Clinical efficacy of maxillary digital removable partial dentures based on direct intraoral scanning and selective laser melting technology: a double-blind randomized controlled crossover clinical trial

IF 5.5 2区医学 Q1 DENTISTRY, ORAL SURGERY & MEDICINE Journal of dentistry Pub Date : 2025-02-01 Epub Date: 2024-12-26 DOI:10.1016/j.jdent.2024.105542

Chenyuan Zhu , Mengxin Yao , Chengyi Wang , Yaye Ruan , Jiajun Ming , Haixin Qian , Ting Jiao

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Abstract

Objectives

A double-blind randomized controlled crossover clinical trial was conducted to comprehensively evaluate the treatment of maxillary removable partial dentures (RPDs) fabricated using a digital workflow.

Methods

A total of 58 patients were enrolled. The digital procedure involves direct intraoral scanning (IOS), digital design, selective laser melting (SLM) printing Cr-Co metal framework, and the usage of digitally printed resin cast. The outcomes were evaluated from the perspectives of adaptation, clinician evaluation, and patient-centered evaluation.

Results

The adaptation between the two types of dentures showed no statistical difference [RPD-LWT: 274.8(213.50,337.55)μm; RPD-SLM: 302.30(244.40, 368.50) μm; P=0.172). The Kennedy classification and the number of missing teeth would have an impact on the adaptation of RPD SLM. At the 7-day follow-up (T2), there were no significant statistical differences between the two dentures in all indicators in terms of clinician's evaluation. Both groups significantly improved patients' quality of life when compared with baseline measurements. This improvement was mainly reflected by reductions in pain-discomfort levels and psychosocial impacts. The patient's satisfactory with both dentures was statistically similar (P=0.591).

Conclusions

The RPD-SLM and RPD-LWT showed statistically similar results in terms of adaptation, clinician evaluation, and patient-centered evaluation in this in vivo study.

Clinical Significance Statement

This study systematically and comprehensively evaluated the in vivo performance of RPD-SLM compared to RPD-LWT. The findings from this analysis suggest the combination of direct IOS and SLM can be effectively utilized for fabricating maxillary RPDs. This study provides valuable clinical evidence supporting the application of digital technology in RPDs.

Trial registration

China Clinical Trial Registration Center (ChiCTR-ONC-16009899 Registered 17 November 2016, https://www.chictr.org.cn/showproj.html?proj=16865).

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基于直接口内扫描和选择性激光熔化技术的上颌指端可摘局部义齿临床疗效：双盲随机对照交叉临床试验

目的通过双盲随机对照交叉临床试验，综合评价数字化工作流程制作上颌可摘局部义齿的治疗效果。方法共纳入58例患者。数字程序包括直接口内扫描（IOS），数字设计，选择性激光熔化（SLM）打印Cr-Co金属框架，以及数字打印树脂铸件的使用。从适应、临床医师评价和以患者为中心评价三个方面对结果进行评价。结果两种义齿的适应度差异无统计学意义[RPD-LWT: 274.8(213.50,337.55)μm；RPD-SLM: 302.30(244.40, 368.50) μm；P = 0.172)。Kennedy分类和缺牙数量对RPD SLM的适应有影响。随访7 d （T2）时，两种义齿的临床医师评价各项指标比较，差异均无统计学意义。与基线测量值相比，两组患者的生活质量均有显著改善。这种改善主要反映在疼痛不适程度和心理社会影响的减少上。患者对两种义齿的满意度差异有统计学意义（P=0.591）。结论在本体内研究中，RPD-SLM和RPD-LWT在适应性、临床评价和以患者为中心的评价方面具有统计学上相似的结果。临床意义声明本研究系统、全面地评价了RPD-SLM与RPD-LWT的体内性能。本研究结果表明，直接内固定与内固定相结合可以有效地用于上颌rpd的制作。本研究为数字技术在RPDs中的应用提供了有价值的临床证据。中国临床试验注册中心（ChiCTR-ONC-16009899注册于2016年11月17日，https://www.chictr.org.cn/showproj.html?proj=16865）。

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来源期刊

Journal of dentistry 医学-牙科与口腔外科

CiteScore

7.30

自引率

11.40%

发文量

349

审稿时长

35 days

期刊介绍： The Journal of Dentistry has an open access mirror journal The Journal of Dentistry: X, sharing the same aims and scope, editorial team, submission system and rigorous peer review. The Journal of Dentistry is the leading international dental journal within the field of Restorative Dentistry. Placing an emphasis on publishing novel and high-quality research papers, the Journal aims to influence the practice of dentistry at clinician, research, industry and policy-maker level on an international basis. Topics covered include the management of dental disease, periodontology, endodontology, operative dentistry, fixed and removable prosthodontics, dental biomaterials science, long-term clinical trials including epidemiology and oral health, technology transfer of new scientific instrumentation or procedures, as well as clinically relevant oral biology and translational research. The Journal of Dentistry will publish original scientific research papers including short communications. It is also interested in publishing review articles and leaders in themed areas which will be linked to new scientific research. Conference proceedings are also welcome and expressions of interest should be communicated to the Editor.