Objectives

The present study aims to compare provisional single crowns on anterior implants made using conventional PMMA and 3D-printed workflows. The study assessed the occurrence of failures, color variation, signs of early deterioration, operating time, and patients' satisfaction with the treatment through a randomized controlled trial.

Methods

This study was conducted as a randomized controlled trial, following the SPIRIT and CONSORT guidelines. Patients were included in the study after meeting the eligibility criteria and were randomly assigned to one of two groups (conventional and 3D-printed). FDI criteria, visible plaque index (VPI), bleeding on probing (BOP), and color variation were considered as the primary outcomes. Operating time and patient satisfaction were also assessed as secondary outcomes. Fisher’s exact test was performed to analyze the association between the primary and secondary outcomes and the study groups. Mann-Whitney test was used to compare the mean VAS satisfaction scores between the conventional PMMA and 3D-printed groups (STATA 14™, with an α = 0.05).

Results

A total of 42 provisional single crowns (n = 21) were made for 33 patients. Only the fracture parameter (FDI) showed a statistically significant difference, with 3D-printed provisionals exhibiting higher rates of catastrophic failures compared to conventional ones (p = 0.05). Although the operating time for the 3D-printed group was shorter (p < 0.001), no statistical difference observed in patients' satisfaction regarding esthetics, phonetics, chewing, or comfort.

Significance

3D-printed and conventional PMMA provisional single crowns showed comparable clinical performance, except for the observed fracture types. Although 3D-printed provisional restorations showed a shorter operating time, overall patients’ satisfaction was not affected.

中文翻译：

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前牙种植体的 3D 打印和传统临时单冠制造：一项随机临床试验

 目标

本研究旨在比较使用传统 PMMA 和 3D 打印工作流程制作的前牙种植体临时单冠。该研究通过随机对照试验评估了失败的发生、颜色变化、早期恶化迹象、手术时间以及患者对治疗的满意度。

 方法

本研究是一项随机对照试验，遵循 SPIRIT 和 CONSORT 指南。患者在符合资格标准后被纳入研究，并被随机分配到两组（传统组和 3D 打印组）中的一组。 FDI 标准、可见斑块指数 (VPI)、探诊出血 (BOP) 和颜色变化被视为主要结果。手术时间和患者满意度也作为次要结果进行评估。进行费舍尔精确检验来分析主要和次要结果与研究组之间的关联。 Mann-Whitney 测试用于比较传统 PMMA 和 3D 打印组之间的平均 VAS 满意度评分（STATA 14™，α = 0.05）。

 结果

总共为 33 名患者制作了 42 个临时单冠（n = 21）。只有断裂参数 (FDI) 显示出统计上的显着差异，与传统临时材料相比，3D 打印临时材料的灾难性故障率更高 (p = 0.05)。尽管 3D 打印组的手术时间较短 (p < 0.001)，但患者在美观、语音、咀嚼或舒适度方面的满意度没有观察到统计学差异。

 意义

除了观察到的骨折类型外，3D 打印和传统 PMMA 临时单冠显示出相似的临床性能。尽管 3D 打印临时修复体的手术时间较短，但患者的总体满意度并未受到影响。