Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2026-03-04 @ 10:29 AM
Study NCT ID:
NCT03115892
Status:
UNKNOWN
Last Update Posted:
2017-04-27
First Post:
2017-04-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Green Tea With Aloe Vera Mouthwash and Chlorohexidine Mouthwash
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006209', 'term': 'Halitosis'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013662', 'term': 'Tea'}], 'ancestors': [{'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Statistician only will be blind'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'two group one for intervention and one for control randomize control trail'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 27}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-26', 'studyFirstSubmitDate': '2017-04-12', 'studyFirstSubmitQcDate': '2017-04-13', 'lastUpdatePostDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oral malodor', 'timeFrame': 'one week', 'description': 'Smell identification test (organoleptic ) (human nose)'}], 'secondaryOutcomes': [{'measure': 'Streptococcal count', 'timeFrame': 'one week', 'description': 'measuring Tool by using blood agar plate unit CFU/ml colony-forming units'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Halitosis']}, 'referencesModule': {'references': [{'pmid': '23489103', 'type': 'RESULT', 'citation': 'Dadamio J, Van Tournout M, Teughels W, Dekeyser C, Coucke W, Quirynen M. Efficacy of different mouthrinse formulations in reducing oral malodour: a randomized clinical trial. J Clin Periodontol. 2013 May;40(5):505-13. doi: 10.1111/jcpe.12090. Epub 2013 Mar 13.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/23489103?tool=bestpractice.bmj.com', 'label': 'paper'}]}, 'descriptionModule': {'briefSummary': 'The Effect of Mouthwash Containing Green Tea With Aloe Vera and Chlorhexidine Mouthwash on Oral Malodour Among a Group of Egyptian Children: Randomized Clinical Trial', 'detailedDescription': '1\\. Diagnosis:\n\n1. Diagnostic chart (Appendix A) will be filled with personal, medical and dental history. DMF and def caries index (decayed, missing, and filled teeth).\n2. The intra oral and extra oral examinations will be made using masks, gloves, cap, goggles, gauze, medical tray, dental mirror and WHO ( World Health Organization ) probe. All materials will be packaged in sterilizations wraps and autoclave, following the required bio safety standards\n\n2\\. Intervention:\n\n• The participants included will be allocated into two groups by drawing of sealed and opaque envelopes containing the codes "A" and "B".\n\nExperimental Group:( intervention ) Green tea with Aloe- Vera\n\n1. Preparation of green tea with aloe - Vera will occur under aseptic condition by pharmacist (Sargolzaie et al, 2015).\n2. Collection of saliva samples (pre-rinse) will be obtained from children who fulfilled the inclusion criteria.\n3. Distinguish odors using the Smell identification test (Doty et al. 1984). Breath was scored as described by Rosenberg at rest (open mouth without breathing) and when the patients counted from 1 to 11 (Rosenberg, 1996). A 0-5 score was given (Green man et al. 2004).\n4. Subjects will be instructed to wash and retain the respective mouth rinse in the mouth for 40 Seconds before expectorating it.\n5. 15 min after a rinse , Breath was scored as described by Rosenberg at rest (open mouth without breathing) and when the patients counted from 1 to 11 (Rosenberg, 1996). A 0-5 score was given (Green man et al. 2004). (masking effect)\n6. Patients will not allow consuming any diet or drinking orally for following 90 min.\n7. Again after 90 min, the saliva samples will be taken and inoculated on blood agar plates to determine the colony count (Velmurugan et al, 2013) and\n8. Patients with confirmed oral malodor rinsed mouthwash during 7 days (15 ml, 2x/day for 1 min.)\n9. After 7 days Breath was scored as described by Rosenberg at rest (open mouth without breathing) and when the patients counted from 1 to 11 (Rosenberg, 1996). A 0-5 score was given (Green man et al. 2004). (therapeutic effect).\n\nComparative Group:\n\nCommercial Chlorhexidine 0.2%\n\n1. Collection of saliva samples (pre-rinse) will be obtained from children who fulfilled the inclusion criteria.\n2. Distinguish odors using the Smell identification test (Doty et al. 1984). Breath was scored as described by Rosenberg at rest (open mouth without breathing) and when the patients counted from 1 to 11 (Rosenberg, 1996). A 0-5 score was given (Green man et al. 2004).\n3. Subjects will be instructed to wash and retain the respective mouth rinse in the mouth for 40 Seconds before expectorating it.\n4. 15 min after a rinse , Breath was scored as described by Rosenberg at rest (open mouth without breathing) and when the patients counted from 1 to 11 (Rosenberg, 1996). A 0-5 score was given (Green man et al. 2004). (masking effect)\n5. Patients will not allow consuming any diet or drinking orally for following 90 mins.\n6. Again after 90 min, the saliva samples will be taken and inoculated on blood agar plates to determine the colony count (Velmurugan et al, 2013) .\n7. Patients with confirmed oral malodor rinsed mouthwash during 7 days (15 ml, 2x/day for 1 min.)\n8. After 7 days Breath was scored as described by Rosenberg at rest (open mouth without breathing) and when the patients counted from 1 to 11 (Rosenberg, 1996). A 0-5 score was given (Green man et al. 2004). (therapeutic effect).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Children aged between 6 and 12 years. 2. Children having normal occlusion, non-compromised oral health (brushed their teeth once-daily) using toothbrush and non-fluoridated toothpaste. And practicing no other oral hygiene measures.\n\nExclusion Criteria:\n\n* 1\\. History of current or recent (at least for the past 1 month) antibiotic usage or other medications.\n\n 2\\. Abscess, draining sinus, cellulitis, or other conditions requiring emergency dental treatment.\n\n 3\\. Children with known history of allergy to any mouthrinse or drug. 4. Children who wore fixed or removable orthodontic appliances.'}, 'identificationModule': {'nctId': 'NCT03115892', 'acronym': 'RCT', 'briefTitle': 'Green Tea With Aloe Vera Mouthwash and Chlorohexidine Mouthwash', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'The Effect of Mouthwash Containing Green Tea With Aloe Vera and Chlorhexidine Mouthwash on Oral Malodour Among a Group of Egyptian Children: Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'pedodontics'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention arm', 'description': 'Green Tea With Aloe Vera mouthwash twice daily for one week', 'interventionNames': ['Drug: Green Tea With Aloe Vera mouthwash']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control arm', 'description': 'Chlorhexidine Mouthwash twice daily for one week', 'interventionNames': ['Drug: Chlorhexidine mouthwash']}], 'interventions': [{'name': 'Green Tea With Aloe Vera mouthwash', 'type': 'DRUG', 'otherNames': ['herbal mouthwash'], 'description': 'measuring Tool/device Smell identification test ( organoleptic score ) (human nose) to measure of malodor which its unit 0-5 score', 'armGroupLabels': ['intervention arm']}, {'name': 'Chlorhexidine mouthwash', 'type': 'DRUG', 'otherNames': ['Chemical mouthwash'], 'description': 'chlorohexidine mouthwash take two times per day for one week', 'armGroupLabels': ['control arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Oral An Dental Medicine Faculty', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'sherif B eltweel, ass.prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'cairo unversity'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'it will be available after finished'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'oral and dental medicine , principle investigator', 'investigatorFullName': 'Asmaa Salah Eldin Abd El Samea Allam', 'investigatorAffiliation': 'Cairo University'}}}}