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

NCT ID: NCT03043196

Last Updated: 2017-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2016-04-30

Brief Summary

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.

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.

Conditions

Chronic Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Rosuvastatin Group

Oral prophylaxis followed by 1.2% Rosuvastatin drug in gel form placed in intrabony defects

Group Type: ACTIVE_COMPARATOR

SRP plus Rosuvastatin gel

Intervention Type: DRUG

SRP followed by Rosuvastatin placement into intrabony defect

Placebo Group

Oral prophylaxis followed by placebo gel placement in intrabony defects

Group Type: PLACEBO_COMPARATOR

SRP plus placebo gel

Intervention Type: DRUG

SRP followed by placebo gel placement into intrabony defect

Interventions

SRP plus Rosuvastatin gel

SRP followed by Rosuvastatin placement into intrabony defect

Intervention Type: DRUG

SRP plus placebo gel

SRP followed by placebo gel placement into intrabony defect

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Government Dental College and Research Institute, Bangalore

OTHER

Sponsor Role: lead

Responsible Party

Dr. A R Pradeep

Professor and HOD, Dept of Periodontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Government Dental College and Research Institute

Bangalore, Karnataka, India

Countries

India

Other Identifiers

GDCRI/ACM/PG/PhD/2/2014-2015HB

Identifier Type: -

Identifier Source: org_study_id