4th Division, Peking University School and Hospital of Stomatology, Beijing, China.
Orthodontic Department, Peking University School and Hospital of Stomatology, Beijing, China.
Clin Implant Dent Relat Res. 2023 Oct;25(5):967-973. doi: 10.1111/cid.13225. Epub 2023 May 22.
To compare clinical and histological outcomes of sinus augmentation performed immediately or 3 months after pseudocyst removal through a prospective randomized controlled study.
In total, 33 sinus augmentation procedures were performed in 31 patients. Augmentation was performed either immediately after pseudocyst removal (one-stage intervention) or after 3 months (two-stage intervention). Six months postoperatively, bone specimens were harvested, and histomorphometric analysis was performed as primary outcome. Data were recorded and evaluated for implant survival rates, marginal bone resorption, complication rate, and patient-centered outcomes (visual analogue scale [VAS]).
There were no baseline differences between groups or dropouts. Twelve biopsies obtained for histomorphometric analysis showed that delayed sinus augmentation, when compared to immediated led to a 1.1% increased mineralized bone ratio (95% confidence interval [CI]: -15.9 to 13.7). Graft leakage and acute sinusitis occurred in one patient in the one-stage group, none in the two-stage group. No pseudocyst recurrence was observed until the end of 1-year follow-up. Median VAS scores for overall acceptance were significantly increase of 1.4 (95% CI: 0.3-2.56) in immediate group. The degree of post-operative discomfort was not significantly different, although an increase of VAS (0.52, 95% CI: -0.32 to 1.37) was observed in delay group.
Both procedures of sinus augmentation immediately and 3 months after pseudocyst removal could obtain comparable histological outcomes and had low complication rates. Patients who underwent the one-stage procedure had a short treatment course and high satisfaction rates, but this procedure is technically challenging to perform. This clinical trial was not registered prior to participant recruitment and randomization. The clinical trial registration number is ChiCTR2200063121. The hyperlink is as follows: https://www.chictr.org.cn/showproj.html?proj=172755.
通过前瞻性随机对照研究比较即刻和假性囊肿去除后 3 个月行鼻窦提升术的临床和组织学结果。
共 31 名患者接受了 33 例鼻窦提升术。提升术在假性囊肿去除后即刻（一期干预）或 3 个月后（二期干预）进行。术后 6 个月，采集骨标本，进行组织形态计量学分析作为主要结果。记录并评估了种植体存活率、边缘骨吸收、并发症发生率和以患者为中心的结果（视觉模拟评分 [VAS]）。
两组之间或脱落患者之间没有基线差异。12 例用于组织形态计量学分析的活检显示，与即刻鼻窦提升相比，延迟鼻窦提升导致矿化骨比例增加 1.1%（95%置信区间 [CI]：-15.9 至 13.7）。一期组有 1 例患者发生移植体渗漏和急性鼻窦炎，二期组无此类并发症。在 1 年随访结束时，未观察到假性囊肿复发。即刻组总体接受度的 VAS 评分中位数显著增加 1.4（95% CI：0.3-2.56）。延迟组的 VAS 评分（0.52，95% CI：-0.32 至 1.37）虽有增加，但术后不适程度并无显著差异。
即刻和假性囊肿去除后 3 个月行鼻窦提升术均可获得相似的组织学结果，且并发症发生率较低。一期手术的患者治疗过程较短，满意度较高，但该手术操作技术具有挑战性。本临床试验在招募和随机分组前未进行注册。临床试验注册号为 ChiCTR2200063121。链接如下：https://www.chictr.org.cn/showproj.html?proj=172755.
