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

Study Overview
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Brief Summary
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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.

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

Conditions
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Periodontitis

Intervention / Treatment
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* Procedure: open flap debridement (OFD)
* Other: Platelet rich fibrin (PRF)
* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periodontal Surgery, Periodontal Regeneration, Growth factors, Clinical trials