1.2% Rosuvastatin Subgingivally Delivered In Chronic Periodontitis With Type 2 Diabetes Mellitus

Government Dental College and Research Institute, Bangalore

Status and phase: Completed; Phase 3; Phase 2

Conditions: Type2 Diabetes; Chronic Periodontitis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02985099

GDCRI/ACM/PG/PhD/2/2013-2014DK

Details and patient eligibility

About

The purpose of the present study was to evaluate the effects of subgingival delivery of 1.2% Rosuvastatin (RSV) gel as an adjunct to scaling and root planing in chronic periodontitis (CP) with Type 2 diabetes mellitus patients.

Full description

Background: The purpose of this double-masked, randomized, controlled clinical trial was to evaluate the effects of subgingival delivery of 1.2% Rosuvastatin gel as an adjunct to scaling and root planing (SRP) on clinical and radiographic parameters and compare this method with SRP plus placebo gel alone in chronic periodontitis (CP) with type 2 DM patients.

Methods: Eighty CP patients with type 2 DM are included in this study. They were divided into two groups: 1) SRP + 1.2% Rosuvastatin gel (RSV group); 2) SRP + Placebo gel (Placebo group). At baseline, 3, 6 and 9 months after treatment, clinical measurements, including plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), clinical attachment level (CAL) and radiographic parameters intrabony defect depth (IBD), percentage change in radiographic defect depth reduction (DDR%) were assessed.

Enrollment: 80 patients

Sex: All

Ages: 30 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Type 2 diabetic patients with deep pockets (PD of ≥5mm or CAL ≥4mm) and vertical bone loss ≥3 mm on intraoral periapical radiographs
• Patients with ≥20 teeth with no history of periodontal therapy in the preceding 6 months nor under any antibiotic therapy

Exclusion criteria

• Patients with any other known systemic disease
• Patients on systemic statin therapy
• Known or suspected allergy to statin supplementation
• Patients with aggressive periodontitis
• Tobacco use in any form, smokers, alcoholics
• Immunocompromised patients
• Pregnant or lactating females

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 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