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

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02612792
Enrollment
82
Registered
2015-11-24
Start date
2014-12-31
Completion date
2015-08-31
Last updated
2015-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Furcation Defects

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.

Detailed 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.

Interventions

Open flap debridement (OFD) alone

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

PROCEDUREOFD 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

Sponsors

Government Dental College and Research Institute, Bangalore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
. Radiographic bone fill assessed in percentagebaseline to 9 monthsassessed in percentage

Secondary

MeasureTime frameDescription
probing depth measured in mmbaseline to 9 monthsmeasured in mm
Relative vertical attachment level measured in mmbaseline to 9 monthsmeasured in mm
Relative horizontal attachment level measured in mmbaseline to 9 monthsmeasured in mm
modified sulcus bleeding indexbaseline to 9 months0-3 scale
plaque indexbaseline to 9 months0-3 scale

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026