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

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

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Three Wall Intrabony Defects in 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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PRF and SMV Group

sites treated with Open Flap Debridement with Platelet Rich Fibrin along with Simvastatin

Group Type ACTIVE_COMPARATOR

Platelet rich fibrin and simvastatin

Intervention Type DRUG

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.

PRF Group

sites treated with Open Flap Debridement with autologous Platelet Rich Fibrin

Group Type SHAM_COMPARATOR

Platelet rich fibrin

Intervention Type BIOLOGICAL

Three wall intrabony defect sites treated with Open Flap Debridement. PRF was placed into the intrabony defect.

OFD Group

sites treated with Open Flap Debridement i.e. conventional flap surgery

Group Type OTHER

Open Flap Debridement alone

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type DRUG

Platelet rich fibrin

Three wall intrabony defect sites treated with Open Flap Debridement. PRF was placed into the intrabony defect.

Intervention Type BIOLOGICAL

Open Flap Debridement alone

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes