Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-04-04 @ 6:31 PM
Study NCT ID:
NCT02455869
Status:
COMPLETED
Last Update Posted:
2015-05-28
First Post:
2015-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Alendronate 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069059', 'term': 'Atorvastatin'}, {'id': 'D019386', 'term': 'Alendronate'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-25', 'studyFirstSubmitDate': '2015-05-19', 'studyFirstSubmitQcDate': '2015-05-25', 'lastUpdatePostDateStruct': {'date': '2015-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', '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', 'timeFrame': '3,6 and 9 months', 'description': 'Plaque index will be measured at 3, 6 and 9 months'}, {'measure': 'Modified sulcus bleeding index', 'timeFrame': '3,6 and 9 months]', 'description': 'Modified sulcus bleeding index will be measured at 3, 6 and 9 months'}, {'measure': 'Probing pocket depth', 'timeFrame': '3,6 and 9 months]', 'description': 'Probing pocket depth will be measured at 3, 6 and 9 months'}, {'measure': 'Clinical attachment level', 'timeFrame': '3,6 and 9 months]', 'description': 'Clinical attachment level will be measured at 3, 6 and 9 months'}]}, '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 efficacy of two local drug delivery systems containing 1% ALN gel and 1.2% ATV gel in treatment of intrabony defects in patients with chronic periodontitis as an adjunct to SRP.', 'detailedDescription': 'Background: Alendronate and Atorvastatin 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% ALN and 1.2% ATV gel as a local drug delivery system in adjunct to scaling and root planning (SRP) for the treatment of intrabony defects in patients with chronic periodontitis.\n\nMethods: A total of 90 intrabony defects were treated with either1%ALN, 1.2% ATV or placebo gel. Clinical parameters (plaque index, modified sulcus bleeding index, probing depth \\[PD\\], and clinical attachment level \\[CAL\\]) were recorded at baseline, 3, 6 and 9 months. Radiographic parameters intrabony defect depth (IBD) and defect depth reduction (DDR%) was calculated on standardized radiographs by using image analysis software at 6 and 9 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Systemically healthy patients with PDs ≥5mm or CALs ≥4 to 6mm 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 the ALN/bisphosphonate group and ATV/statin group;\n* on systemic ALN/bisphosphonate and therapy ATV/statin group;\n* with aggressive periodontitis;\n* who used tobacco in any form;\n* alcoholics;\n* immunocompromised patients;\n* and pregnant or lactating females were excluded from the study'}, 'identificationModule': {'nctId': 'NCT02455869', 'briefTitle': 'Comparison of Alendronate With Atorvastatin in Chronic Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'Government Dental College and Research Institute, Bangalore'}, 'officialTitle': 'Comparative Evaluation of Subgingivally Delivered 1% Alendronate Versus 1.2% Atorvastatin Gel in Treatment of Chronic Periodontitis: a Randomized Placebo Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'GDCRI/ACM/PG/PhD/2/2013-2014J'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'SRP plus placebo SRP was done for all the subjects. Placebo gel was delivered subgingivally into the pocket', 'interventionNames': ['Drug: SRP and Placebo gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Atorvastatin group', 'description': 'SRP plus Atorvastatin SRP was done for all the subjects. Atorvastatin was delivered in the pocket subgingivally', 'interventionNames': ['Drug: SRP and Atorvastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Alendronate Group', 'description': 'Alendronate SRP plus Alendronate SRP was done for all the subjects. Alendronate was delivered in the pocket subgingivally', 'interventionNames': ['Drug: SRP and Alendronate']}], 'interventions': [{'name': 'SRP and Placebo gel', 'type': 'DRUG', 'description': 'After SRP, placebo gel was delivered subgingivally into the pocket', 'armGroupLabels': ['Placebo group']}, {'name': 'SRP and Atorvastatin', 'type': 'DRUG', 'description': 'After SRP, Atorvastatin gel was delivered subgingivally into the pocket', 'armGroupLabels': ['Atorvastatin group']}, {'name': 'SRP and Alendronate', 'type': 'DRUG', 'description': 'After SRP, Alendronate gel was delivered subgingivally into the pocket', 'armGroupLabels': ['Alendronate Group']}]}, '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'}}}}