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用于牙槽窝保存技术的3D可打印生物聚合物:软组织反应:一项初步随机临床研究

3D-Printable Biopolymers for Socket Preservation Technique: Soft Tissues Response: A Pilot Randomised Clinical Study.

作者信息

De Angelis Nicola, Pesce Paolo, Poedjiastoeti Wiwiek, Suwandi Trijani, Tjandrawinata Rosalina, Bagnasco Francesco, Menini Maria

机构信息

Unit of Prosthodontics and Implant Prosthodontics, Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, 16126 Genova, Italy.

Department of Periodontology, Faculty of Dentistry, Universitas Trisakti, Jakarta 11440, Indonesia.

出版信息

Dent J (Basel). 2024 Oct 7;12(10):321. doi: 10.3390/dj12100321.

Abstract

BACKGROUND

The aim of the present parallel clinical study is to evaluate the efficacy of 3D-printed biopolymers compounded with osteoconductive material (beta-tricalcium phosphate and hydroxyapatite) for soft tissue closure after tooth extraction.

MATERIALS AND METHODS

this study followed the CONSORT reporting guidelines; 39 patients were treated with socket preservation using 3D-printed biopolymers and randomly divided into 3 groups (Test 1, Test 2, and Control). All cases were treated without flap elevation, careful cleaning and debridement of the sites, and then randomly sealed as follows: In T1, with a 3D-printed disk of poli-D-lactic acid with 10% of hydroxyapatite; in T2, using a 3D-printed disk of poli-ε caprolactone with 20% of β-tricalcium phosphate; and in T3, the socket was left open to heal. At baseline (extraction time) and 6 weeks after extraction, the rate of exposure was evaluated and stratified according to the site (anterior, posterior).

RESULTS

No dropouts were observed during the 6 weeks follow-up. All sites underwent uneventful healing with no complications. For posterior teeth, Test 1 and Test 2 showed full healing of the soft tissues with a reduction of the exposed area from 46.5 ± 8.25 mm to 0.6 ± 0.84 mm and from 47.1 ± 8.67 mm to 0.6 ± 0.7 mm, respectively. The Control group exhibited a reduction from 45.6 ± 7.25 mm to 1.2 ± 0.9 mm. Both Tests 1 and 2, when compared to the Control group, showed statistically significant better healing ( < 0.05). Anterior teeth showed a complete closure of the socket 4 weeks after the extraction with no noticeable differences between Test and Control.

CONCLUSIONS

Both materials used in this study showed evidence to achieve the purpose. Ethical Guidelines: written informed consent was obtained from the participants of the study, as requested by the Ethics Committee for Health Research Faculty of Dentistry, Universitas Trisakti, with the following number: 641/S3/KEPK/FKG/5/2023.

摘要

背景

本平行临床研究的目的是评估与骨传导材料(β-磷酸三钙和羟基磷灰石)复合的3D打印生物聚合物在拔牙后软组织封闭中的疗效。

材料与方法

本研究遵循CONSORT报告指南;39例患者采用3D打印生物聚合物进行牙槽窝保存,并随机分为3组(试验1组、试验2组和对照组)。所有病例均在不翻瓣的情况下进行治疗,仔细清洁和清创拔牙部位,然后随机进行如下封闭:在试验1组,使用含10%羟基磷灰石的聚-D-乳酸3D打印盘;在试验2组,使用含20%β-磷酸三钙的聚-ε-己内酯3D打印盘;在试验3组,牙槽窝敞开愈合。在基线(拔牙时)和拔牙后6周,评估暴露率并根据部位(前牙、后牙)进行分层。

结果

在6周的随访期间未观察到失访病例。所有部位均顺利愈合,无并发症。对于后牙,试验1组和试验2组软组织完全愈合,暴露面积分别从46.5±8.25mm减少到0.6±0.84mm和从47.1±8.67mm减少到0.6±0.7mm。对照组暴露面积从45.6±7.25mm减少到1.2±0.9mm。试验1组和试验2组与对照组相比,均显示出统计学上显著更好的愈合效果(P<0.05)。前牙在拔牙后4周牙槽窝完全封闭,试验组和对照组之间无明显差异。

结论

本研究中使用的两种材料均显示出达到目的的证据。伦理准则:按照特里萨克蒂大学牙科学院健康研究伦理委员会的要求,获得了研究参与者的书面知情同意,编号如下:641/S3/KEPK/FKG/5/2023。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/990d/11506638/33a9ca60d635/dentistry-12-00321-g001.jpg

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