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

Furcation Defects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02612792
• Other study ID #: GDCRI/ACM/PG/PhD/2/2013-2014U
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 20, 2015
• Last updated: November 23, 2015
• Start date: December 2014
• Est. completion date: August 2015

Study information

• Verified date: November 2015
• Source: Government Dental College and Research Institute, Bangalore
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Furcation Defects

Intervention

Procedure:
• Open flap debridement (OFD)
Open flap debridement (OFD) alone
• OFD with Platelet rich fibrin (PRF)
Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement
• 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

Locations

Country	Name	City	State
India	Government Dental College and Research Institute	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Government Dental College and Research Institute, Bangalore

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	. Radiographic bone fill assessed in percentage	assessed in percentage	baseline to 9 months	No
Secondary	probing depth measured in mm	measured in mm	baseline to 9 months	No
Secondary	Relative vertical attachment level measured in mm	measured in mm	baseline to 9 months	No
Secondary	Relative horizontal attachment level measured in mm	measured in mm	baseline to 9 months	No
Secondary	modified sulcus bleeding index	0-3 scale	baseline to 9 months	No
Secondary	plaque index	0-3 scale	baseline to 9 months	No