Comparative Clinical and Radiographic Evaluation of Efficacy of G-BONE™ (Hydroxyapatite and Beta Tricalcium Phosphate) Versus G-BONE™ (Hydroxyapatite and Beta Tricalcium Phosphate) with Advanced Platelet Rich Fibrin in the Treatment of Intrabony Defects in Chronic Periodontitis Patients – A Randomized Clinical Trial

Introduction

Periodontal disease is a chronic inflammatory condition that forms pathological pockets around affected teeth, leading to the loss of connective tissue and alveolar bone. Exposure to dental plaque and biofilms results in bacterial buildup, often starting as gingivitis and progressing to periodontitis. Treatment aims to restore damaged tissues, with periodontal regeneration involving the growth of new alveolar bone, cementum, and periodontal ligaments using various bone grafts like autografts, allografts, xenografts, and synthetic grafts. Calcium phosphate bone grafts, such as hydroxyapatite (HA) and tricalcium phosphate (TCP), meet the requirements for synthetic biomaterials due to their nontoxic and stable nature. PRF, introduced in 2001, and its advanced form A-PRF, developed in 2014, have shown significant effectiveness in tissue regeneration, releasing growth factors like PDGF, TGF-β and VEGF. A-PRF, with higher leukocyte and platelet concentrations, enhances fibroblast migration and collagen production, offering sustained cytokine release. When combined with bone grafts, A-PRF promotes greater bone fill and attachment gain. The study aims to compare the bone fill in human intrabony defects using G-BONEâ„¢ (a combination of hydroxyapatite and beta-tricalcium phosphate) with Advanced platelet rich fibrin, focusing on patients with chronic periodontitis to evaluate the effectiveness of these treatments in bone regeneration.

Aims & Objectives

To evaluate and compare clinically and radiographically efficacy of G-BONEâ„¢ (Hydroxyapatite and Beta Tricalcium Phosphate) Versus G-BONEâ„¢  (Hydroxyapatite and Beta Tricalcium Phosphate) with Advanced Platelet Rich Fibrin in the Treatment of Intrabony Defects in Chronic Periodontitis Patients.

Materials and Methods

Fourty two intrabony defects were randomly two different groups and were treated with group A G-BONEâ„¢ (Hydroxyapatite and Beta Tricalcium Phosphate) and group B G-BONEâ„¢  (Hydroxyapatite and Beta Tricalcium Phosphate) with Advanced Platelet Rich Fibrin in the Treatment of Intrabony Defects in Chronic Periodontitis Patients  Clinical parameters such as plaque index (PI),gingival index (GI), pocket probing depth (PPD), clinical attachment level (CAL) were assessed at baseline 1 month, 3 month and 6 month Postoperatively y; radiographic parameter such as percentage in bone fill (%BF) were calculated by using the computerized image analysis software. Data collected will be compiled on to a MS Office excel worksheet & will be subjected to statistical analysis using an appropriate package like SPSS software. Normality of numerical data will be checked using Shapiro – Wilk test or Kolmogorov-Smirnov test. Depending on the normality of data, statistical tests will be determined.  For a numerical continuous data following a normal distribution, inter group comparison (2 groups) will be done using t test, else a non-parametric substitute like Mann Whitney U test will be used. Descriptive statistics like frequency (n) & percentage (%) of categorical data, mean & Standard deviation of numerical data in each group will be depicted & may be compared using chi square test.Intra group comparisons for a numerical continuous data following a normal distribution will be done using paired t test (for 2 observations) or repeated measures ANOVA for >2 observations, else a non-parametric substitute like Wilcoxon signed rank test (for 2 observations) or Friedman’s test for >2 observations will be used. Keeping alpha error at 5% and Beta error at 20%, power at 80%, p<0.05 will be considered statistically significant.