Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 11:02 AM
Study NCT ID:
NCT07401069
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-10
First Post:
2026-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Homemade Herbal Mouthwash in Gingivitis. A Randomized Clinical Trial.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005891', 'term': 'Gingivitis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-06', 'studyFirstSubmitDate': '2026-02-01', 'studyFirstSubmitQcDate': '2026-02-06', 'lastUpdatePostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "plaque index (O'Leary et al., 1972)", 'timeFrame': '7 days', 'description': 'Plaque accumulation is tested on teeth with a probe. Number of sites having plaque accumulation will be divided by the total number of dental sites to get percentage of plaque accumulation.'}], 'secondaryOutcomes': [{'measure': 'Bleeding on probing', 'timeFrame': '7 days', 'description': 'Bleeding on probing is tested on teeth with a periodontal probe. Number of sites showing bleeding will be divided by the total number of dental sites to get percentage of bleeding on probing.'}, {'measure': 'Changes in clinical signs of inflammation (Armitage, 2004)', 'timeFrame': '7 days', 'description': 'Results will be in the form of (Yes/No); indicating if the gingival clinical condition (color and contour) was improved or not'}, {'measure': 'Bleeding on brushing', 'timeFrame': '7 days', 'description': 'Evaluation of extent of daily bleeding on brushing using VAS.'}, {'measure': "Patient's acceptance of the mouthwash", 'timeFrame': '7 days', 'description': 'questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gingivitis']}, 'descriptionModule': {'briefSummary': 'Gingivitis is a very common oral disease that may progress to the more destructive periodontitis if not treated. As oral plaque is a key player in gingivitis, plaque control by professional scaling and oral hygiene measures represents the main line of treatment.\n\nAmong the oral hygiene measures, using chlorhexidine mouthwash is considered the gold standard in mouthwashes. However, due to its side effects, a safer and more acceptable mouthwash is needed. Therefore, this study proposes mouthwashes made of infusion of natural herbs as an alternative.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Plaque-induced gingivitis.\n\nExclusion Criteria:\n\n* Medically compromised.\n* History of medications.\n* Pregnant females.\n* Periapical involvement in teeth.\n* History of periodontal surgery.\n* If gingivitis was due to local factor.'}, 'identificationModule': {'nctId': 'NCT07401069', 'briefTitle': 'Homemade Herbal Mouthwash in Gingivitis. A Randomized Clinical Trial.', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'The Effect of Homemade Herbal Mouthwash Versus Chlorhexidine on Plaque Accumulation in Gingivitis. A Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'ACU-Per3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Chlorhexidine mouthwash', 'interventionNames': ['Drug: Chlorhexidine 0,12%']}, {'type': 'EXPERIMENTAL', 'label': 'Herbal Homemade Mouthwash', 'interventionNames': ['Drug: herbal Mouthwash']}], 'interventions': [{'name': 'Chlorhexidine 0,12%', 'type': 'DRUG', 'description': 'chlorhexidine 0.12% mouthwash twice daily for 7 days', 'armGroupLabels': ['Chlorhexidine mouthwash']}, {'name': 'herbal Mouthwash', 'type': 'DRUG', 'description': 'Mouthwash made at home by boiling herbs in water and then saving the solution in a tightly closed container for daily use for 7 days', 'armGroupLabels': ['Herbal Homemade Mouthwash']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Ayat Gamal-AbdelNaser', 'investigatorAffiliation': 'Cairo University'}}}}