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

NCT02120872 | Completed Phase 2 DMC

• 1 other identifier: GDCRI/ACM/PG/PhD/2011-2012/E
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Three Wall Intrabony Defects in Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

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

  At baseline and 9 month after surgery

Secondary Outcomes (4)

• Probing Depth

  At baseline and 9 month after surgery

• Relative Attachment Level

  At baseline and 9 month after syrgery

• modified Sulcul Bleeding Index

  At baseline and 9 month after surgery

• Plaque Index

  At baseline and 9 month after surgery

Study Arms (3)

PRF and SMV Group

ACTIVE COMPARATOR

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

Drug: Platelet rich fibrin and simvastatin

PRF Group

SHAM COMPARATOR

sites treated with Open Flap Debridement with autologous Platelet Rich Fibrin

Biological: Platelet rich fibrin

OFD Group

OTHER

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

Procedure: Open Flap Debridement alone

Interventions

Platelet rich fibrin and simvastatin DRUG

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.

PRF and SMV Group

Platelet rich fibrin BIOLOGICAL

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

PRF Group

Open Flap Debridement alone PROCEDURE

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

OFD Group

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Government Dental College and Research Institute, Bangalore: lead

Study Sites (1)

Government Dental College and Research Institute

Bangalore, Karnataka, 560002, India

Location

MeSH Terms

Interventions

Simvastatin

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Avani R Pradeep, MDS

  Government Dental College and Research Institute, Bangalore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head of Department

Study Record Dates

• First Submitted: April 17, 2014
• First Posted: April 23, 2014
• Study Start: February 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: April 23, 2014

Record last verified: 2014-04

Locations

IN (1)