ASSESSMENT OF BONE DENSITY & GINGIVAL CREVICULAR FLUID DERIVED BONE BIOMARKER (OSTEOCALCIN) IN BONE LEVEL & TISSUE LEVEL IMPLANTS: A RANDOMIZED CONTROL TRIAL

Abstract

Background: Immediate loading protocols in dental implantology have gained popularity due to reduced treatment time and improved patient satisfaction. However, the influence of implant design—particularly bone-level and tissue-level implants—on early osseointegration and peri-implant bone response remains insufficiently explored. The use of biochemical markers such as Osteocalcin, along with radiographic assessment using Cone Beam Computed Tomography, provides a comprehensive evaluation of peri-implant bone dynamics. Aim: To compare peri-implant bone density and osteocalcin levels in gingival crevicular fluid around bone-level and tissue-level implants subjected to immediate non-functional loading. Materials and Methods: A prospective randomized controlled split-mouth clinical trial was conducted on 30 patients (60 implant sites). Each patient received one bone-level implant (Group I) and one tissue-level implant (Group II). Immediate non-functional loading was performed within 48 hours. Osteocalcin levels were assessed at 2 weeks and 3 months using ELISA. Bone density (Hounsfield Units) and marginal bone loss were evaluated using CBCT. Statistical analysis was performed using SPSS version 21.0 with significance set at p < 0.05. Results: At 2 weeks, osteocalcin levels and bone density were comparable between groups (p > 0.05). At 3 months, Group I demonstrated significantly higher osteocalcin levels (3.081 ± 0.259 ng/mL vs. 2.912 ± 0.134 ng/mL; p = 0.002) and greater bone density (619.90 ± 39.21 HU vs. 590.37 ± 49.17 HU; p = 0.013). Both groups showed significant intragroup increases over time (p < 0.001). Marginal bone loss was minimal and comparable between groups (p > 0.05). Conclusion: Immediate non-functional loading is a reliable and predictable protocol for both implant designs. Bone-level implants demonstrated superior early biological and radiographic outcomes, indicating enhanced osseointegration. However, both implant types maintained excellent marginal bone stability.