Two Stage Sinus Lifting Using Nanohydroxyapatite Particles Versus Deproteinized Bovine Bone: Randomized Clinical Trial.

Mahmoud Nour, Mohamed Shawky, Rofaida A Abaas, Maha Hakam, Mohammed Atef
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Abstract

Background: Sinus floor elevation is one of the predictable techniques for augmentation of vertically deficient posterior maxillary alveolar ridges. Several biomaterials were reported to be successful for sinus augmentation, including xenografts and hydroxyapatite. The aim of this study was to compare the quality and quantity of generated bone using xenografts versus nanohydroxyapatite in sinus augmentation.

Methodology: Twenty-four patients/sinuses were randomly assigned into two groups; in the control group, patients underwent sinus floor elevation and augmentation using deproteinized bovine bone (DBB), whereas in the study group, the sinus was augmented using nanohydroxy-apatite bone (NHA). For each patient, the amount of bone height was assessed preoperatively, immediately postoperatively, and 6 months postoperatively. Furthermore, the quality of the newly formed bone was assessed via histological and histomorphometric analyses after 6 months postoperatively.

Results: Both biomaterials showed a good level of consolidation. In the study group, the mean bone height after 6 months was 11.72 ± 1.24 compared to 12.01 ± 1.16 mm in the control group which was not statistically significant (p > 0.05). The mean bone area percent of newly formed bone was 29.84% ± 6.7% for NHA group and 34.73 ± 7.9 for DBB group. Moreover, the mean percent of residual grafting material was 32.43% ± 11.53% for NHA group compared to 30.43% ± 8.27% for DBB group. Histologically, there was no significant difference between both groups regarding different parameters (p > 0.05).

Conclusion: The two-stage sinus floor augmentation using NHA and DBB revealed no statistically significant difference regarding both the quality and the quantity of the regenerated bone. Studies with larger samples and longer follow up are recommended.

Trial registration: ClinicalTrials.gov identifier: NCT03184857.

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使用纳米羟基磷灰石颗粒与去蛋白牛骨的两阶段窦提升术:随机临床试验。
背景:上颌窦底抬高术是一种可预测的上颌后牙槽脊垂直缺损增高技术。据报道,有几种生物材料可成功用于上颌窦增高,包括异种移植物和羟基磷灰石。本研究旨在比较在上颌窦增量术中使用异种移植物和纳米羟基磷灰石生成骨的质量和数量:将 24 名患者/窦随机分为两组:对照组患者使用去蛋白牛骨(DBB)进行窦底抬高和增量,而研究组患者使用纳米羟基磷灰石骨(NHA)进行窦增量。对每位患者的术前、术后即刻和术后 6 个月的骨高度进行了评估。此外,术后 6 个月后,还通过组织学和组织形态计量学分析评估了新形成骨的质量:结果:两种生物材料都显示出良好的巩固性。研究组 6 个月后的平均骨高为(11.72 ± 1.24)毫米,对照组为(12.01 ± 1.16)毫米,差异无统计学意义(P > 0.05)。新形成骨的平均骨面积百分比,NHA 组为 29.84% ± 6.7%,DBB 组为 34.73 ± 7.9%。此外,NHA 组残留移植材料的平均百分比为 32.43% ± 11.53%,而 DBB 组为 30.43% ± 8.27%。从组织学角度看,两组在不同参数上无明显差异(P > 0.05):结论:使用 NHA 和 DBB 进行的两阶段窦底增量术在再生骨的质量和数量方面均无统计学意义上的显著差异。建议进行样本更大、随访时间更长的研究:试验注册:ClinicalTrials.gov identifier:NCT03184857.
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