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不同制作流程对两颗种植体间杆卡式固位夹板修复后被动适合度的影响:一项平行盲法随机临床试验。

Effect of different fabrication workflows on the passive fit of screw-retained bar splinting two interforaminal implants: a parallel blinded randomised clinical trial.

机构信息

Oral and Maxillofacial Prosthodontics Department, Faculty of Dentistry, Ain Shams University, Organization of African Unity Street, Cairo, Egypt.

出版信息

BMC Oral Health. 2024 Apr 2;24(1):410. doi: 10.1186/s12903-024-04157-1.

Abstract

BACKGROUND

To clinically compare the effect of the conventional and the digital workflows on the passive fit of a screw retained bar splinting two inter-foraminal implants.

METHODS

The current study was designed to be a parallel triple blinded randomised clinical trial. Thirty six completely edentulous patients were selected and simply randomized into two groups; conventional group (CG) and digital group (DG). The participants, investigator and outcome assessor were blinded. In the group (CG), the bar was constructed following a conventional workflow in which an open top splinted impression and a lost wax casting technology were used. However, in group (DG), a digital workflow including a digital impression and a digital bar milling technology was adopted. Passive fit of each bar was then evaluated clinically by applying the screw resistance test using the "flag" technique in the passive and non passive situations. The screw resistance test parameter was also calculated. Unpaired t-test was used for intergroup comparison. P-value < 0.05 was the statistical significance level. The study protocol was reviewed by the Research Ethics Committee in the author's university (Rec IM051811). Registration of the clinical trial was made on clinical trials.gov ID NCT05770011. An informed consent was obtained from all participants.

RESULTS

Non statistically significant difference was denoted between both groups in all situations. In the passive situation, the mean ± standard deviation values were 1789.8° ± 20.7 and1786.1° ± 30.7 for the groups (CG) and (DG) respectively. In the non passive situation, they were 1572.8° ± 54.2 and 1609.2° ± 96.9. Regarding the screw resistance test parameter, they were 217° ± 55.3 and 176° ± 98.8.

CONCLUSION

Conventional and digital fabrication workflows had clinically comparable effect on the passive fit of screw retained bar attachments supported by two dental implants.

摘要

背景

本临床研究旨在比较常规和数字化工作流程对双种植体间支抗螺丝固位杆被动适合度的影响。

方法

本研究设计为平行三盲随机临床试验。选择 36 名完全无牙的患者,并简单随机分为两组:常规组(CG)和数字组(DG)。参与者、研究者和结果评估者均设盲。在 CG 组中,采用常规工作流程制作杆,该流程使用开放式顶部夹板印模和失蜡铸造技术。然而,在 DG 组中,采用了包括数字化印模和数字化杆铣削技术的数字化工作流程。然后通过应用“标志”技术的螺丝阻力测试临床评估每个杆的被动适合度,分别在被动和非被动状态下进行。还计算了螺丝阻力测试参数。组间比较采用了独立样本 t 检验。P 值<0.05 为统计学显著性水平。该研究方案已由作者所在大学的研究伦理委员会(Rec IM051811)审查。临床试验已在 clinicaltrials.gov 注册,ID NCT05770011。所有参与者均获得知情同意。

结果

在所有情况下,两组之间均未发现统计学显著差异。在被动状态下,CG 组和 DG 组的平均(±标准差)值分别为 1789.8°±20.7 和 1786.1°±30.7。在非被动状态下,它们分别为 1572.8°±54.2 和 1609.2°±96.9。关于螺丝阻力测试参数,它们分别为 217°±55.3 和 176°±98.8。

结论

常规和数字化制作工作流程对双种植体间支抗螺丝固位杆附着体的被动适合度具有临床可比性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8f2a/10985940/390a56547946/12903_2024_4157_Fig1_HTML.jpg

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