Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-03-03 @ 5:03 PM
Study NCT ID:
NCT02119520
Status:
COMPLETED
Last Update Posted:
2014-04-21
First Post:
2014-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PLATELET RICH FIBRIN COMBINED WITH 1.2% ATORVASTATIN FOR TREATMENT OF INTRABONY DEFECTS IN CHRONIC PERIODONTITIS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-17', 'studyFirstSubmitDate': '2014-04-17', 'studyFirstSubmitQcDate': '2014-04-17', 'lastUpdatePostDateStruct': {'date': '2014-04-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage radiographic defect depth reduction', 'timeFrame': '9 months from baseline', 'description': 'Defect depth reduction will be assessed from baseline to 9 month post operatively on radiographs'}], 'secondaryOutcomes': [{'measure': 'change in probing depth', 'timeFrame': '9 months from baseline', 'description': 'probing depth will be assessed from gingival margin to pocket depth at baseline and 9 months postoperatively'}, {'measure': 'change in relative attachment level', 'timeFrame': '9 months from baseline', 'description': 'RAL will be assesed from fixed point on the stent at baseline and 9 months postoperatively'}, {'measure': 'change in plaque levels', 'timeFrame': '9 months from baseline', 'description': 'plaque levels were assessed at baseline and 9 months postoperatively'}, {'measure': 'change in gingival bleeding', 'timeFrame': '9 months from baseline', 'description': 'gingival bleeding was assesed at baseline and 9 months postoperatively'}, {'measure': 'change in gingival margin levels', 'timeFrame': '9 months from baseline', 'description': 'change in gingival margin levels were assesed at baseline and 9 months'}]}, 'conditionsModule': {'keywords': ['Periodontitis', 'Surgery', 'Growth Factors', 'Statins'], 'conditions': ['Periodontitis']}, 'descriptionModule': {'briefSummary': 'Current study was designed to evaluate the combined efficacy of PRF and 1.2% ATV gel with open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nthe presence of 3- wall IBD ≥3 mm deep (distance between alveolar crest and base of the defect on an intraoral periapical radiograph \\[IOPA\\]) along with an interproximal probing depth (PD) ≥5 mm after phase I therapy (scaling and root planing \\[SRP\\]) in asymptomatic teeth.\n\nExclusion Criteria:\n\n1\\) Agressive Periodontitis subjects; 2) Systemic conditions known to affect the periodontal status; 3) medications known to affect the outcomes of periodontal therapy; 4) Hematological disorders and insufficient platelet count (\\<200,000/mm3); 5) pregnancy/lactation; and 6) Smoking and tobacco use in any form 7) Immunocompromised individuals.'}, 'identificationModule': {'nctId': 'NCT02119520', 'briefTitle': 'PLATELET RICH FIBRIN COMBINED WITH 1.2% ATORVASTATIN FOR TREATMENT OF INTRABONY DEFECTS IN CHRONIC PERIODONTITIS', 'organization': {'class': 'OTHER', 'fullName': 'Government Dental College and Research Institute, Bangalore'}, 'orgStudyIdInfo': {'id': 'GDCRI/ACM/PG/PhD/2011-2012/D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Platelet rich fibrin + atorvastatin', 'description': 'In Platelet rich fibrin+ATV group PRF combined with 10 µl of 1.2% ATV was inserted into the depth of the IBD', 'interventionNames': ['Drug: Platelet rich fibrin +Atorvastatin']}, {'type': 'SHAM_COMPARATOR', 'label': 'Platelet rich fibrin', 'description': 'In Platelet rich fibrin group PRF was inserted into the depth of the IBD.', 'interventionNames': ['Drug: Platelet rich fibrin']}, {'type': 'OTHER', 'label': 'Open flap debridement', 'description': 'open flap debridement was followed by no grafting or regenerative intervention.', 'interventionNames': ['Procedure: open flap debridement']}], 'interventions': [{'name': 'Platelet rich fibrin +Atorvastatin', 'type': 'DRUG', 'armGroupLabels': ['Platelet rich fibrin + atorvastatin']}, {'name': 'Platelet rich fibrin', 'type': 'DRUG', 'armGroupLabels': ['Platelet rich fibrin']}, {'name': 'open flap debridement', 'type': 'PROCEDURE', 'armGroupLabels': ['Open flap debridement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '560002', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Govt dental college and research institute', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}], 'overallOfficials': [{'name': 'Avani R Pradeep, MDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor'}]}, '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'}}}}