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

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03043196
• Other study ID #: GDCRI/ACM/PG/PhD/2/2014-2015HB
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 2, 2017
• Last updated: February 2, 2017
• Start date: June 2015
• Est. completion date: April 2016

Study information

• Verified date: February 2017
• Source: Government Dental College and Research Institute, Bangalore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Drug:
• SRP plus Rosuvastatin gel
SRP followed by Rosuvastatin placement into intrabony defect
• SRP plus placebo gel
SRP followed by placebo gel placement into intrabony defect

Locations

Country	Name	City	State
India	Government Dental College and Research Institute	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Government Dental College and Research Institute, Bangalore

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Defect depth reduction (%)	assessed in percentage	Change from baseline to 9 months
Secondary	probing depth (mm)	measured in mm	Change from baseline to 9 months
Secondary	clinical attachment level (mm)	measured in mm	Change from baseline to 9 months
Secondary	modified sulcus bleeding index	scale from 0-3	Change from baseline to 9 months
Secondary	Plaque Index	scale from 0-3	Change from baseline to 9 months