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Platelet Rich Fibrin+1.2% Atorvastatin in Treatment of Mandibular Degree II Furcation Defects

NCT ID: NCT02612792

Last Updated: 2015-11-24

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

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-08-31

Brief Summary

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The present study was designed to explore the effectiveness of PRF combined with 1.2% ATV gel in treatment of mandibular degree II furcation defects in comparison to PRF and open flap debridement (OFD) alone.

Detailed Description

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Background: A variety of regenerative materials have been tried since many years for the treatment of furcation defects. Platelet-rich fibrin (PRF), a pool reservoir of platelet concentrate with growth factors and Atorvastatin (ATV), a potent member of statin group are known to promote periodontal tissue regeneration. The aim of the present study is to explore the effectiveness of PRF combined with 1.2% ATV gel in treatment of mandibular degree II furcation defects in comparison to PRF and open flap debridement (OFD) alone.

Methods: Eighty two mandibular furcation defects were treated with either OFD alone (Group 1), OFD with PRF (Group 2), and OFD with PRF+1.2% ATV gel (Group 3).Clinical parameters like probing depth (PD), relative vertical clinical attachment level (RVCAL), relative horizontal clinical attachment level (RHCAL), modified sulcus bleeding index (mSBI) and site specific plaque index (PI) were recorded at baseline and 9 months post-operatively. The radiological assessment of bone defect fill was done at baseline and 9 months, using computer-aided software.

Conditions

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Furcation Defects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 1

Scaling and Root Planing (SRP) with Open flap debridement (OFD) alone for treating furcation defect

Group Type ACTIVE_COMPARATOR

Open flap debridement (OFD)

Intervention Type PROCEDURE

Open flap debridement (OFD) alone

Group 2

SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF) for treating furcation defect

Group Type ACTIVE_COMPARATOR

OFD with Platelet rich fibrin (PRF)

Intervention Type PROCEDURE

Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement

Group 3

SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1.2% Atorvastatin for treating furcation defect

Group Type ACTIVE_COMPARATOR

OFD with Platelet rich fibrin (PRF)+1.2% Atorvastatin (Drug) in gel form

Intervention Type PROCEDURE

Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1.2% Atorvastatin gel placement

Interventions

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Open flap debridement (OFD)

Open flap debridement (OFD) alone

Intervention Type PROCEDURE

OFD with Platelet rich fibrin (PRF)

Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement

Intervention Type PROCEDURE

OFD with Platelet rich fibrin (PRF)+1.2% Atorvastatin (Drug) in gel form

Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1.2% Atorvastatin gel placement

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Buccal degree II furcation defects in endodontically vital, asymptomatic mandibular first and second molars with a radiolucency in the furcation area on an intraoral periapical radiograph with probing depth (PD) ≥ 5mm and horizontal ≥ PD 3mm after phase I therapy i.e, scaling and root planing (SRP);
* No history of antibiotic or periodontal therapy in the preceding 6 months.

Exclusion Criteria

* Aggressive periodontitis patients
* Systemic conditions known to affect the periodontal status;
* Medications known to affect the outcomes of periodontal therapy;
* Hematological disorders and insufficient platelet count (\<100,000/mm3);
* Pregnancy/lactation;
* Smoking and tobacco use in any form
* Immunocompromised individuals;
* Those having unacceptable oral hygiene (plaque index \[PI\] \>1.5).
* Teeth with furcation involvement, non-vital teeth, and carious teeth indicated for restorations and mobility of at least grade II were also excluded.
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Government Dental College and Research Institute, Bangalore

OTHER

Sponsor Role lead

Responsible Party

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Dr. A R Pradeep

Professor and Head, Dept of Periodontology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Government Dental College and Research Institute

Bangalore, Karnataka, India

Site Status

Countries

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India

Other Identifiers

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GDCRI/ACM/PG/PhD/2/2013-2014U

Identifier Type: -

Identifier Source: org_study_id