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

Platelet Rich Fibrin With 1% Metformin for the Treatment of Intrabony Defects in Chronic Periodontitis : A Randomized Controlled Clinical Trial

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 Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Drug: Metformin; Procedure: open flap debridement (OFD); Other: Platelet rich fibrin (PRF)

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: ARM1- open flap debridement (OFD); open flap debridement done for 30 subjects. After debridement, Metformin or PRF was not added into the intrabony defect.	Procedure: open flap debridement (OFD)
Experimental: ARM2- open flap debridement plus PRF(Platelet rich fibrin); After open flap debridement, PRF( Platelet rich fibrin) was added into the intrabony defect. No. of subjects= 30	Procedure: open flap debridement (OFD); Other: Platelet rich fibrin (PRF)
Experimental: ARM3- open flap debridement plus 1%Metformin; After open flap debridement, 1% metformin was added into the intrabony defect No. of subjects= 30	Drug: Metformin; Procedure: open flap debridement (OFD)
Experimental: ARM4- open flap debridement plus PRF plus metformin; After open flap debridement, PRF and 1% metformin was added into the intrabony defect. No. of subject- 30	Drug: Metformin; Procedure: open flap debridement (OFD); Other: Platelet rich fibrin (PRF)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	radiographic defect depth reduction from baseline to 9 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	Assessment of PI at 3,6 and 9 months

Collaborators and Investigators

• Sponsor: Government Dental College and Research Institute, Bangalore

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: September 27, 2014
• First Submitted That Met QC Criteria: November 4, 2014
• First Posted (Estimate): November 5, 2014

Study Record Updates

• Last Update Posted (Estimate): November 5, 2014
• Last Update Submitted That Met QC Criteria: November 4, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Clinical trials; Periodontal Regeneration; Growth factors; Periodontal Surgery
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: GDCRI/ACM/PG/PhD/2/2013-2014B