Platelet Rich Fibrin With 1% Metformin Gel for Treatment of Intrabony Defects

Government Dental College and Research Institute, Bangalore120 enrolled

Overview

ABSTRACT: Background: Platelet-rich fibrin (PRF) is a second-generation platelet concentrate which releases various growth factors that promote tissue regeneration. Metformin (MF), a member of biguanide group has been shown to facilitate osteoblast differentiation and thus may exhibit a favourable effect on alveolar bone . Current study was designed to evaluate the combined efficacy of PRF and 1% MF gel with open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis (CP) subjects. Methods: One hundred and twenty subjects with single defects were categorized into four treatment groups: OFD alone, OFD with PRF, OFD with 1% MF and OFD + PRF+1% MF. Clinical parameters like site specific plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), relative attachment level (RAL) and gingival marginal level (GML) were recorded at baseline before surgery and 9 months post-operatively. Percentage radiographic intra-bony defect depth reduction was evaluated using computer-aided software at baseline and 9 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

120

Conditions

Periodontitis

Interventions

Eligibility

Sex: ALLMin age: 30 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Presence of 3- wall intrabony defects ≥3 mm deep (distance between alveolar crest and base of the defect on an intraoral periapical radiograph \[IOPA\] ) along with an interproximal probing depth (PD) ≥5 mm after phase I therapy (scaling and root planing \[SRP\] ) in asymptomatic molar teeth. Exclusion Criteria: * Aggressive Periodontitis subjects * Subjects with systemic conditions known to affect the periodontal status * Medications known to affect the outcomes of periodontal therapy * Hematological disorders and insufficient platelet count (\<200,000/mm3) * Pregnancy/lactation * Smoking and tobacco use in any form * Immunocompromised individuals. Those having unacceptable oral hygiene (plaque index \[PI\]16 \> 1.5) after re-evaluation of Phase I therapy were also excluded from the study. * In addition, teeth with furcation defects, non vital teeth, carious teeth warranting restorations and mobility of at least grade II were also excluded.

Outcomes

Primary Outcomes

radiographic defect depth reduction from baseline to 9 months.

The primary outcome of the study was radiographic defect depth reduction from baseline to 9 months

Time frame: radiographic defect depth reduction from baseline to 9 months.

Secondary Outcomes

Change in PD

PD at 3,6 and 9 months was evaluated by using a UNC-15 probe from the gingival margin to the base of pockrt

Time frame: Assessment of PD at 3,6 and 9 months

Change in RAL

RAL is measured by measuring the distance between apical level of customized acrylic stent to pocket base

Time frame: Assessment of RAL at 3,6 and 9 months

Change in GML

Assessment of GML is done from apical level of customized acrylic stent, using a UNC 15 periodontal probe

Time frame: Assessment of GML at 3,6 and 9 months

Change in mSBI

mSBI is assessed by noting the amount of bleeding after probing, at 3,6 and 9 months

Time frame: Assessment of mSBI at 3,6 and 9 months

Cgange in PI

PI is assessed by noting the amount of plaque and the site of plaque present on the tooth surface at 3,6 and 9 months

Time frame: Assessment of PI at 3,6 and 9 months