Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2025-12-25 @ 2:02 PM
Study NCT ID:
NCT04484792
Status:
COMPLETED
Last Update Posted:
2020-07-24
First Post:
2020-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Green Tea Mouthwash on Generalized Plaque- Induced Gingivitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-22', 'studyFirstSubmitDate': '2020-07-21', 'studyFirstSubmitQcDate': '2020-07-22', 'lastUpdatePostDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'plaque control record', 'timeFrame': 'over 27 days'}, {'measure': 'gingival bleeding index', 'timeFrame': 'over 27 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Plaque Induced Gingivitis']}, 'descriptionModule': {'briefSummary': 'This investigation will study the effect of green tea mouthwash as an adjunctive therapy to mechanical treatment on gingival health, and whether it has any side effects. This study also aims at increasing the awareness among health professionals and the community regarding the benefits of natural herbal products such as green tea on oral health, opposed to common chemical products. This may provide an efficient alternative for people who are sensitive to certain chemical products or who have limited sources of income and cannot afford expensive treatment of dental problems.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients attending the clinics at the Taibah University Dental College and Hospital (TUDCH)\n* Age from 18 - 35 years\n* Generalized plaque-induced gingivitis (GBI \\> 85%)\n\nExclusion Criteria:\n\n* Patients with any systemic diseases\n* Patients under regular medication (e.g. Contraceptives, Hormone- Replacement Therapy)\n* Pregnant or breast-feeding patients\n* Smokers\n* Periodontitis patients\n* Patients who received any form of periodontal therapy within the last 6 months\n* Patients who were under antibiotic therapy the past month\n* Patients using regular mouthwash or other chemical plaque control agents (e.g. Miswak) except for regular toothpaste (Note: toothpastes with specific anti-inflammatory properties are excluded)'}, 'identificationModule': {'nctId': 'NCT04484792', 'briefTitle': 'Green Tea Mouthwash on Generalized Plaque- Induced Gingivitis', 'organization': {'class': 'OTHER', 'fullName': 'Taibah University'}, 'officialTitle': 'Green Tea Mouthwash on Generalized Plaque- Induced Gingivitis: A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'TUCDREC/20181112/AlRehaili'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'interventionNames': ['Other: green tea mouthwash']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'interventionNames': ['Other: green tea mouthwash']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group C', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'green tea mouthwash', 'type': 'OTHER', 'description': 'green tea bags in 100 ml warm water for 5 min', 'armGroupLabels': ['Group A']}, {'name': 'green tea mouthwash', 'type': 'OTHER', 'description': ', in Group B its prepared by soaking tea bags in 100 ml hot water followed by ice addition.', 'armGroupLabels': ['Group B']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'Plain water', 'armGroupLabels': ['Group C']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Madīnah', 'country': 'Saudi Arabia', 'facility': 'Taibah University', 'geoPoint': {'lat': 24.74934, 'lon': 46.63439}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taibah University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alhanouf M. AlRehaili', 'investigatorAffiliation': 'Taibah University'}}}}