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Completed

NCT Number: NCT02612792

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

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.

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Key information

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Government Dental College and Research Institute

Bangalore, Karnataka, 560002, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Open Flap Debridement (OFD)

Procedure

Open flap debridement (OFD) alone

OFD with Platelet rich fibrin (PRF)

Procedure

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

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

Procedure

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

Primary outcomes

  1. . Radiographic bone fill assessed in percentage

    Time frame: baseline to 9 months

    assessed in percentage

Secondary outcomes

  1. probing depth measured in mm

    Time frame: baseline to 9 months

    measured in mm

  2. Relative vertical attachment level measured in mm

    Time frame: baseline to 9 months

    measured in mm

  3. Relative horizontal attachment level measured in mm

    Time frame: baseline to 9 months

    measured in mm

  4. modified sulcus bleeding index

    Time frame: baseline to 9 months

    0-3 scale

  5. plaque index

    Time frame: baseline to 9 months

    0-3 scale

Sponsors and collaborators

Lead sponsor

Government Dental College and Research Institute, Bangalore

Other

Registry information

Official study title

Platelet Rich Fibrin Combined With 1.2% Atorvastatin Gel in Treatment of Mandibular Degree II Furcation Defects: a Randomized Controlled Clinical Trial

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 24, 2015
Registry last updated
Nov 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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