PRF+1% MF for Class II Mandibular Furcation Defects

July 1, 2017 updated by: Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore

Evaluation of Adjunctive Effect of 1% Metformin To Platelet Rich Fibrin For Mandibular Class II Furcation Defects: A Randomized Controlled Clinical Trial

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.

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Karnataka
      • Bangalore, Karnataka, India, 560002
        • Government Dental College and Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
Scaling and Root Planing (SRP) with Open flap debridement (OFD) alone for treating furcation defect
Open flap debridement (OFD) alone
Active Comparator: Group 2
SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF) for treating furcation defect
Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement
Active Comparator: Group 3
SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1% Metformin for treating furcation defect
Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1.2% Atorvastatin gel placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic bone fill assessed in percentage
Time Frame: baseline to 9 months
assessed in percentage
baseline to 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
probing depth measured in mm
Time Frame: baseline to 9 months
measured in mm
baseline to 9 months
Relative vertical attachment level measured in mm
Time Frame: baseline to 9 months
measured in mm
baseline to 9 months
Relative horizontal attachment level measured in mm
Time Frame: baseline to 9 months
measured in mm
baseline to 9 months
modified sulcus bleeding index
Time Frame: baseline to 9 months
0-3 scale
baseline to 9 months
plaque index
Time Frame: baseline to 9 months
0-3 scale
baseline to 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

July 1, 2017

First Submitted That Met QC Criteria

July 1, 2017

First Posted (Actual)

July 5, 2017

Study Record Updates

Last Update Posted (Actual)

July 5, 2017

Last Update Submitted That Met QC Criteria

July 1, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • GDCRI/ACM/PG/PhD/2/2013-2014KD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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