Comparative Evaluation Of 1.2% Atorvastatin and 1.2% Simvastatin Gel Local Drug Delivery And Redelivery In Chronic Periodontitis Subjects With Diabetes Mellitus: A Randomized Controlled Clinical Trial.
NCT03745300 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2018-11-19
Summary
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).
Conditions
- Chronic Periodontitis Wth Diabetes Mellitus
Interventions
- DRUG
-
Scaling and Root Planing (SRP) followed by placement of atorvastatin gel
- DRUG
-
SIMVASTATIN
Scaling and Root Planing (SRP) followed by placement of simvastatin gel
- DRUG
-
Scaling and Root Planing (SRP) followed by placement of placebo gel
Sponsors & Collaborators
-
Government Dental College and Research Institute, Bangalore
lead OTHER
Principal Investigators
-
Avani R Pradeep, MDS · GDCRI, Bangalore, INDIA
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 35 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-03-03
- Primary Completion
- 2017-12-22
- Completion
- 2017-12-22
Countries
- India
Study Locations
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