Platelet Rich Fibrin Combined With Simvastatin for Treatment of Intrabony Defect in Chronic Periodontitis

Phase 2CompletedNCT02120872

Government Dental College and Research Institute, Bangalore90 enrolled

Overview

The purpose of the present study was to investigate the efficacy of autologous Platelet rich fibrin (PRF) or PRF and Simvastatin (SMV) with open flap debridement (OFD) in the treatment of three wall intrabony defects in comparison to OFD alone.

90 systemically healthy subjects were divided randomly into three groups (30 subjects in each group, per subject one site). Control group consisted of the sites treated with OFD and test groups sites were treated with OFD with autologous PRF or PRF with SMV. Site-specific plaque index (PI), sulcus bleeding index (mSBI), probing depth (PD), relative attachment level (RAL) and intrabony defect (IBD) depth reduction was measured at baseline and 9 month after surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Three Wall Intrabony Defects in Chronic Periodontitis

Interventions

Platelet rich fibrin and simvastatinDRUG

Three wall intrabony defect sites treated with Open Flap Debridement. 0.1 mL prepared SMV gel (1.2 mg/0.1 mL) was mixed with PRF. The PRF - SMV mixture was delivered to the defect.

Platelet rich fibrinBIOLOGICAL

Three wall intrabony defect sites treated with Open Flap Debridement. PRF was placed into the intrabony defect.

Open Flap Debridement alonePROCEDURE

Three wall intrabony defect sites treated with Open Flap Debridement only. No PRF or SMV was delivered to the defect.

Eligibility

Sex: ALLMin age: 25 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects with the diagnosis of chronic periodontitis * presence of three walled intrabony defects (IBD) ≥ 3 mm deep (distance between alveolar crest and base of the defect on intraoral periapical radiograph \[IOPA\]) * interproximal probing depth (PD) ≥ 5 mm following scaling and root planing (SRP) in asymptomatic tooth Exclusion Criteria: * Subjects, with the diagnosis of aggressive periodontitis, * with known systemic illness and taking medications known to affect the outcomes of periodontal therapy * insufficient platelet count (\< 200,000/mm3), * pregnancy / lactation * use of any form of tobacco * unacceptable oral hygiene (if plaque index \[PI\] (Silness \& Loe 1964) \>1.5) after the reevaluation of phase I therapy * teeth with furcation defects * non-vital * mobility of tooth ≥ Grade II

Locations (1)

Government Dental College and Research Institute

Bangalore, Karnataka, India

Outcomes

Primary Outcomes

The primary outcome measure of the study was defect depth reduction evaluated radiographically

Time frame: At baseline and 9 month after surgery

Secondary Outcomes

Probing Depth

Time frame: At baseline and 9 month after surgery

Relative Attachment Level

Time frame: At baseline and 9 month after syrgery

modified Sulcul Bleeding Index

Time frame: At baseline and 9 month after surgery

Plaque Index

Time frame: At baseline and 9 month after surgery

Data from ClinicalTrials.gov

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