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

Three Wall Intrabony Defects in Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02120872
• Other study ID #: GDCRI/ACM/PG/PhD/2011-2012/E
• Status: Completed
• Phase: Phase 2
• First received: April 17, 2014
• Last updated: April 19, 2014
• Start date: February 2013
• Est. completion date: January 2014

Study information

• Verified date: April 2014
• Source: Government Dental College and Research Institute, Bangalore
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis
• Three Wall Intrabony Defects in Chronic Periodontitis

Intervention

Drug:
• Platelet rich fibrin and simvastatin
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.

Biological:
• Platelet rich fibrin
Three wall intrabony defect sites treated with Open Flap Debridement. PRF was placed into the intrabony defect.

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

Locations

Country	Name	City	State
India	Government Dental College and Research Institute	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Government Dental College and Research Institute, Bangalore

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure of the study was defect depth reduction evaluated radiographically		At baseline and 9 month after surgery	No
Secondary	Probing Depth		At baseline and 9 month after surgery	No
Secondary	Relative Attachment Level		At baseline and 9 month after syrgery	No
Secondary	modified Sulcul Bleeding Index		At baseline and 9 month after surgery	No
Secondary	Plaque Index		At baseline and 9 month after surgery	No