自体骨与含25%自体骨的牛骨矿物质用于上颌窦底提升术的比较：一项为期1年的多中心、双侧对照、随机对照试验
Maxillary Sinus Floor Augmentation With Autogenous Bone Versus Bovine Bone Mineral Mixed With 25% Autogenous Bone: A 1-Year Multicenter, Split-Mouth, Randomized Controlled Trial.
作者信息
Jue Anouck, Pijpe Justin, Wolvius Eppo, Naenni Nadja, Strauss Franz J, Jonker Brend
机构信息
Department of Oral & Maxillofacial Surgery, Special Dental Care and Orthodontics, Erasmus Medical Center, Rotterdam, the Netherlands.
Department of Oral & Maxillofacial Surgery, Catharina Hospital, Eindhoven, the Netherlands.
出版信息
Clin Oral Implants Res. 2025 Jul;36(7):859-870. doi: 10.1111/clr.14431. Epub 2025 Mar 17.
OBJECTIVES
To compare autogenous bone (AB) harvested from the mandibular ramus or a mixture of bovine bone mineral (BBM) with 25% locally harvested autogenous bone chips from the maxilla for maxillary sinus floor augmentation (MSFA).
MATERIAL AND METHODS
Patients requiring bilateral MSFA and implant placement were enrolled in this study. Maxillary sinuses were randomly assigned (1:1) to one of the two groups: MSFA + AB (AB group) or MSFA + AB + BBM (BBM group). AB was harvested from the mandible (AB group) or locally during MSFA (BBM group). Implants were placed after 4-6 months of healing and loaded 4-6 months later. Patients were examined at baseline (1 month post-loading) and 12 months post-loading. Outcome measures included clinician- and patient-reported outcomes.
RESULTS
Fifty patients with 198 implants were included (AB = 99, BBM = 99). Twelve implants failed before loading (AB = 6, BBM = 6), and three failed post-loading (AB = 2, BBM = 1). Implant survival was 92.9% (AB group) and 93.9% (BBM group) at 12 months post-loading, with no significant differences between the groups (HR, 0.85; 95% CI, 0.28-2.54; p = 0.770). Implant success was 98.8% (AB group) and 97.6% (BBM group), with no significant differences between the groups (HR, 0.49; 95% CI, 0.03-8.05; p = 0.620). No significant differences in marginal bone loss or clinical parameters were found between groups (p > 0.05). Patient satisfaction significantly improved at follow-ups compared to screening (p = 0.005).
CONCLUSION
Implants placed after MSFA with AB or BBM showed comparable results. This indicates that MSFA can be successfully performed without requiring AB from an additional donor site, potentially reducing patient morbidity.
TRIAL REGISTRATION
This study was registered in the Dutch Trial Register with number NL59578.078.16 on 09-05-2017. The study start date was on 21-08-2017.
目的
比较从下颌升支获取的自体骨（AB）或牛骨矿物质（BBM）与25%上颌局部获取的自体骨屑用于上颌窦底提升术（MSFA）的效果。
材料与方法
本研究纳入需要双侧MSFA及种植体植入的患者。上颌窦随机（1:1）分为两组：MSFA + AB组（AB组）或MSFA + AB + BBM组（BBM组）。AB取自下颌骨（AB组）或在MSFA术中局部获取（BBM组）。愈合4 - 6个月后植入种植体，4 - 6个月后进行加载。在基线期（加载后1个月）和加载后12个月对患者进行检查。观察指标包括临床医生和患者报告的结果。
结果
纳入50例患者共198颗种植体（AB组99颗，BBM组99颗）。12颗种植体在加载前失败（AB组6颗，BBM组6颗），3颗在加载后失败（AB组2颗，BBM组1颗）。加载后12个月时，AB组种植体存留率为92.9%，BBM组为93.9%，两组间无显著差异（风险比，0.85；95%可信区间，0.28 - 2.54；p = 0.770）。AB组种植体成功率为98.8%，BBM组为97.6%，两组间无显著差异（风险比，0.49；95%可信区间，0.03 - 8.05；p = 0.620）。两组间在边缘骨吸收或临床参数方面无显著差异（p > 0.05）。与筛查时相比，随访时患者满意度显著提高（p = 0.005）。
结论
MSFA术后植入AB或BBM的种植体效果相当。这表明MSFA无需额外供区的AB即可成功实施，可能降低患者的发病率。
试验注册
本研究于2017年5月9日在荷兰试验注册中心注册，注册号为NL59578.078.16。研究开始日期为2017年8月21日。
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