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.

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).

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis Wth Diabetes Mellitus
• Intervention / Treatment: Drug: ATORVASTATIN; Drug: SIMVASTATIN; Drug: PLACEBO

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 560002
      • Department of Periodontics, GDCRI Bangalore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• well controlled type 2 diabetes mellitus patients classified based on criteria given by American diabetes association with CP with PD≥5mm and CAL ≥3mm and presence of IBD ≥ 3 mm (distance between alveolar crest and base of the defect on an intraoral periapical radiograph [IOPAR] after phase I therapy

Exclusion Criteria:

• 1)patients with known allergy to statins; 2) Patients with systemic conditions / medications known to affect the periodontal status; 3) aggressive and refractory periodontitis 4) Hematological disorders 5) pregnancy/lactation; and 6) Smoking and tobacco use in any form 7) Immunocompromised individuals.8). patients with poor plaque control. 9). non vital teeth, carious teeth warranting restorations, third molars and mobility of at least grade II were excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: GROUP 1; Scaling and root planing (SRP) followed by 1.2% atorvastatin gel local drug delivery	Drug: ATORVASTATIN; Scaling and Root Planing (SRP) followed by placement of atorvastatin gel; Other Names: ATV
ACTIVE_COMPARATOR: GROUP 2; Scaling and root planing (SRP) followed by 1.2% simvastatin gel local drug delivery	Drug: SIMVASTATIN; Scaling and Root Planing (SRP) followed by placement of simvastatin gel; Other Names: SMV
PLACEBO_COMPARATOR: GROUP 3; Scaling and root planing (SRP) followed by placebo gel local drug delivery	Drug: PLACEBO; Scaling and Root Planing (SRP) followed by placement of placebo gel; Other Names: inactive drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in defect depth	assessed in percentage	6 and 9 months

Secondary Outcome Measures

Outcome Measure	Time Frame
change in probing depth (PD)	baseline, 6 and 9 months
change in Clinical Attachment Level (CAL)	baseline, 6 and 9 months
CHANGE IN Plaque Index (PI)	baseline, 6 and 9 months
change in modified Sulcus Bleding Index (mSBI)	baseline, 6 and 9 months

Collaborators and Investigators

• Sponsor: Government Dental College and Research Institute, Bangalore

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 3, 2017
• Primary Completion (ACTUAL): December 22, 2017
• Study Completion (ACTUAL): December 22, 2017

Study Registration Dates

• First Submitted: November 2, 2018
• First Submitted That Met QC Criteria: November 15, 2018
• First Posted (ACTUAL): November 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 19, 2018
• Last Update Submitted That Met QC Criteria: November 15, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Diabetes Mellitus; Periodontitis; Chronic Periodontitis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Simvastatin
• Other Study ID Numbers: GDCRI/ACM/PG/Ph.D/5/2016-2017H

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No