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

Government Dental College and Research Institute, Bangalore

Status and phase: Completed; Phase 3; Phase 2

Conditions: Chronic Periodontitis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02516111

GDCRI/ACM/PG/PhD/2/2013-2014M

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: Female

Ages: 30 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 4 patient groups

Open flap debridement group

Active Comparator group

Description:

SRP with Open flap debridement (OFD) alone for treating intrabony defect

Treatment:

Procedure: Open flap debridement (OFD)

PRF group

Active Comparator group

Description:

SRP with Open flap debridement (OFD) with autologous Platelet rich fibrin (PRF) placement into intrabony defect

Treatment:

Biological: OFD with PRF

Alendronate group

Active Comparator group

Description:

SRP with Open flap debridement (OFD) with 1% Alendronate (ALN) placement into intrabony defect

Treatment:

Drug: OFD with ALN

Atorvastatin group

Active Comparator group

Description:

SRP with Open flap debridement (OFD) with 1.2% Atorvastatin (ATV) placement into intrabony defect

Treatment:

Drug: OFD with ATV