Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 5:30 AM
Study NCT ID:
NCT07426393
Status:
COMPLETED
Last Update Posted:
2026-02-23
First Post:
2026-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparisons of Efficacy of Triphala and Chlorhexidine Mouthwash Against Plaque Accumulation and Gingivitis.
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '220 individuals with chronic generalized gingivitis were recruited from the Outpatient Department of BMU, Dhaka. The current study was designed as a randomized control trial.\n\n* Group A: n = 110 was given Triphala mouthwash\n* Group B: n = 110 was given Chlorhexidine mouthwash'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-15', 'studyFirstSubmitDate': '2026-02-09', 'studyFirstSubmitQcDate': '2026-02-15', 'lastUpdatePostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PIaque Index', 'timeFrame': '30 days', 'description': 'plaque index 0:no plaque is in the area adjacent to the gingiva plaque index 1:there is a plaque in the form of a thin film on the gingival margin plaque index 2:there is a visible plaque in the gingival pocket and gingival margin plaque index 3:there is a dense plaque in the gingival pocket and gingival margin'}, {'measure': 'Gingival Index', 'timeFrame': '30 days', 'description': 'Gingival index 0: Healthy gums. Gingival index 1: Mild discolouration and oedematous gingiva. No bleeding on probing.\n\nGingival index 2: Red, oedematous and shiny gingiva. There is bleeding on probing.\n\nGingival index 3: Red, oedematous and ulcerated gingiva. There is spontaneous bleeding.'}, {'measure': 'BIeeding Index', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gingivitis']}, 'descriptionModule': {'briefSummary': 'Gingivitis is one of the commonly prevalent oral diseases worldwide which is caused by the bacterial biofilm adhering to the teeth surfaces. Chlorhexidine is the antimicrobial agent most familiar to dental professionals. The need for frequent application of Chlorhexidine and other side effects such as unpleasant taste and staining has stimulated the search for alternatives. "Triphala" is among the most common formulas used in Traditional Ayurvedic Medicine. Triphala has an antibacterial effect. In this context, a study was undertaken to ascertain the effects of a mouthwash prepared with Triphala on the oral health status and compare it with commercially available Chlorhexidine mouthwash.', 'detailedDescription': 'Dental plaque is the main cause of gingivitis and effective plaque control is essential for maintaining gingival health. Along with mechanical cleaning methods, mouthwashes are commonly used as adjunct therapy to reduce plaque accumulation and gingival inflammation. Chlorhexidine is considered the gold standard chemical plaque control agent but its long-term use is limited by side effects such as tooth staining and taste alteration. Triphala, a herbal formulation with known antimicrobial and anti-inflammatory properties has emerged as a potential alternative. Comparing the efficacy of triphala and chlorhexidine mouthwash against plaque accumulation and gingivitis may help to identify a safer and acceptable option for maintaining routine oral hygiene.\n\nAims and objectives:\n\nTo compare the efficacy of triphala and chlorhexidine mouth wash against plaque accumulation and gingivitis.\n\nMaterials and methods:\n\nA randomized controlled trial was conducted among 220 patients with chronic generalized gingivitis attending the Outpatient Department of Bangladesh medical University (BMU), Dhaka. Participants were randomly assigned using shuffled numbered cards to Group A (Triphala mouthwash, n = 110) and Group B (Chlorhexidine mouthwash, n = 110).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age groups of 18-45 years with\n* Mild to moderate gingivitis,\n* Patients with a minimum of 20 teeth, and\n* Patients who have not undergone periodontal treatment in the past 6 months.\n\nExclusion Criteria:\n\n* Use of anti-inflammatory drugs and antibiotics in previous 6 months;\n* Individuals with prosthetic appliances or orthodontic appliances that would interfere with evaluation\n* Allergy to Triphala and Chlorhexidine used in the study;\n* Smokers or users of tobacco in any form\n* Lactating females or pregnant women\n* Mental-retarded patients.'}, 'identificationModule': {'nctId': 'NCT07426393', 'briefTitle': 'Comparisons of Efficacy of Triphala and Chlorhexidine Mouthwash Against Plaque Accumulation and Gingivitis.', 'organization': {'class': 'OTHER', 'fullName': 'Bangladesh Medical University'}, 'officialTitle': 'Comparisons of Efficacy of Triphala and Chlorhexidine Mouthwash Against Plaque Accumulation and Gingivitis. A Randomized Controlled Trail.', 'orgStudyIdInfo': {'id': 'BSMMU/2024/6798'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '6% Triphala mouthwash', 'description': 'Experimental: 15ml of 6%Triphala mouthwash twice daily for 30 days.', 'interventionNames': ['Other: 6% Triphala mouthwash']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo Comparator:Placebo Participants received 15 ml of 6% chlorhexidine mouthwash', 'description': 'placebo Participants received 15 ml mouthwash twice daily for 30 days', 'interventionNames': ['Other: .2% chlorhexidine mouthwash']}], 'interventions': [{'name': '6% Triphala mouthwash', 'type': 'OTHER', 'description': 'participants received 15 ml of 6% triphala mouthwash twice daily for 30 days', 'armGroupLabels': ['6% Triphala mouthwash']}, {'name': '.2% chlorhexidine mouthwash', 'type': 'OTHER', 'description': 'participants received 15 ml of .2% chlorhexidine mouthwash twice daily for 30 days', 'armGroupLabels': ['placebo Comparator:Placebo Participants received 15 ml of 6% chlorhexidine mouthwash']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dhaka', 'country': 'Bangladesh', 'facility': 'Bangladesh Medical University', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bangladesh Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Dilruba Sarmin', 'investigatorAffiliation': 'Bangladesh Medical University'}}}}