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 | Completed Phase 2

• 1 other identifier: GDCRI/ACM/PG/Ph.D/5/2016-2017H
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• change in defect depth

  assessed in percentage

  6 and 9 months

Secondary Outcomes (4)

• 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

Study Arms (3)

GROUP 1

ACTIVE COMPARATOR

Scaling and root planing (SRP) followed by 1.2% atorvastatin gel local drug delivery

Drug: ATORVASTATIN

GROUP 2

ACTIVE COMPARATOR

Scaling and root planing (SRP) followed by 1.2% simvastatin gel local drug delivery

Drug: SIMVASTATIN

GROUP 3

PLACEBO COMPARATOR

Scaling and root planing (SRP) followed by placebo gel local drug delivery

Drug: PLACEBO

Interventions

ATORVASTATIN DRUG

Scaling and Root Planing (SRP) followed by placement of atorvastatin gel

Also known as: ATV

GROUP 1

SIMVASTATIN DRUG

Scaling and Root Planing (SRP) followed by placement of simvastatin gel

Also known as: SMV

GROUP 2

PLACEBO DRUG

Scaling and Root Planing (SRP) followed by placement of placebo gel

Also known as: inactive drug

GROUP 3

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• )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.

Sponsors & Collaborators

• Government Dental College and Research Institute, Bangalore: lead

Study Sites (1)

Department of Periodontics, GDCRI Bangalore

Bangalore, Karnataka, 560002, India

Location

MeSH Terms

Interventions

Atorvastatin; Simvastatin

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Avani R Pradeep, MDS

  GDCRI, Bangalore, INDIA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor and HOD, Department of periodontology

Study Record Dates

• First Submitted: November 2, 2018
• First Posted: November 19, 2018
• Study Start: March 3, 2017
• Primary Completion: December 22, 2017
• Study Completion: December 22, 2017
• Last Updated: November 19, 2018

Record last verified: 2018-11

Locations

IN (1)