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可塑形颗粒状骨材料用于牙槽嵴保存的多中心随机对照试验

Moldable and Particulate Bone Material in Alveolar Ridge Preservation: A Multicenter Randomized Controlled Trial.

作者信息

Choi Yiseul, Cheong Jieun, Song Yoolbin, Kim Jaeyeon, Kang Dae-Young, Ahn Hyeon-Seong, Park Sanghoon, Esposito Marco, Shin Hyun-Seung, Park Wonse

机构信息

Department of Advanced General Dentistry, Yonsei University College of Dentistry, Seoul, Korea.

Institute for Innovation in Digital Healthcare, Yonsei University, Seoul, Korea.

出版信息

Clin Implant Dent Relat Res. 2025 Apr;27(2):e70011. doi: 10.1111/cid.70011.

DOI:10.1111/cid.70011
PMID:40070028
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11951245/
Abstract

INTRODUCTION

This study aimed to determine possible histological and radiological differences in alveolar ridge preservation (ARP), using moldable bone versus particulate bone.

METHODS

After tooth extraction, 39 patients (40 teeth) were randomized (1:1) to receive ARP using moldable bone materials (SBX group) or particulate bone materials (PBX group). An absorbable collagen membrane was placed over the graft material and the surgical site was sutured. Cone-beam computed tomography was taken immediately and 5 months after ARP. Bone core samples from the implantation site were obtained for histomorphometric analysis 5 months after ARP.

RESULTS

Forty-six patients were screened and 39 of them completed the study. However, one patient who received split-mouth treatment was excluded, resulting in data from 38 patients being analyzed. In radiological evaluation, the changes in midbuccal alveolar bone height at 5 months were -0.753 ± 0.112 and -1.018 ± 0.111 mm in the SBX group and PBX groups, respectively (F = 2.895; p = 0.098; mean difference [MD] 0.265; 95% confidence interval [CI] = -0.051 to 0.582). Changes in the horizontal ridge width were measured at three levels (-1, -3, and -5 mm) below the most coronal aspect of the crest and showed a decrease in both groups, with no significant differences between the groups. The percent new bone area of the SBX group (39.156 ± 2.505) was significantly different from that of the PBX group (22.749 ± 2.476) (F = 22.171; p < 0.001; 95% MD 16.407; CI = 9.333 to 23.481). The percent residual material area was significantly lower in the SBX group (8.973 ± 2.211) compared to the PBX group (15.633 ± 2.186), with an F-statistic of 4.687 and p-value = 0.037 (MD -6.660; 95% CI = -12.904 to -0.415). The percent connective tissue area was 49.743 ± 4.199 and 56.657 ± 4.151 for the groups (F = 1.401; p = 0.245; MD -6.914; 95% CI = -18.773 to 4.944), respectively.

CONCLUSION

Radiological and histological results showed that use of moldable bone can achieve similar ARP parameters as those achieved by particulate bone.

TRIAL REGISTRATION

Clinical Research Information Service No. KCT0009560. This randomized clinical trial was not registered before participant recruitment and randomization. (Date of registration: 21/06/2024. https://cris.nih.go.kr/cris/search/detailSearch.do?seq=27272&searchpage=L).

摘要

引言

本研究旨在确定使用可塑形骨与颗粒骨进行牙槽嵴保存(ARP)时可能存在的组织学和放射学差异。

方法

拔牙后,39例患者(40颗牙)被随机分为两组(1:1),分别接受使用可塑形骨材料的ARP(SBX组)或颗粒骨材料的ARP(PBX组)。在移植材料上放置可吸收胶原膜,并缝合手术部位。在ARP后立即及5个月时进行锥形束计算机断层扫描。在ARP后5个月从植入部位获取骨芯样本进行组织形态计量分析。

结果

筛选了46例患者,其中39例完成了研究。然而,一名接受分口治疗的患者被排除,最终分析了38例患者的数据。在放射学评估中,SBX组和PBX组在5个月时颊侧牙槽骨高度的变化分别为-0.753±0.112和-1.018±0.111mm(F = 2.895;p = 0.098;平均差值[MD] 0.265;95%置信区间[CI] = -0.051至0.582)。在牙槽嵴最冠方以下三个水平(-1、-3和-5mm)测量水平牙槽嵴宽度变化,两组均显示减小,且组间无显著差异。SBX组的新骨面积百分比(39.156±2.505)与PBX组(22.749±2.476)有显著差异(F = 22.171;p < 0.001;95% MD 16.407;CI = 9.333至23.481)。SBX组的残余材料面积百分比(8.973±2.211)显著低于PBX组(15.633±2.186),F统计量为4.687,p值 = 0.037(MD -6.660;95% CI = -12.904至-0.415)。两组的结缔组织面积百分比分别为49.743±4.199和56.657±4.151(F = 1.401;p = 0.245;MD -6.914;95% CI = -18.773至4.944)。

结论

放射学和组织学结果表明,使用可塑形骨可实现与颗粒骨相似的ARP参数。

试验注册

临床研究信息服务编号KCT0009560。这项随机临床试验在招募参与者和随机分组之前未进行注册。(注册日期:2024年6月21日。https://cris.nih.go.kr/cris/search/detailSearch.do?seq=27272&searchpage=L)

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/64d7/11951245/6972595620e0/CID-27-0-g005.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/64d7/11951245/c2a3be6ea508/CID-27-0-g002.jpg
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