Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-02-25 @ 9:39 PM
Study NCT ID:
NCT03773094
Status:
UNKNOWN
Last Update Posted:
2018-12-12
First Post:
2018-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antibacterial Effect of Guava Leaves Extract Mouthwash Compared to Chlorhexidine Mouthwash in High Caries Risk Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 94}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-11', 'studyFirstSubmitDate': '2018-12-08', 'studyFirstSubmitQcDate': '2018-12-11', 'lastUpdatePostDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient satisfaction to taste: questionnaire', 'timeFrame': '3 months', 'description': 'The patient will fill a questionnaire to assess patient satisfaction to taste after usage of the mouthwash. Nominal answers'}], 'primaryOutcomes': [{'measure': 'Anti-bacterial effect against streptococcus mutans', 'timeFrame': '3 months', 'description': 'Antimicrobial effect against streptococcus mutans: saliva samples collected and total bacterial count measured after agar plates incubating, expressed in colony forming units'}], 'secondaryOutcomes': [{'measure': 'Salivary pH', 'timeFrame': '3 months', 'description': 'Saliva samples pH will be measured using digital pH meter to evaluate its efficacy in preventing the action of acidogenic bacteria in high caries risk patients.\n\nIt displays numerical value.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['High Caries Risk Patients', 'Antimicrobial Effect', 'Salivary pH', 'Patient Satisfaction to Taste']}, 'referencesModule': {'references': [{'pmid': '26130940', 'type': 'BACKGROUND', 'citation': 'Gupta D, Nayan S, Tippanawar HK, Patil GI, Jain A, Momin RK, Gupta RK. Are herbal mouthwash efficacious over chlorhexidine on the dental plaque? Pharmacognosy Res. 2015 Jul-Sep;7(3):277-81. doi: 10.4103/0974-8490.155874.'}, {'pmid': '25125881', 'type': 'BACKGROUND', 'citation': 'Ravi K, Divyashree P. Psidium guajava: A review on its potential as an adjunct in treating periodontal disease. Pharmacogn Rev. 2014 Jul;8(16):96-100. doi: 10.4103/0973-7847.134233.'}, {'pmid': '29087796', 'type': 'BACKGROUND', 'citation': 'Singla S, Malhotra R, Nd S, Saxena S. Antibacterial Efficacy of Mouthwash Prepared from Pomegranate, Grape Seed and Guava Extracts against Oral Streptococci: An in Vivo Study. J Clin Pediatr Dent. 2018;42(2):109-113. doi: 10.17796/1053-4628-42.2.5. Epub 2017 Oct 31.'}, {'pmid': '30166841', 'type': 'BACKGROUND', 'citation': 'Shah S, Bargale S, Dave BH, Deshpande A, Kariya PB, Karri A. Comparison of Antimicrobial Efficacy of (between) 0.2% Chlorhexidine and Herbal Mouthwash on Salivary Streptococcus mutans: A Randomized Controlled Pilot Study. Contemp Clin Dent. 2018 Jul-Sep;9(3):440-445. doi: 10.4103/ccd.ccd_264_18.'}, {'pmid': '27681394', 'type': 'BACKGROUND', 'citation': 'Jain I, Jain P. Comparative evaluation of antimicrobial efficacy of three different formulations of mouth rinses with multi-herbal mouth rinse. J Indian Soc Pedod Prev Dent. 2016 Oct-Dec;34(4):315-23. doi: 10.4103/0970-4388.191409.'}]}, 'descriptionModule': {'briefSummary': 'This trial is to test the antibacterial effect of Guava leaves extract mouth wash compared to Chlorhexidine mouth wash in high caries risk patients.\n\nAlso salivary pH and patient satisfaction to taste will also be tested.', 'detailedDescription': 'This study is conducted to evaluate the effect of Guava leaves extract mouth wash on anti-bacterial activity against streptococcus mutans, salivary pH and patient satisfaction to taste compared to Chlorhexidine mouth wash.\n\nP: Population with high caries risk patients I: Intervention by Guava leaves extract mouthwash C: Control is Chlorhexidine mouthwash O1: The primary outcome is antibacterial activity. O2: The secondary outcome is salivary pH O3: The tertiary outcome is patient satisfaction to taste'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. High caries risk patients\n2. 18-50 years\n3. Healthy cooperative patients\n4. Males or Females\n\nExclusion Criteria\n\n1. Medically compromised patients\n2. Patients with any systemic disease that might affect the salivary flow\n3. Allergy to any of the ingredients\n4. Patients with physical limitations that might affect normal tooth brushing and mouth rinsing\n5. Presence of intraoral infections\n6. Currently using any mouth rinse\n7. Smokers\n8. Use of antibiotics in the previous 30 days'}, 'identificationModule': {'nctId': 'NCT03773094', 'briefTitle': 'Antibacterial Effect of Guava Leaves Extract Mouthwash Compared to Chlorhexidine Mouthwash in High Caries Risk Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Guava Leaves Extract Mouth Wash on Antibacterial Activity, Salivary pH and Patient Satisfaction Compared to Chlorhexidine Mouth Wash in High Caries Risk Patients: A Randomized Control Clinical Trial', 'orgStudyIdInfo': {'id': 'Guava leaves extract CHX'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Guava leaves extract', 'description': 'A natural product that is prepared as a mouthwash', 'interventionNames': ['Drug: Guava leaves extract']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chlorhexidine', 'description': 'chemical agent Chlorhexidine as a mouthwash', 'interventionNames': ['Drug: Chlorhexidine']}], 'interventions': [{'name': 'Guava leaves extract', 'type': 'DRUG', 'otherNames': ['Psidium guajava'], 'description': 'Natural product : The leaves of the guava tree are full of antioxidants, anti-inflammatory agents, antibacterials, and even tannins that can have significant health benefits, from treating stomach troubles to chronic diseases like cancer\n\n•', 'armGroupLabels': ['Guava leaves extract']}, {'name': 'Chlorhexidine', 'type': 'DRUG', 'otherNames': ['Chlorhexidine glucnate'], 'description': 'chemical agent used as a mouthwash against cariogenic bacteria. considered the gold standard', 'armGroupLabels': ['Chlorhexidine']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': "Engy MM Kassem, Master's degree", 'role': 'CONTACT', 'email': 'engy.mostafa@dentistry.cu.edu.eg', 'phone': '00201000687726'}, {'name': 'Mohamed A Khairy, PhD', 'role': 'CONTACT', 'email': 'madelkhairy@dentistry.cu.edu.eg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'Engy Mostafa Magdy Abdou Ahmed Kassem', 'investigatorAffiliation': 'Cairo University'}}}}