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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-10-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Chronic Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1

Open flap debridement (OFD)

Group Type ACTIVE_COMPARATOR

Open flap debridement (OFD)

Intervention Type PROCEDURE

Oral prophylaxis followed by OFD for treating bone defect

Group 2

OFD with Platelet rich fibrin (PRF)

Group Type ACTIVE_COMPARATOR

OFD with Platelet rich fibrin (PRF)

Intervention Type PROCEDURE

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

Group 3

OFD with PRF and 1.2% Rosuvastatin

Group Type ACTIVE_COMPARATOR

OFD with PRF and 1.2% Rosuvastatin

Intervention Type PROCEDURE

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

Interventions

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Open flap debridement (OFD)

Oral prophylaxis followed by OFD for treating bone defect

Intervention Type PROCEDURE

OFD with Platelet rich fibrin (PRF)

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

Intervention Type PROCEDURE

OFD with PRF and 1.2% Rosuvastatin

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes