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

Government Dental College and Research Institute, Bangalore

Status and phase: Completed; Phase 3; Phase 2

Conditions: Chronic Periodontitis

Treatments: Drug: SRP plus Rosuvastatin gel; Drug: SRP plus placebo gel

Study type: Interventional

Funder types: Other

Identifiers

NCT03043196

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

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 30 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Rosuvastatin Group

Active Comparator group

Description:

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

Treatment:

Drug: SRP plus Rosuvastatin gel

Placebo Group

Placebo Comparator group

Description:

Oral prophylaxis followed by placebo gel placement in intrabony defects

Treatment:

Drug: SRP plus placebo gel