Platelet - Rich Fibrin Combined With 1.2mg Simvastatin for the Treatment of 3 - Wall Intrabony Defects in Chronic Periodontitis: A Randomized Controlled Clinical Trial
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
sites treated with Open Flap Debridement with Platelet Rich Fibrin along with Simvastatin
Intervention: Platelet rich fibrin and simvastatin (Drug)
PRF Group
sites treated with Open Flap Debridement with autologous Platelet Rich Fibrin
Intervention: Platelet rich fibrin (Biological)
OFD Group
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
Dr. A R Pradeep
Professor and Head of Department
Government Dental College and Research Institute, Bangalore