Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2026-01-08 @ 9:51 PM
Study NCT ID:
NCT02386033
Status:
COMPLETED
Last Update Posted:
2015-03-11
First Post:
2014-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atorvastatin in the Treatment of Mandibular Degree II Furcation Defects
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'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-05', 'studyFirstSubmitDate': '2014-11-30', 'studyFirstSubmitQcDate': '2015-03-05', 'lastUpdatePostDateStruct': {'date': '2015-03-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'amount of bone fill', 'timeFrame': 'baseline to 9 months'}], 'secondaryOutcomes': [{'measure': 'change in Relative vertical clinical attachment level', 'timeFrame': 'baseline to 9 months'}, {'measure': 'change in RHCAL (relative horizontal clinical attachment level)', 'timeFrame': 'baseline to 9 months'}, {'measure': 'change in probing depth', 'timeFrame': 'baseline to 9 months'}, {'measure': 'change in site specific plaque index', 'timeFrame': 'baseline to 9 months'}, {'measure': 'change in modified sulcus bleeding index', 'timeFrame': 'baseline to 9 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Periodontitis']}, 'descriptionModule': {'briefSummary': 'ABSTARCT Background: Atorvastatin is an inhibitor of 3-hydroxy-2-methyl-glutaryl coenzyme A reductase. Lately, it has shown to have anti-inflammatory and bone stimulatory effects. The aim of the current study is to explore the effectiveness of 1.2% atorvastatin (ATV) as an adjunct to scaling and root planning (SRP) in the treatment of mandibular degree II furcation defects.\n\nMethod: A total of sixty subjects were randomly assigned to two treatment groups. 1. SRP plus placebo gel 2. SRP plus 1.2% ATV gel. Clinical parameters like probing depth (PD), relative vertical clinical attachment level (RVCAL) , relative horizontal clinical attachment level (RHCAL), modified sulcus bleeding index (mSBI) and site specific plaque index were recorded at baseline and then at 3, 6 and 9 months. The radiological assessment of bone defect fill was done at 6 and 9 months, using a computer-aided software.', 'detailedDescription': 'Two groups were made. One was delivered with ATV after SRP, the other was delivered with placebo gel after SRP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* lower first molars demonstrating a probing pocket depth of 5 mm and horizontal probing depth of 3 mm following phase 1 therapy, with furcation defects (degree II) present bucally in asymptomatic, vital lower first molars, with a furcation radiolucency on a periapical radiograph of the molars.\n\nExclusion Criteria:\n\n* patients with systemic diseases like cardiovascular disease\n* diabetes or HIV infection or on medications like corticosteroids which may impede the healing in periodontal tissues.\n* pregnant/lactating females\n* tobacco users\n* alcoholics\n* patients with unsatisfactory oral hygiene (plaque index greater than 1.5)\n* teeth having gingival recession, caries involving pulp, intrabony defect present interproximally, grade 2/3 mobility\n* Furthermore, patients allergic to ATV or other statins or those taking ATV/other statins systemically were excluded.'}, 'identificationModule': {'nctId': 'NCT02386033', 'briefTitle': 'Atorvastatin in the Treatment of Mandibular Degree II Furcation Defects', 'organization': {'class': 'OTHER', 'fullName': 'Government Dental College and Research Institute, Bangalore'}, 'officialTitle': 'Clinical Efficacy of Subgingivally Delivered Atorvastatin in the Treatment of Mandibular Degree II Furcation Defects: A Randomized Controlled Clinical Trial .', 'orgStudyIdInfo': {'id': 'GDCRI/ACM/PG/PhD/2/2013-2014AB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'SRP plus placebo', 'description': 'SRP was done for all the subjects. Placebo gel was delivered subgingivally into the pocket', 'interventionNames': ['Drug: Placebo Gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SRP plus Atorvastatin', 'description': 'SRP was done for all the subjects. Atorvastatin was delivered in the pocket subgingivally', 'interventionNames': ['Drug: Atorvastatin (ATV)']}], 'interventions': [{'name': 'Atorvastatin (ATV)', 'type': 'DRUG', 'otherNames': ['ATV gel'], 'description': 'After SRP, ATV gel was delivered subgingivally into the pocket', 'armGroupLabels': ['SRP plus Atorvastatin']}, {'name': 'Placebo Gel', 'type': 'DRUG', 'description': 'After SRP, placebo gel was delivered subgingivally into the pocket', 'armGroupLabels': ['SRP plus placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Government Dental College and Research Institute, Bangalore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and head, department of periodontics', 'investigatorFullName': 'Dr. A R Pradeep', 'investigatorAffiliation': 'Government Dental College and Research Institute, Bangalore'}}}}