Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2026-01-01 @ 7:47 AM
Study NCT ID:
NCT02462993
Status:
COMPLETED
Last Update Posted:
2015-06-04
First Post:
2015-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Local Drug Delivery of Aloe Vera Gel in Chronic Periodontitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-03', 'studyFirstSubmitDate': '2015-05-29', 'studyFirstSubmitQcDate': '2015-06-03', 'lastUpdatePostDateStruct': {'date': '2015-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Relative Attachment Loss was taken as the primary outcome', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Change in Probing depth', 'timeFrame': '3 months'}, {'measure': 'Change in number of microbial species', 'timeFrame': '3 months'}]}, 'conditionsModule': {'conditions': ['Periodontitis']}, 'referencesModule': {'references': [{'pmid': '22028505', 'type': 'RESULT', 'citation': "Bhat G, Kudva P, Dodwad V. Aloe vera: Nature's soothing healer to periodontal disease. J Indian Soc Periodontol. 2011 Jul;15(3):205-9. doi: 10.4103/0972-124X.85661."}, {'pmid': '15016256', 'type': 'RESULT', 'citation': "Perinetti G, Paolantonio M, Cordella C, D'Ercole S, Serra E, Piccolomini R. Clinical and microbiological effects of subgingival administration of two active gels on persistent pockets of chronic periodontitis patients. J Clin Periodontol. 2004 Apr;31(4):273-81. doi: 10.1111/j.1600-051x.2004.00481.x."}]}, 'descriptionModule': {'briefSummary': 'Background: Aloe vera is considered to be the most promising and high-ranking agent as an all-purpose herbal plant amongst herbal agents used in dentistry. This study was designed to evaluate the clinical and microbiological effectiveness of locally delivered aloe vera gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.', 'detailedDescription': 'Background: Aloe vera is considered to be the most promising and high-ranking agent as an all-purpose herbal plant amongst herbal agents used in dentistry. This study was designed to evaluate the clinical and microbiological effectiveness of locally delivered aloe vera gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.\n\nMethods: Twelve subjects diagnosed with chronic generalized periodontitis were selected and randomly divided into two groups: Test group which received scaling and root planning (SRP) followed by application of aloe vera gel as a local drug delivery agent in the deepest periodontal pocket and control group which received SRP alone. Clinical evaluation was undertaken using Plaque index (PI), Gingival index (GI), Probing pocket depth (PPD), Relative attachment level (RAL) and Gingival marginal level (GML) and microbiologic counts (total colony count/ml) were assessed at baseline, 6 weeks and 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion in this study was based on the following criteria:\n\n 1. Patients with age group between 30 - 60 years from both sexes.\n 2. Chronic periodontitis patients with at least 1 pair of periodontal pocket ≥ 5mm in contra-lateral quadrants.\n\nExclusion Criteria:\n\n* Exclusion criteria were:\n\n 1. Subjects who have received antibiotic treatment in the preceding 6 months.\n 2. Patients with history of prolonged use of antibiotics/ steroids/ immunosuppressive agents /aspirin/ anticoagulants/ other medications including any herbal products.'}, 'identificationModule': {'nctId': 'NCT02462993', 'briefTitle': 'Local Drug Delivery of Aloe Vera Gel in Chronic Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'Dr. D. Y. Patil Dental College & Hospital'}, 'officialTitle': 'EFFECT OF LOCALLY DELIVERED ALOE VERA GEL AS AN ADJUNCT TO SCALING AND ROOT PLANING IN THE TREATMENT OF CHRONIC PERIODONTITIS: A SPLIT-MOUTH CLINICAL AND MICROBIOLOGICAL STUDY', 'orgStudyIdInfo': {'id': 'DYPCH/12/PG14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aloe vera group', 'description': 'Group recieving scaling and root planing and aloe vera gel local drug delivery', 'interventionNames': ['Drug: Aloe Vera']}, {'type': 'NO_INTERVENTION', 'label': 'SRP group', 'description': 'Group recieving only scaling and root planing'}], 'interventions': [{'name': 'Aloe Vera', 'type': 'DRUG', 'description': 'Local drug delivery of aloe vera gel', 'armGroupLabels': ['Aloe vera group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Krupa H Pathak', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Post graduate'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. D. Y. Patil Dental College & Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Santosh Martande', 'investigatorAffiliation': 'Dr. D. Y. Patil Dental College & Hospital'}}}}