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

No results posted yet for this study

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

ATORVASTATIN

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

PLACEBO

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03745300 on ClinicalTrials.gov