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

NCT02612792 | Completed Phase 2

• 1 other identifier: GDCRI/ACM/PG/PhD/2/2013-2014U
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Furcation Defects

Outcome Measures

Primary Outcomes (1)

• . Radiographic bone fill assessed in percentage

  assessed in percentage

  baseline to 9 months

Secondary Outcomes (5)

• probing depth measured in mm

  baseline to 9 months

• Relative vertical attachment level measured in mm

  baseline to 9 months

• Relative horizontal attachment level measured in mm

  baseline to 9 months

• modified sulcus bleeding index

  baseline to 9 months

• plaque index

  baseline to 9 months

Study Arms (3)

Group 1

ACTIVE COMPARATOR

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

Procedure: Open flap debridement (OFD)

Group 2

ACTIVE COMPARATOR

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

Procedure: OFD with Platelet rich fibrin (PRF)

Group 3

ACTIVE COMPARATOR

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

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

Interventions

Open flap debridement (OFD) PROCEDURE

Open flap debridement (OFD) alone

Group 1

OFD with Platelet rich fibrin (PRF) PROCEDURE

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

Group 2

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

Group 3

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Government Dental College and Research Institute, Bangalore: lead

Study Sites (1)

Government Dental College and Research Institute

Bangalore, Karnataka, 560002, India

Location

MeSH Terms

Conditions

Furcation Defects

Interventions

Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head, Dept of Periodontology

Study Record Dates

• First Submitted: November 20, 2015
• First Posted: November 24, 2015
• Study Start: December 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: November 24, 2015

Record last verified: 2015-11

Locations

IN (1)