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Clinical Trials/NCT02120872
NCT02120872CompletedPhase 2

Platelet - Rich Fibrin Combined With 1.2mg Simvastatin for the Treatment of 3 - Wall Intrabony Defects in Chronic Periodontitis: A Randomized Controlled Clinical Trial

Government Dental College and Research Institute, Bangalore1 site in 1 country90 target enrollmentStarted: February 2013Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
90
Locations
1
Primary Endpoint
The primary outcome measure of the study was defect depth reduction evaluated radiographically

Study Overview

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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
25 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

PRF and SMV Group

Active Comparator

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

Intervention: Platelet rich fibrin and simvastatin (Drug)

PRF Group

Sham Comparator

sites treated with Open Flap Debridement with autologous Platelet Rich Fibrin

Intervention: Platelet rich fibrin (Biological)

OFD Group

Other

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

Intervention: Open Flap Debridement alone (Procedure)

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

  • Plaque Index(At baseline and 9 month after surgery)
  • 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)

Investigators

Sponsor
Government Dental College and Research Institute, Bangalore
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr. A R Pradeep

Professor and Head of Department

Government Dental College and Research Institute, Bangalore

Study Sites (1)

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