Chronic Periodontitis
Conditions
Brief summary
The present study is designed as a single-centre, randomized, controlled clinical trial to evaluate and compare the clinical and radiographic efficacy of two local drug delivery systems containing 1.2% RSV gel and 1.2% ATV gel in treatment of intrabony defects in patients with chronic periodontitis as an adjunct to SRP.
Detailed description
Background: Rosuvastatin (RSV) and Atorvastatin (ATV) are known to inhibit osteoclastic bone resorption and were proposed to have osteostimulative properties by causing osteoblast differentiation in vivo and in vitro as shown by an increase in matrix formation. The aim of the present study is to evaluate and compare the efficacy of 1.2% RSV and 1.2% ATV gel as local drug delivery systems in adjunct to scaling and root planning (SRP) for the treatment of intrabony defects in patients with chronic periodontitis (CP). Methods: A total of 90 intrabony defects were treated with either 1.2% RSV, 1.2% ATV or placebo gel LDD after SRP. Clinical parameters (plaque index, modified sulcus bleeding index, probing depth and clinical attachment level) were recorded at baseline and 6 months. Radiographic intrabony defect depth change was calculated on standardized radiographs by using image analysis software at 6 months.
Interventions
DRUGSRP with RSV gel LDD
After SRP, 1.2% Rosuvastatin (RSV) gel was delivered subgingivally into the pocket
DRUGSRP with ATV gel LDD
After SRP, 1.2% Atorvastatin (ATV) gel was delivered subgingivally into the pocket
DRUGSRP with placebo gel LDD
After SRP, placebo gel was delivered subgingivally into the pocket
Sponsors
Government Dental College and Research Institute, Bangalore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Systemically healthy patients with PD ≥5mm or CA loss ≥4mm and vertical bone loss ≥3 mm on intraoral periapical radiographs with no history of periodontal therapy or use of antibiotics in the preceding 6 months were included
Exclusion criteria
* Patients with a known systemic disease; * known or suspected allergy to statin group; * on systemic statin therapy; * with aggressive periodontitis; * who used tobacco in any form; * alcoholics; * immunocompromised patients; * pregnant or lactating females were excluded from the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in intrabony defect depth from baseline to 6 months | Baseline to 6 months | Radiographic defect depth reduction (DDR) in the baseline to 6 months interval wiil be measured |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in plaque index (PI) from baseline to 6 months | Baseline to 6 months | Reduction in plaque index (PI) from baseline to 6 months wiil be measured |
| Change in modified sulcus bleeding index (mSBI) from baseline to 6 months | Baseline to 6 months | Reduction in modified sulcus bleeding index (mSBI) from baseline to 6 months wiil be measured |
| Change in probing depth (PD) from baseline to 6 months | Baseline to 6 months | Reduction in probing depth (PD) from baseline to 6 months wiil be measured |
| Change in clinical attachment (CA) level from baseline to 6 months | Baseline to 6 months | Reduction in clinical attachment (CA) level from baseline to 6 months wiil be measured |
Outcome results
None listed