Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2026-01-08 @ 7:35 PM
Study NCT ID:
NCT02800902
Status:
COMPLETED
Last Update Posted:
2016-06-15
First Post:
2016-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Locally Delivered Atorvastatin & Rosuvastatin for Treatment of Furcation Defects in Chronic Periodontitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055113', 'term': 'Chronic Periodontitis'}], 'ancestors': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}, {'id': 'D000069059', 'term': 'Atorvastatin'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-14', 'studyFirstSubmitDate': '2016-06-07', 'studyFirstSubmitQcDate': '2016-06-14', 'lastUpdatePostDateStruct': {'date': '2016-06-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Bone defect fill', 'timeFrame': 'baseline, 6 & 9 months', 'description': 'Assessed in percentage'}], 'secondaryOutcomes': [{'measure': 'Change in modified sulcus bleeding index', 'timeFrame': 'baseline, 6 & 9 months', 'description': 'scale 0-3'}, {'measure': 'Change in Plaque index', 'timeFrame': 'baseline, 6 & 9 months', 'description': 'scale 0-3'}, {'measure': 'Change in pocket probing depth', 'timeFrame': 'baseline, 6 & 9 months', 'description': 'measured in mm'}, {'measure': 'Change in relative vertical clinical attachment level', 'timeFrame': 'baseline, 6 & 9 months', 'description': 'measured in mm'}, {'measure': 'Change in relative horizontal clinical attachment level', 'timeFrame': 'baseline, 6 & 9 months', 'description': 'measured in mm'}]}, 'conditionsModule': {'conditions': ['Chronic Periodontitis']}, 'referencesModule': {'references': [{'pmid': '27715376', 'type': 'DERIVED', 'citation': 'Garg S, Pradeep AR. 1.2% Rosuvastatin and 1.2% Atorvastatin Gel Local Drug Delivery and Redelivery in the Treatment of Class II Furcation Defects: A Randomized Controlled Clinical Trial. J Periodontol. 2017 Mar;88(3):259-265. doi: 10.1902/jop.2016.160399. Epub 2016 Oct 7.'}]}, 'descriptionModule': {'briefSummary': 'Statins are one of the lipid lowering drugs that help in reducing cholesterol levels in the body by specifically inhibiting 3-hydroxy-3-methylglutaryl coenzyme A reductase; which is a rate limiting enzyme for cholesterol synthesis. Rosuvastatin (RSV) and atorvastatin (ATV) have shown to have bone stimulatory and anti-inflammatory effects.. The present study aims to explore the efficacy of 1.2% RSV and 1.2% ATV gel as a local drug delivery and redelivery system as an adjunct to scaling and root planing (SRP) for the treatment of degree II furcation defects.', 'detailedDescription': 'Statins are one of the lipid lowering drugs that help in reducing cholesterol levels in the body by specifically inhibiting 3-hydroxy-3-methylglutaryl coenzyme A reductase; which is a rate limiting enzyme for cholesterol synthesis. Rosuvastatin (RSV) and atorvastatin (ATV) have shown to have bone stimulatory and anti-inflammatory effects.. The present study aims to explore the efficacy of 1.2% RSV and 1.2% ATV gel as a local drug delivery and redelivery system as an adjunct to scaling and root planing (SRP) for the treatment of degree II furcation defects.\n\nMethods: Ninety patients with mandibular buccal class II furcation defects were randomly allocated into three treatment groups: SRP plus placebo gel (group 1), SRP plus 1.2% RSV gel (group 2) and 1.2% ATV gel (group3). Clinical and radiographic parameters were recorded at baseline then after 6 months. The gels were redelivered at the respective sites at this 6 month appointment. Then again all clinical and radiographic parameters were recorded after 3 months. (9 months from baseline)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Systemically healthy patients with mandibular class II furcation defects and asymptomatic endodontically vital mandibular molars with radiolucency in furcation area with PD ≥ 5mm and horizontal PD ≥ 3mm and with no history of antibiotic or any periodontal therapy in past 6 months were included in the study\n\nExclusion Criteria:\n\n* Subjects with any known systemic disease, allergic to statins, on systemic statin therapy, alcoholics, tobacco users, pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT02800902', 'briefTitle': 'Locally Delivered Atorvastatin & Rosuvastatin for Treatment of Furcation Defects in Chronic Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'Government Dental College and Research Institute, Bangalore'}, 'officialTitle': 'Comparative Evaluation of Locally Delivered 1.2% Atorvastatin and 1.2% Rosuvastatin Gel in Treatment of Mandibular Degree ii Furcation Defects in Chronic Periodontitis Subjects: A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'GDCRI/ACM/PG/PhD/2/2014-2015U8'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'group 1', 'description': 'Scaling and root planing (SRP) followed by placebo gel local drug delivery', 'interventionNames': ['Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group 2', 'description': 'SRP followed by 1.2% rosuvastatin (RSV) gel', 'interventionNames': ['Drug: Rosuvastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group 3', 'description': 'SRP followed by 1.2% Atorvastatin (ATV) gel', 'interventionNames': ['Drug: Atorvastatin']}], 'interventions': [{'name': 'placebo', 'type': 'DRUG', 'otherNames': ['inactive drug'], 'description': 'Oral prophylaxis followed by placement of placebo gel', 'armGroupLabels': ['group 1']}, {'name': 'Rosuvastatin', 'type': 'DRUG', 'otherNames': ['RSV'], 'description': 'Oral prophylaxis followed by placement of rosuvastatin gel', 'armGroupLabels': ['group 2']}, {'name': 'Atorvastatin', 'type': 'DRUG', 'otherNames': ['ATV'], 'description': 'Oral prophylaxis followed by placement of atorvastatin gel', 'armGroupLabels': ['group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '560002', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Government Dental College and Research Institute', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Government Dental College and Research Institute, Bangalore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and HOD, Dept of Periodontology', 'investigatorFullName': 'Dr. A R Pradeep', 'investigatorAffiliation': 'Government Dental College and Research Institute, Bangalore'}}}}