Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-01-04 @ 8:52 PM
Study NCT ID:
NCT01956656
Status:
UNKNOWN
Last Update Posted:
2013-12-11
First Post:
2013-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Of Lotus Leaves In Management Of Plaque Induced Gingivitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2014-07-14', 'releaseDate': '2014-06-14'}], 'estimatedResultsFirstSubmitDate': '2014-06-14'}}, '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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-12-10', 'studyFirstSubmitDate': '2013-09-17', 'studyFirstSubmitQcDate': '2013-10-07', 'lastUpdatePostDateStruct': {'date': '2013-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plaque induced gingivitis', 'timeFrame': '4 days', 'description': 'Gingivitis is measured using, Sillness\\&Loe(1964):Plaque Index Gingival index(GI)-Loe\\&Sillness(1963) before and after dispensing of mouthwash.'}], 'secondaryOutcomes': [{'measure': 'Grams Staining of the plaque collected from the subjects', 'timeFrame': '4 days', 'description': 'Supra-gingival plaque sample are taken microbiological(gram staining)analysis before and after mouthwash dispensing.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['lotus leaf, mouthwash, gingivitis'], 'conditions': ['Gingivitis']}, 'descriptionModule': {'briefSummary': 'Due to difficulties in maintenance of an effective mechanical oral hygiene regime, effective chemical adjunctive measures will likely significantly contribute to overall oral health, the function of which should be to augment mechanical plaque control. Traditionally, in Chinese medicine the lotus leaf has been used for treating gingival inflammation. An extract of lotus leaves have demonstrated significant antibacterial activity against some of the periodontopathogens.', 'detailedDescription': 'The objective of the present research is to evaluate the efficacy of a lotus leaf mouth wash in management of plaque induced gingivitis.\n\nStudy design: 30 systemically healthy volunteers will be randomly allocated into two arms\n\nArm A: Lotus leaf mouth wash (aqueous) group \\[Test group\\] Arm B: Placebo mouth wash group \\[Control group\\]\n\nAll the volunteers are instructed to refrain from tooth brushing 24 hours before the examination. Clinical parameters (plaque index, bleeding index and gingival index)will be measured and the plaque samples are collected from subjects from each group for microbiological analysis. All the participants will undergo scaling, and they were instructed to refrain from tooth cleaning procedures and were advised to use the prescribed mouth wash twice daily for 4 days. All volunteers were recalled on 5th day for clinical and microbiological analysis. Statistical analysis and results are awaited'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects willing to comply with the study protocol \\& instruction.\n2. Clinically diagnosed with chronic gingivitis.\n3. No history of allergies to herbal formulations.\n4. No history of periodontal therapy within the previous 6 months.\n5. No history of antibiotic therapy within the previous 6 months.\n\nExclusion Criteria:\n\n1. Any systemic diseases\n2. Use of tobacco or tobacco related products\n3. Pregnant woman and lactating mothers\n4. Subjects that had used any type of antibacterial mouthrinse within 4 weeks of recruitment in to the study.'}, 'identificationModule': {'nctId': 'NCT01956656', 'briefTitle': 'Efficacy Of Lotus Leaves In Management Of Plaque Induced Gingivitis', 'organization': {'class': 'OTHER', 'fullName': 'Sri Hasanamba Dental College and Hospital'}, 'officialTitle': 'Efficacy Of Lotus Leaves In Management Of Plaque Induced Gingivitis: A 4 Day Double Blind Clinico-Microbiological Trial.', 'orgStudyIdInfo': {'id': 'z59p5gy7'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'lotus leaf mouthwash', 'description': '10 ml mouthwash to be used for 4days twice daily', 'interventionNames': ['Drug: lotus leaf mouthwash']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo mouthwash', 'description': '10 ml mouthwash to be used for 4 days twice daily'}], 'interventions': [{'name': 'lotus leaf mouthwash', 'type': 'DRUG', 'otherNames': ['Lotus mouthwash'], 'description': 'Saline mouthwash to be used for 4 days twice daily by one group the other group the lotus leaf mouthwash', 'armGroupLabels': ['lotus leaf mouthwash']}]}, 'contactsLocationsModule': {'locations': [{'zip': '573202', 'city': 'Hassan', 'state': 'Karnataka', 'country': 'India', 'facility': 'Sri Hasanamba Dental College and Hospital', 'geoPoint': {'lat': 13.00715, 'lon': 76.0962}}], 'overallOfficials': [{'name': 'Dr Ravindra Shivamurthy, MDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sri Hasanamba Dental College and Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sri Hasanamba Dental College and Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'P.G. student', 'investigatorFullName': 'Dr.Gopi Kishore.C.R.', 'investigatorAffiliation': 'Sri Hasanamba Dental College and Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2014-06-14', 'type': 'RELEASE'}, {'date': '2014-07-14', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Dr.Gopi Kishore.C.R., P.G. student, Sri Hasanamba Dental College and Hospital'}}}}