Chronic Periodontitis, Type2 Diabetes
Conditions
Brief summary
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.
Detailed 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.
Interventions
SRP followed by 1.2% Rosuvastatin placement into intrabony defect
SRP followed by placebo gel placement into intrabony defect
Sponsors
Government Dental College and Research Institute, Bangalore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Defect depth reduction (%) | Change from baseline to 9 months | Assessed in percentage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| probing depth (mm) | Change from baseline to 9 months | measured in mm |
| clinical attachment level (mm) | Change from baseline to 9 months | measured in mm |
| modified sulcus bleeding index | Change from baseline to 9 months | scale from 0-3 |
| plaque index | Change from baseline to 9 months | scale from 0-3 |
Countries
India
Outcome results
None listed