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

Government Dental College and Research Institute, Bangalore

Status and phase: Completed; Phase 2

Conditions: Three Wall Intrabony Defects in Chronic Periodontitis

Treatments: Biological: Platelet rich fibrin; Drug: Platelet rich fibrin and simvastatin; Procedure: Open Flap Debridement alone

Study type: Interventional

Funder types: Other

Identifiers

NCT02120872

GDCRI/ACM/PG/PhD/2011-2012/E

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 90 patients

Sex: All

Ages: 25 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups

PRF and SMV Group

Active Comparator group

Description:

sites treated with Open Flap Debridement with Platelet Rich Fibrin along with Simvastatin

Treatment:

Drug: Platelet rich fibrin and simvastatin

PRF Group

Sham Comparator group

Description:

sites treated with Open Flap Debridement with autologous Platelet Rich Fibrin

Treatment:

Biological: Platelet rich fibrin

OFD Group

Other group

Description:

sites treated with Open Flap Debridement i.e. conventional flap surgery

Treatment:

Procedure: Open Flap Debridement alone