Platelet-rich Fibrin With 1.2% Rosuvastatin in Chronic Periodontitis Treatment

Chronic Periodontitis Clinical Trial

Official title:

Platelet-rich Fibrin With 1.2% Rosuvastatin for the Treatment of Intrabony Defects in Chronic Periodontitis: A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02645227
• Other study ID #: GDCRI/ACM/PG/PhD/12/2013-14V
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 28, 2015
• Last updated: January 1, 2016
• Start date: January 2015
• Est. completion date: October 2015

Study information

• Verified date: January 2016
• 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 present study is designed to evaluate the combined efficacy of Platelet Rich Fibrin (PRF) and 1.2% Rosuvastatin (RSV) with open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis patients

Description:

ABSTRACT Background: Regenerative periodontal therapy encompasses the use of various bioactive agents that are not only inflammo-modulatory but also osteoclast-inhibitory or rather, osteostimulative. The hypolipidaemic Statin group of drugs, particularly Rosuvastatin (RSV), are known to be associated with alveolar bone formation and periodontal improvements. Platelet analogues like Platelet rich fibrin (PRF), being rich sources of growth factors, have also come into widespread periodontal regenerative use. The aim of the study is to evaluate and compare the efficacy of open-flap debridement (OFD) with or without PRF or PRF + 1.2% RSV gel in the treatment of intrabony defects (IBDs) in chronic periodontitis (CP) patients.

Methods: Ninety individuals with a total of 90 IBDs were randomly assigned to one of the 3 treatment groups: 1) OFD alone, 2) OFD + PRF and 3) OFD + PRF + 1.2% RSV gel placement. Plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), clinical attachment (CA) level and IBD depth were recorded at baseline and at 9 months post-operatively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 45 Years

Eligibility

Inclusion Criteria:

• Systemically healthy with CP diagnosis16 having probing depth (PD) =5mm, clinical attachment (CA) level =3mm and vertical bone loss =3mm on intraoral periapical radiographs (IOPAR) without any antibiotic or periodontal therapy in the last 6 months.

Exclusion Criteria:

• History of statin allergy, statin therapy, any systemic condition or medication altering the periodontal condition, immune-compromised state, hematologic disorders, insuf?cient platelet count (<200,000/mm3), aggressive periodontitis, substance/tobacco abuse and lactating and pregnant females.

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

Intervention

Procedure:
• Open flap debridement (OFD)
Oral prophylaxis followed by OFD for treating bone defect
• OFD with Platelet rich fibrin (PRF)
Oral prophylaxis followed by OFD with PRF placement into the bone defect
• OFD with PRF and 1.2% Rosuvastatin
Oral prophylaxis followed by OFD with PRF and 1.2% Rosuvastatin placement into the bone 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	defect depth reduction (%)	assessed in percentage	Change from baseline to 9 months	No
Secondary	probing depth (mm)	measured in mm	Change from baseline to 9 months	No
Secondary	clinical attachment level (mm)	measured in mm	Change from baseline to 9 months	No
Secondary	modified sulcus bleeding index	scale from 0-3	Change from baseline to 9 months	No
Secondary	plaque index	scale from 0-3	Change from baseline to 9 months	No