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

Phase 2

Completed

• Conditions: Chronic Periodontitis
• Interventions: Procedure: Open flap debridement (OFD); Drug: OFD with ATV; Biological: OFD with PRF; Drug: OFD with ALN

• Registration Number: NCT02516111
• Lead Sponsor: Government Dental College and Research Institute, Bangalore

Brief 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.

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-08
• Study First Submitted: 2015-08-03
• Study First Submitted QC: 2015-08-04
• Last Update Submitted: 2015-08-04
• Study First Posted: 2015-08-05
• Last Update Posted: 2015-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open flap debridement group	Open flap debridement (OFD)	SRP with Open flap debridement (OFD) alone for treating intrabony defect
Atorvastatin group	OFD with ATV	SRP with Open flap debridement (OFD) with 1.2% Atorvastatin (ATV) placement into intrabony defect
PRF group	OFD with PRF	SRP with Open flap debridement (OFD) with autologous Platelet rich fibrin (PRF) placement into intrabony defect
Alendronate group	OFD with ALN	SRP with Open flap debridement (OFD) with 1% Alendronate (ALN) placement into intrabony defect

Primary Outcome Measures

Name	Time	Method
defect depth reduction (DDR)	Change from baseline to 9 months

Secondary Outcome Measures

Name	Time	Method
change in clinical attachment level (CAL)	Change from baseline to 9 months
change in probing pocket depths (PPD)	Change from baseline to 9 months
change in plaque index (PI)	Change from baseline to 9 months