Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-01 @ 10:48 PM
Study NCT ID:
NCT02154594
Status:
COMPLETED
Last Update Posted:
2014-06-03
First Post:
2014-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"The Efficacy of Acacia Catechu Mouthrinse as Antiplaque and Antigingivitis Agent in Fixed Orthodontic Appliance Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C010882', 'term': 'chlorhexidine gluconate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-30', 'studyFirstSubmitDate': '2014-05-26', 'studyFirstSubmitQcDate': '2014-05-30', 'lastUpdatePostDateStruct': {'date': '2014-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes from baseline in Plaque index(PI)', 'timeFrame': '15 Days'}], 'secondaryOutcomes': [{'measure': 'Changes from baseline in Gingival index(GI)', 'timeFrame': '15 Days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acacia', 'Chlorhexidine', 'Gingivitis', 'Orthodontic appliances.'], 'conditions': ['Gingivitis']}, 'descriptionModule': {'briefSummary': 'To study effect of acacia catechu a herbal extract;as antipaque and antigingivitis agent in patients with fixed orthodontic appliances.This study is a double blind randomized controlled trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 60 patients in the age group of 15-30 yrs\n* plaque induced gingivitis having fixed orthodontic appliance\n\nExclusion Criteria:\n\n* seeking any type of antibacterial mouthwash within four weeks of commencement of study,\n* history of any systemic disease, or past illness,\n* mentally or physically handicapped,\n* history of smoking, tobacco chewing, alcohol consumption,\n* patients with periodontitis, pregnant and lactating women'}, 'identificationModule': {'nctId': 'NCT02154594', 'briefTitle': '"The Efficacy of Acacia Catechu Mouthrinse as Antiplaque and Antigingivitis Agent in Fixed Orthodontic Appliance Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Tatyasaheb Kore Dental College'}, 'orgStudyIdInfo': {'id': 'DHANASHREE289'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acacia', 'description': 'Rinse with 20 ml of Acacia catechu mouthwash twice daily for 15 days', 'interventionNames': ['Drug: Acacia catechu', 'Drug: Chlorhexidine gluconate', 'Other: Distilled water']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chlorhexidine gluconate', 'description': 'Rinse with 10 ml of chlorhexidine mouthwash twice daily for 15 days', 'interventionNames': ['Drug: Acacia catechu', 'Drug: Chlorhexidine gluconate', 'Other: Distilled water']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Distilled water', 'description': 'Rinse with 10 ml distilled water twice daily for 15 days.', 'interventionNames': ['Drug: Acacia catechu', 'Drug: Chlorhexidine gluconate', 'Other: Distilled water']}], 'interventions': [{'name': 'Acacia catechu', 'type': 'DRUG', 'armGroupLabels': ['Acacia', 'Chlorhexidine gluconate', 'Distilled water']}, {'name': 'Chlorhexidine gluconate', 'type': 'DRUG', 'otherNames': ['Hexidine'], 'armGroupLabels': ['Acacia', 'Chlorhexidine gluconate', 'Distilled water']}, {'name': 'Distilled water', 'type': 'OTHER', 'armGroupLabels': ['Acacia', 'Chlorhexidine gluconate', 'Distilled water']}]}, 'contactsLocationsModule': {'locations': [{'zip': '416 137', 'city': 'Kolhāpur', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Tatyasaheb Kore Dental College and Research Centre', 'geoPoint': {'lat': 16.69563, 'lon': 74.23167}}], 'overallOfficials': [{'name': 'Dr.Dhanashree R. Agarwal, B.D.S.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tatyasaheb Kore Dental College and Research Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tatyasaheb Kore Dental College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'POST GRADUATE STUDENT IN PERIODONTOLOGY', 'investigatorFullName': 'DR.DHANASHREE RAVINDRA AGARWAL', 'investigatorAffiliation': 'Tatyasaheb Kore Dental College'}}}}