caries risk level', 'timeFrame': '3 months and 6 months', 'description': 'According to ADA'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Caries,Dental', 'Caries Active']}, 'descriptionModule': {'briefSummary': 'The present study aims to evaluate and compare the effect of Zamzam water as mouthwashes in high caries-risk patients regarding:\n\ni. Streptococcus mutans (S. mutans) count. ii. Oral pH. After 3 and 6 months interval.', 'detailedDescription': 'The present study aims to evaluate and compare the effect of Zamzam water mouthwashes in high caries-risk patients regarding:\n\ni. Streptococcus mutans (S. mutans) count. ii. Oral pH. all patients will be into two groups; The first group will use Zamzam water mouthwash for a six months with other preventive protocols including fissure sealants and preventive restorations wherever needed, while the second group will undergo preventive protocols only. During these six months, patients will be reassessed at three and six-month intervals regarding S. mutans count, oral pH, and caries risk level.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female participants aged between 18-35 years.\n* Systemically- free individuals.\n* High caries-risk patients according to ADA (American Dental Association).\n* Not on a medication interfering with salivary secretion.\n* Co-operative patients approved to participate in the study.\n\nExclusion Criteria:\n\n* Patients who are already on any mouthwash regime.\n* Patients who are on any medication that would alter the salivary secretion.\n* Allergy to any of the ingredients of the study products.'}, 'identificationModule': {'nctId': 'NCT06538532', 'briefTitle': 'Anticariogenic Properties of Zamzam Water', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Effect of Zamzam Water on Streptococcus Mutans and Oral pH in High Caries-Risk Patients', 'orgStudyIdInfo': {'id': 'P-OP-24-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '(A1) Zamzam water mouthwash', 'interventionNames': ['Other: Zamzam water']}, {'type': 'NO_INTERVENTION', 'label': '(A2) Control group: will be on tooth brushing only'}], 'interventions': [{'name': 'Zamzam water', 'type': 'OTHER', 'description': 'Zamzam water', 'armGroupLabels': ['(A1) Zamzam water mouthwash']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4434103', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Dental medicine for Girls Al Azhar university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Reham Youssef', 'investigatorAffiliation': 'Al-Azhar University'}}}}