PRF+1% MF for Class II Mandibular Furcation Defects

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

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-05-31

Brief Summary

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The aim of the present trial is to evaluate the efficacy of PRF with 1% MF in treatment of mandibular class II furcation defects and its comparison to PRF and access therapy alone.

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Detailed Description

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Background: For improving efﬁcacy and outcomes of regenerative therapy for furcation defects, various materials has been investigated in addition to access therapy. Platelet-rich fibrin (PRF) having concentrated growth factors and cytokines and Metformin (MF), an efficacious member of biguanide group are known to enhance periodontal regeneration. The aim of the present trial is to evaluate the efficacy of PRF with 1% MF in treatment of mandibular class II furcation defects and its comparison to PRF and access therapy alone.

Methods: This randomized trial was conducted on 75 patients with mandibular class II furcation defects. Defects were surgically treated with either access therapy alone (Group 1), access therapy+PRF (Group 2), and access therapy+ PRF+1% MF (Group 3). Clinical parameters like probing depth (PD), relative clinical attachment level {vertical (RVCAL) and horizontal (RHCAL)}, modified sulcus bleeding index (mSBI) and site specific plaque index (PI) were evaluated at baseline and 9 months post-operatively. Radiological assessment of bone defect fill was done at baseline and 9 months.

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

TRIPLE

Participants Investigators Outcome Assessors

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% Metformin for treating furcation defect

Group Type ACTIVE_COMPARATOR

OFD with Platelet rich fibrin (PRF)+1% Metformin (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% Metformin (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