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

G

Government Dental College and Research Institute, Bangalore

Status and phase

Completed
Phase 3
Phase 2

Conditions

Furcation Defects

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02612792
GDCRI/ACM/PG/PhD/2/2013-2014U

Details and patient eligibility

About

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.

Full 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.

Enrollment

82 patients

Sex

All

Ages

30 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

82 participants in 3 patient groups

Group 1
Active Comparator group
Description:
Scaling and Root Planing (SRP) with Open flap debridement (OFD) alone for treating furcation defect
Treatment:
Procedure: Open flap debridement (OFD)
Group 2
Active Comparator group
Description:
SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF) for treating furcation defect
Treatment:
Procedure: OFD with Platelet rich fibrin (PRF)
Group 3
Active Comparator group
Description:
SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1.2% Atorvastatin for treating furcation defect
Treatment:
Procedure: OFD with Platelet rich fibrin (PRF)+1.2% Atorvastatin (Drug) in gel form

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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