Effect of venous blood, injectable platelet-rich fibrin, and synthetic graft on implant stability following indirect sinus augmentation

AIM: This clinical study evaluated the effects of four different approaches without graft, venous blood, injectable platelet-rich fibrin (i-PRF), and a synthetic graft-on implant stability following indirect sinus augmentation using the Crestal Approach Sinus (CAS) Kit. SETTINGS AND DESIGN: This study was designed as a prospective, randomized, controlled, double-blinded clinical trial conducted among participants with missing maxillary posterior teeth. MATERIALS AND METHODS: Sixty-four participants with a residual bone height of 4-6 mm were randomly allocated into four groups using a computer-generated randomization sequence, with allocation concealment achieved by sequentially numbered, opaque, sealed envelopes. Sixty-four implants were placed using the CAS Kit through a crestal approach. Implant stability was evaluated at baseline and after 6-months using resonance frequency analysis (RFA). Both the outcome assessor and the statistician were blinded to the group assignments. The prospective registration of the trial was completed with the Clinical Trials Registry of India (CTRI/2025/03/081640). Sample de-identification was performed by an independent investigator, and no adverse events were reported. Statistical Analysis used: Statistical evaluation of the data was performed using one-way ANOVA, with Tukey's post hoc test applied for intergroup comparisons. RESULTS: At baseline, all four groups demonstrated comparable ISQ values (P>0.05). At 6 months, Group 3 (i-PRF, ISQ: buccal 70.06 ± 6.31; mesial 74.75 ± 2.52) and Group 4 (synthetic graft, buccal 75.87 ± 2.87; mesial 76.37 ± 2.94) showed significantly greater stability compared to Group 1 (Without graft, buccal 54.81 ± 6.18; mesial 55.75 ± 8.09) and Group 2 (venous blood, buccal 56.75 ± 5.62; mesial 61.50 ± 9.29) (P<0.001). No significant differences were observed between i-PRF and synthetic graft groups (P>0.5). CONCLUSIONS: Indirect sinus augmentation using i-PRF or a synthetic graft significantly enhances implant stability compared to without graft and venous blood groups. i-PRF demonstrated outcomes comparable to the synthetic graft, highlighting its value as a cost-effective alternative in without graft sinus augmentation.