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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02645227

Enrollment

Registered

2016-01-01

Start date

2015-01-31

Completion date

2015-10-31

Last updated

2016-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Periodontitis

Brief 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

Detailed 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.

Interventions

PROCEDUREOpen flap debridement (OFD)

Oral prophylaxis followed by OFD for treating bone defect

PROCEDUREOFD with Platelet rich fibrin (PRF)

Oral prophylaxis followed by OFD with PRF placement into the bone defect

PROCEDUREOFD with PRF and 1.2% Rosuvastatin

Oral prophylaxis followed by OFD with PRF and 1.2% Rosuvastatin placement into the bone defect

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

25 Years to 45 Years

Healthy volunteers

Yes

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, insufﬁcient platelet count (\<200,000/mm3), aggressive periodontitis, substance/tobacco abuse and lactating and pregnant females.

Design outcomes

Primary

Measure	Time frame	Description
defect depth reduction (%)	Change from baseline to 9 months	assessed in percentage

Secondary

Measure	Time frame	Description
probing depth (mm)	Change from baseline to 9 months	measured in mm
clinical attachment level (mm)	Change from baseline to 9 months	measured in mm
modified sulcus bleeding index	Change from baseline to 9 months	scale from 0-3
plaque index	Change from baseline to 9 months	scale from 0-3

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026