Comparative Clinical and Radiographic Evaluation of Efficacy of G-Graft™ (Hydroxyapatite with Collagen) Versus G-Graft™ (Hydroxyapatite with Collagen) with Injectable Platelet Rich Fibrin in the Treatment of Intrabony Defects in Chronic Periodontitis Patients – A Randomized Clinical Trial

Aims and Objectives:

Comparative Clinical and Radiographic Evaluation of Efficacy of G-Graftâ„¢ (Hydroxyapatite with Collagen) Versus G-Graftâ„¢ (Hydroxyapatite with Collagen) with Injectable Platelet Rich Fibrin in the Treatment of Intrabony Defects in Chronic Periodontitis Patients.

Introduction:

Periodontium is a specialized tissue that surrounds and supports the teeth in the jaws. Periodontium may be affected by microorganisms along with the host response, resulting in destruction of the periodontal ligament and alveolar bone. Bone is a dynamic organ that can regenerate and bone grafting is a dynamic phenomenon. Collagen is an osteo inductive material due to its osteoconductive property when it is used in combination with osteoconductive carriers like hydroxyapatite or tricalcium phosphate. The injectable platelet rich fibrin is a newly researched or developed leucocyte-enriched platelet-rich concentrate that has been observed to have better antibacterial action against a variety of periodontal infections, as well as the ability to generate increased fibroblast migration and the production of high levels of growth factor.

The purpose of this study is to compare the bone fill of human intrabony defect grafted with G-Graftâ„¢ (Hydroxyapatite with Collagen) and with G-Graftâ„¢ (Hydroxyapatite with Collagen) with Injectable Platelet Rich Fibrin in the treatment of Intrabony Defects in Chronic Periodontitis.

Materials and Method:

The patients selected as per the inclusion and exclusion criteria, will be randomly allotted by a computerized automated randomization method into 2 groups, Group A and Group B, each consisting of 20 patients and treated as follows

Group A : Open flap debridement, followed by placement of  G-Graftâ„¢ (Hydroxyapatite with Collagen)

Group B : Open flap debridement, followed by placement of G-Graftâ„¢ (Hydroxyapatite with Collagen)  with Injectable Platelet Rich Fibrin

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; 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.