Digitally Guided Hydraulic Crestal Sinus Floor Elevation Versus Free-Hand Osteotome Technique: A Single-Blinded Randomized Controlled Clinical Trial

数字引导液压上颌窦底提升术与徒手骨凿术的比较:一项单盲随机对照临床试验

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Abstract

OBJECTIVES: To compare the clinical and radiographic outcomes of crestal sinus floor elevation (SFE) using a digital surgical guide (DSG) and hydraulic sinus lift technique versus the conventional osteotome technique. METHODS: Patients requiring crestal SFE and single-implant placement in the posterior maxilla with a minimum of 5 mm of residual bone height were included and randomly assigned to two groups of crestal SFE with (i) the conventional technique (elevation of a mucoperiosteal flap and SFE by the osteotome technique, control group) and (ii) by using a DSG (without flap elevation, by using the sinus lift hydraulic system in the presence of a DSG, test group). Frequency of intraoperative membrane perforation, surgical time, and patient-reported outcomes were collected. Crestal bone loss at 6 months, new bone formation in the sinus, and implant position were assessed. RESULTS: Twenty-three patients (24 implants, 12 in each group) were included. The DSG group experienced significantly lower postoperative pain (measured by the number of analgesics taken, 1.67 ± 0.77 vs. 2.75 ± 1.21, p = 0.028), shorter surgical time (22.3 ± 2.4 vs. 33.1 ± 4.1 min, p < 0.001), and smaller deviation of implant angulation from the ideal position (2.9° ± 0.6° vs. 8.6° ± 1.3°, p < 0.001) compared to the conventional group. The difference in other parameters was not significant. CONCLUSION: Considering the study limitations, using a DSG with a hydraulic system for crestal SFE was superior to the conventional technique regarding pain score, surgical time, and implant angulation. Due to the relatively small sample size and lack of statistically significant differences in some parameters, these findings should be interpreted with caution. TRIAL REGISTRATION: Iranian Registry of Clinical Trials: IRCT20230529058333N1.

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