Department of Periodontics, GDCRI Bangalore
Bangalore, Karnataka, 560002, India
NCT Number: NCT03745300
Statins are specific competitive inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, known for its hypolipidemic actions, possessing biologically significant anti-inflammatory and antioxidant properties, exerts anabolic effects on bone through expression of BMP - 2, have paved way in periodontal regeneration. The present study aims to evaluate and compare the efficacy of subgingivally delivered 1.2% Atorvastatin (ATV) and 1.2% Simvastatin (SMV) gel local drug delivery and redelivery systems as an adjunct to scaling and root planning (SRP) in chronic periodontitis (CP) subjects with diabetes mellitus(DM).
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Notify Me35 year–55 year
All sexes
Interventional
Phase 2 / Phase 3
Bangalore, Karnataka, 560002, India
Statins are specific competitive inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, known for its hypolipidemic actions, possessing biologically significant anti-inflammatory and antioxidant properties, exerts anabolic effects on bone through expression of BMP - 2, have paved way in periodontal regeneration. The present study aims to evaluate and compare the efficacy of subgingivally delivered 1.2% Atorvastatin (ATV) and 1.2% Simvastatin (SMV) gel local drug delivery and redelivery systems as an adjunct to scaling and root planning (SRP) in chronic periodontitis (CP) subjects with diabetes mellitus(DM). 120 subjects with intrabony defects were divided into three groups;group 1- SRP plus 1.2% ATV ; group 2- SRP PLUS 1.2% SMV; and group 3- SRP plus placebo gel. Clinical and radiographic measurements were taken at baseline, at 6 months and respective gels were redelivered subgingivally in respective groups . Measurements were repeated again at 3 months i.e. 9 months from baseline.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Scaling and Root Planing (SRP) followed by placement of atorvastatin gel
Other names: ATV
Scaling and Root Planing (SRP) followed by placement of simvastatin gel
Other names: SMV
Scaling and Root Planing (SRP) followed by placement of placebo gel
Other names: inactive drug
Time frame: 6 and 9 months
assessed in percentage
Time frame: baseline, 6 and 9 months
Time frame: baseline, 6 and 9 months
Time frame: baseline, 6 and 9 months
Time frame: baseline, 6 and 9 months
Government Dental College and Research Institute, Bangalore
Other
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