Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2026-02-09 @ 10:08 AM
Study NCT ID:
NCT02600520
Status:
COMPLETED
Last Update Posted:
2015-11-13
First Post:
2015-11-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Rosuvastatin With Atorvastatin 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-11', 'studyFirstSubmitDate': '2015-11-06', 'studyFirstSubmitQcDate': '2015-11-06', 'lastUpdatePostDateStruct': {'date': '2015-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in intrabony defect depth from baseline to 6 months', 'timeFrame': 'Baseline to 6 months', 'description': 'Radiographic defect depth reduction (DDR) in the baseline to 6 months interval wiil be measured'}], 'secondaryOutcomes': [{'measure': 'Change in plaque index (PI) from baseline to 6 months', 'timeFrame': 'Baseline to 6 months', 'description': 'Reduction in plaque index (PI) from baseline to 6 months wiil be measured'}, {'measure': 'Change in modified sulcus bleeding index (mSBI) from baseline to 6 months', 'timeFrame': 'Baseline to 6 months', 'description': 'Reduction in modified sulcus bleeding index (mSBI) from baseline to 6 months wiil be measured'}, {'measure': 'Change in probing depth (PD) from baseline to 6 months', 'timeFrame': 'Baseline to 6 months', 'description': 'Reduction in probing depth (PD) from baseline to 6 months wiil be measured'}, {'measure': 'Change in clinical attachment (CA) level from baseline to 6 months', 'timeFrame': 'Baseline to 6 months', 'description': 'Reduction in clinical attachment (CA) level from baseline to 6 months wiil be measured'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Periodontitis']}, 'descriptionModule': {'briefSummary': 'The present study is designed as a single-centre, randomized, controlled clinical trial to evaluate and compare the clinical and radiographic efficacy of two local drug delivery systems containing 1.2% RSV gel and 1.2% ATV gel in treatment of intrabony defects in patients with chronic periodontitis as an adjunct to SRP.', 'detailedDescription': 'Background: Rosuvastatin (RSV) and Atorvastatin (ATV) are known to inhibit osteoclastic bone resorption and were proposed to have osteostimulative properties by causing osteoblast differentiation in vivo and in vitro as shown by an increase in matrix formation. The aim of the present study is to evaluate and compare the efficacy of 1.2% RSV and 1.2% ATV gel as local drug delivery systems in adjunct to scaling and root planning (SRP) for the treatment of intrabony defects in patients with chronic periodontitis (CP).\n\nMethods: A total of 90 intrabony defects were treated with either 1.2% RSV, 1.2% ATV or placebo gel LDD after SRP. Clinical parameters (plaque index, modified sulcus bleeding index, probing depth and clinical attachment level) were recorded at baseline and 6 months. Radiographic intrabony defect depth change was calculated on standardized radiographs by using image analysis software at 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Systemically healthy patients with PD ≥5mm or CA loss ≥4mm and vertical bone loss ≥3 mm on intraoral periapical radiographs with no history of periodontal therapy or use of antibiotics in the preceding 6 months were included\n\nExclusion Criteria:\n\n* Patients with a known systemic disease;\n* known or suspected allergy to statin group;\n* on systemic statin therapy;\n* with aggressive periodontitis;\n* who used tobacco in any form;\n* alcoholics;\n* immunocompromised patients;\n* pregnant or lactating females were excluded from the study'}, 'identificationModule': {'nctId': 'NCT02600520', 'briefTitle': 'Comparison of Rosuvastatin With Atorvastatin in Chronic Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'Government Dental College and Research Institute, Bangalore'}, 'officialTitle': '1.2% Rosuvastatin Versus 1.2% Atorvastatin Local Drug Delivery in Treatment of Intrabony Defects in Chronic Periodontitis: A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'GDCRI/ACM/PG/PhD/2/2013-2014X'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Rosuvastatin Group', 'description': 'SRP followed by RSV gel LDD', 'interventionNames': ['Drug: SRP with RSV gel LDD']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Atorvastatin Group', 'description': 'SRP followed by ATV gel LDD', 'interventionNames': ['Drug: SRP with ATV gel LDD']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'SRP followed by placebo gel LDD', 'interventionNames': ['Drug: SRP with placebo gel LDD']}], 'interventions': [{'name': 'SRP with RSV gel LDD', 'type': 'DRUG', 'description': 'After SRP, 1.2% Rosuvastatin (RSV) gel was delivered subgingivally into the pocket', 'armGroupLabels': ['Rosuvastatin Group']}, {'name': 'SRP with ATV gel LDD', 'type': 'DRUG', 'description': 'After SRP, 1.2% Atorvastatin (ATV) gel was delivered subgingivally into the pocket', 'armGroupLabels': ['Atorvastatin Group']}, {'name': 'SRP with placebo gel LDD', 'type': 'DRUG', 'description': 'After SRP, placebo gel was delivered subgingivally into the pocket', 'armGroupLabels': ['Placebo group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Government Dental College and Research Institute, Bangalore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor & Head, Department of Periodontology', 'investigatorFullName': 'Dr. A R Pradeep', 'investigatorAffiliation': 'Government Dental College and Research Institute, Bangalore'}}}}