1.2% Rosuvastatin Gel As A Local Agent In Smokers With Chronic Periodontitis

1.2% Rosuvastatin Gel As A Local Drug Delivery Agent In Smokers With Chronic Periodontitis- A Randomized Controlled Clinical Trial.

The purpose of the present study was to evaluate the effects of subgingival delivery of Rosuvastatin gel as an adjunct to scaling and root planing in Smokers With Chronic Periodontitis (CP) patients.

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Drug: SRP plus placebo gel; Drug: SRP plus Rosuvastatin gel

Detailed Description

Background: Periodontal diseases are multi-factorial in etiology, and bacteria are one among these etiologic agents. However, mechanical therapy itself may not always reduce or eliminate the anaerobic infection at the base of the pocket, within the gingival tissues. To overcome this, various systemic and local drug delivered antimicrobials have been used as an adjunct to scaling and root planing (SRP).The present study aims to explore the efficacy of 1.2% rosuvastatin (RSV) gel local drug delivery as an adjunct to SRP in smokers with chronic periodontitis (CP).

Methods: Sixty subjects were randomly allocated into two treatment groups: SRP with placebo gel (group 1), SRP with 1.2% RSV gel (group 2). Clinical parameters were recorded at baseline, 6 and 9 months. Radiographic assessment was done using computer aided software at baseline, 6 and 9 months.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 560002
      • Government Dental College and Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Systemically healthy CP subjects aged between 30-50 years who are current smokers with no history of periodontal therapy or use of antibiotics in past 6 months, having sites with intrabony defect depth (IBD) ≥ 3mm (distance between alveolar crest and base of the defect on intraoral periapical radiograph) along with PPD ≥5 mm or CAL ≥3 mm in an asymptomatic tooth were included in the study.

A subject was considered as a current smoker if he regularly smoked more than 10 cigarettes/day for a minimum of 5 years

Exclusion Criteria:

• Former smokers, i.e. subjects who had previously been smokers but stopped their habit, and non-smokers were excluded. Subjects allergic to statins, on systemic statin therapy, with any known systemic disease or any other systemic inflammation/ infection which could alter the course of periodontal disease and users of tobacco in any other form than cigarettes were excluded from the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Rosuvastatin Group; Oral prophylaxis followed by 1.2% Rosuvastatin drug in gel form placed in intrabony defects	Drug: SRP plus Rosuvastatin gel; SRP followed by Rosuvastatin placement into intrabony defect
Placebo Comparator: Placebo Group; Oral prophylaxis followed by placebo gel placement in intrabony defects	Drug: SRP plus placebo gel; SRP followed by placebo gel placement into intrabony defect

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Defect depth reduction (%)	assessed in percentage	Change from baseline to 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
probing depth (mm)	measured in mm	Change from baseline to 9 months
clinical attachment level (mm)	measured in mm	Change from baseline to 9 months
modified sulcus bleeding index	scale from 0-3	Change from baseline to 9 months
Plaque Index	scale from 0-3	Change from baseline to 9 months

Collaborators and Investigators

• Sponsor: Government Dental College and Research Institute, Bangalore

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: February 2, 2017
• First Submitted That Met QC Criteria: February 2, 2017
• First Posted (Estimate): February 3, 2017

Study Record Updates

• Last Update Posted (Estimate): February 3, 2017
• Last Update Submitted That Met QC Criteria: February 2, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium
• Other Study ID Numbers: GDCRI/ACM/PG/PhD/2/2014-2015HB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED