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数字化和传统印模技术在儿童患者中偏好、时间和舒适度方面的比较:一项交叉随机对照试验。

Comparison between digital and conventional impression techniques in children on preference, time and comfort: A crossover randomized controlled trial.

机构信息

Graduate Orthodontic Program, Department of Experimental and Clinical Medicine, The University of Florence, Florence, Italy.

Department of Experimental and Clinical Medicine, The University of Florence, Florence, Italy.

出版信息

Orthod Craniofac Res. 2023 Nov;26(4):585-590. doi: 10.1111/ocr.12648. Epub 2023 Mar 20.

Abstract

OBJECTIVE

To compare the conventional alginate impression and the digital impression taken with an intraoral scanner of both dental arches in children, using a randomized crossover design.

TRIAL DESIGN

This is a monocentric, controlled, superiority, randomized, crossover, open study.

METHODS

Twenty-four orthodontic patients between 6 and 11 years of age underwent intraoral scanning (TRIOS 3; 3Shape) and alginate impression of both dental arches with an interval of 1 week between the two procedures. Participants were recruited from September 2021 to March 2022 and the study was completed in April 2022. Impression time for the two procedures was compared. Patients were asked which one of the two impression procedures they preferred. A questionnaire including Visual Analogue Scale (VAS) for comfort, pain, gag reflex and difficulty in breathing, was administered to the patients.

RESULTS

Eighteen out of 24 patients preferred digital impression (75%, 95% confidence interval [CI]: 55% to 88%; P = .014). Scanning time was significantly shorter than alginate impression time (difference -118 seconds; 95% CI: -138 to -99; P < .001). Comfort was significantly higher for digital impression (difference 1.7; 95% CI: 0.5 to 2.8; P = .007). There was no difference in pain (difference -0.2; 95% CI: -1.5 to 1.0; P = .686) while gag reflex and breathing difficulties were smaller for digital impression (gag reflex difference -2.5; 95% CI: -4.0 to -0.9; P = .004 and breathing difficulties difference -1.5; 95% CI: -2.5 to -0.5; P = -.004).

CONCLUSIONS

Digital impression is preferred by children aged 6-11 years and it is significantly faster in acquisition time than conventional alginate impression.

REGISTRATION

The study was registered on ClinicalTrials.gov with registration number NCT04220957 on January 7th, 2020 (https://clinicaltrials.gov/ct2/show/NCT04220957).

摘要

目的

采用随机交叉设计,比较儿童上下颌全牙弓的常规藻酸盐印模和口内扫描仪的数字印模。

试验设计

这是一项单中心、对照、优势、随机、交叉、开放性研究。

方法

2021 年 9 月至 2022 年 3 月期间,24 名 6 至 11 岁的正畸患者接受了上下颌全牙弓的口内扫描(TRIOS 3;3Shape)和藻酸盐印模,两次操作之间间隔 1 周。从 2021 年 9 月至 2022 年 3 月期间招募参与者,并于 2022 年 4 月完成研究。比较两种方法的印模时间。患者被要求选择两种印模方法中的哪一种。向患者发放包括舒适度、疼痛、吞咽反射和呼吸困难的视觉模拟量表(VAS)在内的问卷。

结果

24 名患者中有 18 名(75%,95%置信区间[CI]:55%至 88%;P=0.014)更喜欢数字印模。扫描时间明显短于藻酸盐印模时间(差值-118 秒;95%CI:-138 至-99;P<0.001)。数字印模的舒适度明显更高(差值 1.7;95%CI:0.5 至 2.8;P=0.007)。疼痛无差异(差值-0.2;95%CI:-1.5 至 1.0;P=0.686),而吞咽反射和呼吸困难较小(吞咽反射差值-2.5;95%CI:-4.0 至-0.9;P=0.004 和呼吸困难差值-1.5;95%CI:-2.5 至-0.5;P=-.004)。

结论

6-11 岁儿童更喜欢数字印模,并且在采集时间上明显快于传统的藻酸盐印模。

注册

该研究于 2020 年 1 月 7 日在 ClinicalTrials.gov 上注册,注册号为 NCT04220957(https://clinicaltrials.gov/ct2/show/NCT04220957)。

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