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

Condition(s) targeted: Chronic Periodontitis

Intervention: Open flap debridement (OFD) (Procedure); OFD with PRF (Biological); OFD with ALN (Drug); OFD with ATV (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Government Dental College and Research Institute, Bangalore

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.

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: defect depth reduction (DDR)

Secondary outcome:

change in clinical attachment level (CAL)

change in probing pocket depths (PPD)

change in plaque index (PI)

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.

Minimum age: 30 Years. Maximum age: 50 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Systemically healthy patients with PDs ≥5mm or CALs ≥4 to 6mm 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 the ALN/ bisphosphonates or ATV/statin group

- On systemic ALN/ bisphosphonates or ATV/statin group

- With aggressive periodontitis

- Who used tobacco in any form

- Alcoholics

- Immunocompromised patients

- And pregnant or lactating females were excluded from the study

Starting date: September 2014
Last updated: August 4, 2015