NCT02516111

Comparison of Autologous PRF, 1% Alendronate and 1.2% Atorvastatin Gel in Chronic Periodontitis Treatment

Comparative Evaluation of Autologous PRF, 1% Alendronate and 1.2% Atorvastatin Gel in Treatment of 2/3-walled Intrabony Defects in Chronic Periodontitis Subjects: a Randomized Controlled Clinical Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Government Dental College and Research Institute, Bangalore · Academic / Other
• Sex: Female
• Age: 30 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The present study is designed as a single-centre, randomized, controlled clinical trial to evaluate and compare the clinical efficacy of autologous PRF, 1% alendronate (ALN) and 1.2% atorvastatin (ATV) gel placement with open flap debriedement in treatment of intrabony defects in patients with chronic periodontitis.

Detailed description

Background: Platelet-rich fibrin (PRF) is a second-generation platelet concentrate which releases various growth factors that promote tissue regeneration. Alendronate and Atorvastatin 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 autologous PRF, 1% alendronate and 1.2% atorvastatin gel placement with open flap debriedement in treatment of intrabony defects in patients with chronic periodontitis. Methods: 120 CP subjects with IBD ≥3 mm deep and probing depth (PD) ≥5 mm, following scaling and root planing (SRP), were categorized into four treatment groups: 1) OFD 2) OFD with PRF 3) OFD with 1% ALN gel and 4) OFD with 1.2% ATV gel. Clinical parameters including site specific plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD) and relative attachment level (RAL) as well as percentage radiographic intrabony defect depth reduction (DDR) were recorded at baseline before surgery and 9 months post-operatively.

Conditions

• Chronic Periodontitis

Interventions

Type	Name	Description
PROCEDURE	Open flap debridement (OFD)	Oral prophylaxis followed by Open flap debridement (OFD)
BIOLOGICAL	OFD with PRF	Oral prophylaxis followed by Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement into the bone defect
DRUG	OFD with ALN	Oral prophylaxis followed by Open flap debridement (OFD) with 1% ALN gel placement into the bone defect
DRUG	OFD with ATV	Oral prophylaxis followed by Open flap debridement (OFD) with 1.2% ATV gel placement into the bone defect

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2015-08-05
• Last updated: 2015-08-05