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Objective <p>The aim of this study was to evaluate the effectiveness of two different species of deproteinized bovine bone minerals (DBBM) in lateral window sinus floor elevation (LSFE).</p> Methods <p>Thirty-six patients underwent LSFE were included in this randomized controlled clinical trial and randomly divided into two groups using two kinds of bone substitution materials, low-temperature sintered DBBM (LT-DBBM) or high-temperature sintered DBBM (HT-DBBM). Cone-beam computed tomography (CBCT) was acquired before, immediate post-operation and 6 months post-operation. Bone columns were obtained during first-stage implant surgery. The effect of the materials in each group was investigated by analyzing bone height and bone volume according to CBCT. New bone formation was evaluated by analyzing Micro-CT and slice of bone column.</p> Results <p>Thirty-six patients were included in this pilot study (20 patients in LT-DBBM and 16 patients in HT-DBBM group). The bone height gain at 6 months postoperatively was 11.28 ± 0.46&#xa0;mm in LT-DBBM and 11.41 ± 0.55&#xa0;mm in HT-DBBM group and, exhibited no statistically significant difference. The vertical heights altered after 6 months in two groups with − 0.96 ± 0.21&#xa0;mm in LT-DBBM group and − 1.05 ± 0.28&#xa0;mm in HT-DBBM group. When comparing the volume change, the DBBM resorption rates were 8.32 ± 3.02% in LT-DBBM group and 10.44 ± 4.63% in HT-DBBM group. The results of the micro-CT analysis were comparative between the two groups, Bone volume fraction (BV/TV) values were 13.21 ± 2.75% and 13.92 ± 3.07%, trabecular thickness (Tb.Th) were 0.044 ± 0.008&#xa0;mm and 0.061 ± 0.011&#xa0;mm, trabecular number (Tb.N) were 4.76 ± 1.52 and 3.52 ± 1.31, and trabecular separation (Tb.Sp) were 0.41 ± 0.10 and 0.40 ± 0.08 for LT-DBBM and HT-DBBM group respectively. Histologic sections in both groups presented newly formed mature bone and blood vessels around bone particles.</p> Conclusion <p>In this pilot study, no significant differences were found between LT-DBBM and HT-DBBM in terms of bone height gain, graft resorption, or new bone formation at 6 months. These preliminary findings suggest that both materials are viable for LSFE. However, larger, adequately powered studies are required to confirm these results and establish definitive clinical equivalence.</p> Trial registration <p>The project has been registered at <a href="https://www.chictr.org.cn/">https://www.chictr.org.cn/</a> with the approval number ChiCTR2300073635, registration date 17th July 2023.</p>

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A pilot study of the effect of two deproteinized bovine bone minerals in lateral window sinus floor elevation

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  • 发表日期：

    2026年6月1日

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  • Yun Qiu,
  • Shimin Yu,
  • Ting Xia,
  • Hao Zeng,
  • Yufeng Zhang,
  • Qihang Fan,
  • Yan Wei

摘要

Objective

The aim of this study was to evaluate the effectiveness of two different species of deproteinized bovine bone minerals (DBBM) in lateral window sinus floor elevation (LSFE).

Methods

Thirty-six patients underwent LSFE were included in this randomized controlled clinical trial and randomly divided into two groups using two kinds of bone substitution materials, low-temperature sintered DBBM (LT-DBBM) or high-temperature sintered DBBM (HT-DBBM). Cone-beam computed tomography (CBCT) was acquired before, immediate post-operation and 6 months post-operation. Bone columns were obtained during first-stage implant surgery. The effect of the materials in each group was investigated by analyzing bone height and bone volume according to CBCT. New bone formation was evaluated by analyzing Micro-CT and slice of bone column.

Results

Thirty-six patients were included in this pilot study (20 patients in LT-DBBM and 16 patients in HT-DBBM group). The bone height gain at 6 months postoperatively was 11.28 ± 0.46 mm in LT-DBBM and 11.41 ± 0.55 mm in HT-DBBM group and, exhibited no statistically significant difference. The vertical heights altered after 6 months in two groups with − 0.96 ± 0.21 mm in LT-DBBM group and − 1.05 ± 0.28 mm in HT-DBBM group. When comparing the volume change, the DBBM resorption rates were 8.32 ± 3.02% in LT-DBBM group and 10.44 ± 4.63% in HT-DBBM group. The results of the micro-CT analysis were comparative between the two groups, Bone volume fraction (BV/TV) values were 13.21 ± 2.75% and 13.92 ± 3.07%, trabecular thickness (Tb.Th) were 0.044 ± 0.008 mm and 0.061 ± 0.011 mm, trabecular number (Tb.N) were 4.76 ± 1.52 and 3.52 ± 1.31, and trabecular separation (Tb.Sp) were 0.41 ± 0.10 and 0.40 ± 0.08 for LT-DBBM and HT-DBBM group respectively. Histologic sections in both groups presented newly formed mature bone and blood vessels around bone particles.

Conclusion

In this pilot study, no significant differences were found between LT-DBBM and HT-DBBM in terms of bone height gain, graft resorption, or new bone formation at 6 months. These preliminary findings suggest that both materials are viable for LSFE. However, larger, adequately powered studies are required to confirm these results and establish definitive clinical equivalence.

Trial registration

The project has been registered at https://www.chictr.org.cn/ with the approval number ChiCTR2300073635, registration date 17th July 2023.