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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Procedure: Open flap debridement (OFD); Biological: OFD with PRF; Drug: OFD with ALN; Drug: OFD with ATV

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Open flap debridement group; SRP with Open flap debridement (OFD) alone for treating intrabony defect	Procedure: Open flap debridement (OFD); Oral prophylaxis followed by Open flap debridement (OFD)
Active Comparator: PRF group; SRP with Open flap debridement (OFD) with autologous Platelet rich fibrin (PRF) placement into intrabony defect	Biological: OFD with PRF; Oral prophylaxis followed by Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement into the bone defect
Active Comparator: Alendronate group; SRP with Open flap debridement (OFD) with 1% Alendronate (ALN) placement into intrabony defect	Drug: OFD with ALN; Oral prophylaxis followed by Open flap debridement (OFD) with 1% ALN gel placement into the bone defect
Active Comparator: Atorvastatin group; SRP with Open flap debridement (OFD) with 1.2% Atorvastatin (ATV) placement into intrabony defect	Drug: OFD with ATV; Oral prophylaxis followed by Open flap debridement (OFD) with 1.2% ATV gel placement into the bone defect

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
defect depth reduction (DDR)	Change from baseline to 9 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Government Dental College and Research Institute, Bangalore

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: August 3, 2015
• First Submitted That Met QC Criteria: August 4, 2015
• First Posted (Estimate): August 5, 2015

Study Record Updates

• Last Update Posted (Estimate): August 5, 2015
• Last Update Submitted That Met QC Criteria: August 4, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: GDCRI/ACM/PG/PhD/2/2013-2014M