The Evaluation of Enamel Matrix Derivative on the Bone Regenerative Potential of the Dental Implant with Transcrestal Sinus Floor Elevation Approach: A Randomized, Parallel-designed CBCT Study.

Abstract

The study aimed to evaluate the clinical and radiographic results of simultaneous implant placements using transcrestal sinus floor elevation (TSFE) with and without enamel matrix derivative (EMD) application. Twenty-four patients were randomly assigned into two groups: EMD+TSFE Group was defined as (n=13 patients, 20 implants) TSFE with EMD application, and TSFE Group was defined as (n=11 patients, 20 implants) TSFE without EMD application. The patients recalled at 3- (T3) and 12- (T12) months after surgery. The residual bone height (RBH), implant protrusion length (IPL), peri-implant sinus bone level (SBL), endo-sinus bone gain (ESBG), and implant stability (ISQ) were measured. Multivariable regressions were performed for the groups. The ESBG was 3.72±0.85 mm in the EMD+TSFE group and, was 3.10±0.05 mm in the TSFE group at T3 and there were statistically significant differences. (p<0.05). However, there were no statistically significant differences in ESBG at T12 between the groups. (p>0.05) ISQ values did not show a statistical difference between the groups at T1 and T3, but in the TSFE+EMD group, it showed a statistical increase at T3 in the intra-group evaluation compared to the TSFE group. In this study, it can be mentioned that the use of EMD in TSFE operations is effective in new bone formation in the apical part of the implant during the early healing period, but in the long term, no significant difference was shown between cases in which EMD was used or not in terms of new bone formation and primary and secondary stabilization. The study was submitted at ClinicalTrials.com; the clinical trial number is ###.