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

Phase 2

Completed

Interventions: Procedure: open flap debridement (OFD)
Other: Platelet rich fibrin (PRF)
Drug: Metformin

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
ARM4- open flap debridement plus PRF plus metformin	Metformin	After open flap debridement, PRF and 1% metformin was added into the intrabony defect. No. of subject- 30
ARM4- open flap debridement plus PRF plus metformin	open flap debridement (OFD)	After open flap debridement, PRF and 1% metformin was added into the intrabony defect. No. of subject- 30
ARM2- open flap debridement plus PRF(Platelet rich fibrin)	open flap debridement (OFD)	After open flap debridement, PRF( Platelet rich fibrin) was added into the intrabony defect. No. of subjects= 30
ARM3- open flap debridement plus 1%Metformin	open flap debridement (OFD)	After open flap debridement, 1% metformin was added into the intrabony defect No. of subjects= 30
ARM1- open flap debridement (OFD)	open flap debridement (OFD)	open flap debridement done for 30 subjects. After debridement, Metformin or PRF was not added into the intrabony defect.
ARM2- open flap debridement plus PRF(Platelet rich fibrin)	Platelet rich fibrin (PRF)	After open flap debridement, PRF( Platelet rich fibrin) was added into the intrabony defect. No. of subjects= 30
ARM4- open flap debridement plus PRF plus metformin	Platelet rich fibrin (PRF)	After open flap debridement, PRF and 1% metformin was added into the intrabony defect. No. of subject- 30
ARM3- open flap debridement plus 1%Metformin	Metformin	After open flap debridement, 1% metformin was added into the intrabony defect No. of subjects= 30

Primary Outcome Measures

Name	Time	Method
radiographic defect depth reduction from baseline to 9 months.	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

Secondary Outcome Measures

Name	Time	Method
Change in PD	Assessment of PD at 3,6 and 9 months	PD at 3,6 and 9 months was evaluated by using a UNC-15 probe from the gingival margin to the base of pockrt
Change in RAL	Assessment of RAL at 3,6 and 9 months	RAL is measured by measuring the distance between apical level of customized acrylic stent to pocket base
Cgange in PI	Assessment of PI at 3,6 and 9 months	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
Change in GML	Assessment of GML at 3,6 and 9 months	Assessment of GML is done from apical level of customized acrylic stent, using a UNC 15 periodontal probe
Change in mSBI	Assessment of mSBI at 3,6 and 9 months	mSBI is assessed by noting the amount of bleeding after probing, at 3,6 and 9 months