Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-02-26 @ 12:42 AM
Study NCT ID:
NCT02372656
Status:
COMPLETED
Last Update Posted:
2015-02-26
First Post:
2014-11-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Simvastatin and Metformin 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': 'D008687', 'term': 'Metformin'}, {'id': 'D019821', 'term': 'Simvastatin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-20', 'studyFirstSubmitDate': '2014-11-30', 'studyFirstSubmitQcDate': '2015-02-20', 'lastUpdatePostDateStruct': {'date': '2015-02-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in defect depth reduction from baseline to 6 months and from baseline to 9 months', 'timeFrame': 'Baseline to 6 months and Baseline to 9 months', 'description': 'Radiographic defect depth reduction to measured at baseline, 6 and 9 months interval.'}], 'secondaryOutcomes': [{'measure': 'Plaque index will be measured at 3, 6 and 9 months', 'timeFrame': '3,6 and 9 months'}, {'measure': 'Modified sulcular bleeding index at 3, 6 and 9 months', 'timeFrame': '3 , 6 and 9 months'}, {'measure': 'Probing pocket depth at 3, 6 and 9 months', 'timeFrame': '3 , 6 and 9 months'}, {'measure': 'Clinical attachment level at 3, 6 and 9 months', 'timeFrame': '3 , 6 and 9 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Simvastatin, Metformin, Chronic periodontitis'], 'conditions': ['Chronic Periodontitis']}, 'descriptionModule': {'briefSummary': 'This randomized controlled clinical trial compares efficacy of 1.2% simvastatin with 1% metformin in chronic periodontitis subjects.', 'detailedDescription': 'Aim: To compare the efficacy of locally delivered 1.2% SMV gel and 1% MF gel in treatment of intrabony defects in chronic periodontitis subjects and compare it with placebo gel.\n\nMethods: Ninety subjects were categorized into three treatment groups: 1.2% Simvastatin (SMV), 1% Metformin (MF) and placebo gel after Scaling and root planning (SRP). Clinical parameters were recorded at baseline, 3, 6 and 9 months; they included plaque index (PI), modified sulcus bleeding index (mSBI), pocket probing depth (PPD), and clinical attachment level (CAL). Radiologic assessment of intra bony defect (IBD) and percentage defect depth reduction (DDR%) was done at baseline, 6 months and 9 months interval using computer-aided software\n\nResults: Mean PPD reduction and mean CAL gain was found to greater in SMV group than MF and placebo group at all visits. The DDR% was greater in SMV group as compared to MF and placebo group.\n\nConclusion: There was greater decrease in mSBI and PPD and more CAL gain with significant IBD depth reduction at the sites treated with SMV and MF as an adjunct to SRP in chronic periodontitis subjects with intrabony defects as compared to placebo. The effect was greater in case of SMV group, however there was no significant defect depth reduction as compared to MF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Systemically healthy subjects\n* Pocket depth ≥ 5 mm\n* Clinical attachment level ≥ 4 mm and vertical bone loss ≥ 3 mm on intraoral periapical radiographs, with no history of periodontal therapy in the last 6 months\n\nExclusion Criteria:\n\n* Subjects allergic to MF or SMV\n* Those on systemic MF or SMV therapy\n* Subjects with aggressive periodontitis\n* Immunocompromised subjects\n* Use of tobacco in any form, alcoholics\n* Lactating and pregnant females'}, 'identificationModule': {'nctId': 'NCT02372656', 'briefTitle': 'Simvastatin and Metformin in Chronic Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'Government Dental College and Research Institute, Bangalore'}, 'officialTitle': 'Comparison Of Efficacy Of Locally Delivered 1.2% Simvastatin And 1% Metformin Gel In Chronic Periodontitis: A Randomized Placebo Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'GDCRI/ACM/PG/PhD/10C/2013-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Placebo gel without active ingredient to be delivered at baseline, 3, 6 and 9 months.', 'interventionNames': ['Drug: Placebo gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': '1% Metformin', 'description': '1% metformin gel to be delivered at baseline, 3, 6 and 9 months.', 'interventionNames': ['Drug: 1% Metformin']}, {'type': 'ACTIVE_COMPARATOR', 'label': '1.2% Simvastatin', 'description': '1.2% Simvastatin to be delivered at baseline, 3, 6 and 9 months.', 'interventionNames': ['Drug: 1.2% Simvastatin']}], 'interventions': [{'name': 'Placebo gel', 'type': 'DRUG', 'otherNames': ['Placebo group'], 'description': 'Placebo gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months.', 'armGroupLabels': ['Placebo Group']}, {'name': '1% Metformin', 'type': 'DRUG', 'otherNames': ['1% Metformin group'], 'description': '1% Metformin gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months.', 'armGroupLabels': ['1% Metformin']}, {'name': '1.2% Simvastatin', 'type': 'DRUG', 'otherNames': ['1.2% Simvastatin group'], 'description': '1.2% Simvastatin gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months.', 'armGroupLabels': ['1.2% Simvastatin']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Government Dental College and Research Institute, Bangalore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dr. A R Pradeep', 'investigatorAffiliation': 'Government Dental College and Research Institute, Bangalore'}}}}