Evaluation of Grape Seed Formulation as an Adjunct to Scaling and Root Planing on Oxidative Stress, Inflammatory Status and Glycaemic Control in Type 2 Diabetic Patients with Chronic Periodontitis: A Randomised Controlled Trial

Introduction: Nutraceuticals are food derived products that provide health benefits, in addition to basic nutritional value of the food. Grape Seed Extracts (GSE) contain a high concentration of proanthocyanidin which is known to possess strongest antioxidant property. Control and modulation of Reactive Oxygen Species (ROS) activity is normally achieved by synthesis and accumulation of antioxidants. Increased ROS production due to oxidative stress results in hyperinflammatory state and worsens the glycaemic status in diabetic patients with chronic periodontitis. Aim: The aim of the present study was to evaluate the effect of grape seed formulation as an adjunct to scaling and root planing (SRP) on oxidative stress, inflammatory status and glycaemic control in type 2 diabetic patients with chronic periodontitis. Materials and Methods: This was a double blind randomised clinical trial where 48 diabetic patients with chronic periodontitis were selected from the Outpatient Department of Periodontology, JSS Dental College, Mysore, Karnataka, India. The duration of the study was 10 months. Patients were randomly divided into two groups of 24 each: test group (SRP+grape seed formulation) and control group (SRP+placebo) which was given once daily for two months. Clinical parameters such as Plaque Index (PI), Gingival Index (GI), Pocket Probing Depth (PPD) and Clinical Attachment Level (CAL); metabolic parameters such as glycated Hb (HbA1c), Fasting Blood Sugar (FBS) was carried out at baseline, 3 months and 6 months. Also, inflammatory marker i.e., Myeloperoxidase (MPO) was estimated from Gingival Crevicular Fluid (GCF) and Total Antioxidant Capacity (TAOC) were recorded at baseline, 3 months and 6 months. Statistical Package for the Social Sciences (SPSS) version 16 was used for all statistical analysis. Intergroup and intragroup comparisons for both test and control group were analysed by paired t-test and independent t-test, respectively. A p-value ≤0.05 was considered as statistically significant. Results: Intergroup comparison showed that there was no significant difference in PI, Sulcular Bleeding Index (SBI), CAL, PD between the test and control group at baseline, 3 months and 6 months except SBI scores at 3 months with p-value=0.017 and PI scores with p-value=0.014. The test group (SRP+GSE) as well as control group (SRP+placebo) showed statistically significant improvement from baseline to 3 months and baseline to 6 months in PI, SBI, CAL and PD (p≤0.05). FBS showed significant improvement from baseline to 3 months in both test and the control group.At 3 months statistically significant results was seen in SBI, FBS, TAOC, MPO and PI scores between the test and the control group (p≤0.05). Conclusion: This study shows a promising result in using grape seed formulation as an adjunct to scaling and root planing to reduce the oxidative stress, decreasing the inflammation and achieving the glycaemic control in diabetic patients with chronic periodontitis. Further studies are needed to prove its efficacy as an adjunct to conventional therapy.