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计算机辅助设计与制造(CAD/CAM)钛合金固定舌侧保持器与传统不锈钢固定保持器的有效性比较(随机对照临床试验)

Effectiveness of CAD/CAM titanium fixed lingual retainer versus conventional stainless steel fixed retainer (randomized controlled clinical trial).

作者信息

Elhosseiny Nada E A, Marzouk Wessam M, Tageldin Mostafa A

机构信息

Department of Orthodontics, Faculty of Dentistry, Alexandria University, Champolion St., Alexandria, Azarita, 21527, Alexandria, Egypt.

Faculty of Dentistry, Alexandria University, Alexandria, Egypt.

出版信息

Clin Oral Investig. 2025 Jun 18;29(7):343. doi: 10.1007/s00784-025-06418-x.

Abstract

BACKGROUND

Retention after orthodontic treatment is crucial to maintain aligned teeth and prevent relapse. Traditional fixed retainers, made from multistranded stainless steel wires, are effective but have drawbacks such as operator variability, long chair-time, and risk of biofilm accumulation. Recent advancements in computer-aided design/computer-aided manufacturing (CAD/CAM) technology proposed custom-designed fixed retainers as a modern solution.

THE AIM OF THIS TRIAL

Primary aim was to evaluate the alignment stability of CAD/CAM grade 5 titanium (Ti5) versus stainless steel lingual fixed retainers. Secondary aim was to assess periodontal health over 6-months.

METHODS

A single-center, two-arm, parallel randomized controlled clinical trial with a 1:1 allocation ratio was carried out to address the aims of the study. Participants were randomly allocated into two equal groups: Group I received Ti5 CAD/CAM lingual retainers; Group II received conventional 8-strand braided stainless-steel fixed retainers. Both retainers were bonded directly on the six mandibular anterior teeth. Measurements were performed at 3 time points: immediately after retainer placement (T0), after 3 months (T3) and after 6 months (T6). Intercanine Width, Little’s Irregularity Index and tooth movements in buccolingual, mesiodistal, occluso-gingival and rotational directions were recorded for each tooth by superimposition of digital models. In addition, periodontal parameters (Plaque index, Gingival index, Probing depth and Bleeding on probing) were assessed.

RESULTS

Initially, 54 patients were screened for eligibility. A total of 36 patients were randomly assigned, completed follow-up, and were included in the analysis. The used test for comparison between variance were Chi-square, Welch’s t test and Greenhouse-Geisser test. Inter-canine width showed no statistically significant differences between the two groups at T0, T3, or T6 ( = 0.769,  = 0.440 and  = 0.827 respectively). Little’s Irregularity Index revealed no statistically significant difference between the two retainers at T0 ( = 0.123), T3( = 0.562) and T6( = 0.611). No significant changes in tooth positions were observed in the two groups. The mean change of Gingival index showed a significant decrease in CAD/CAM group compared to conventional at (T3 and T6  = 0.001). The periodontal parameters were significantly better in the CAD/CAM retainers after 6-months.

CONCLUSIONS

Ti5 CAD/CAM and conventional retainers are effective in maintaining intercanine width. Ti5 CAD/CAM retainers are capable of maintaining tooth position in three dimensional directions. Ti5 CAD/CAM retainers showed less deterioration of the periodontium in short-term observation.

摘要

背景

正畸治疗后的保持对于维持牙齿排列整齐和防止复发至关重要。传统的固定保持器由多股不锈钢丝制成,虽然有效,但存在诸如操作者差异、椅旁时间长以及生物膜积聚风险等缺点。计算机辅助设计/计算机辅助制造(CAD/CAM)技术的最新进展提出定制设计的固定保持器作为一种现代解决方案。

本试验的目的

主要目的是评估CAD/CAM 5级钛(Ti5)与不锈钢舌侧固定保持器的排列稳定性。次要目的是评估6个月内的牙周健康状况。

方法

为实现研究目的,开展了一项单中心、双臂、平行随机对照临床试验,分配比例为1:1。参与者被随机分为两组:第一组接受Ti5 CAD/CAM舌侧保持器;第二组接受传统的8股编织不锈钢固定保持器。两种保持器均直接粘结在下颌六颗前牙上。在3个时间点进行测量:保持器放置后立即(T0)、3个月后(T3)和6个月后(T6)。通过数字模型叠加记录每颗牙齿的牙间宽度、利特尔不规则指数以及颊舌向、近远中向、咬合龈向和旋转方向的牙齿移动情况。此外,评估牙周参数(菌斑指数、牙龈指数、探诊深度和探诊出血)。

结果

最初,筛选了54名患者的 eligibility。共有36名患者被随机分配、完成随访并纳入分析。用于方差比较的检验为卡方检验、韦尔奇t检验和格林豪斯-盖泽检验。两组在T0、T3或T6时的牙间宽度均无统计学显著差异(分别为 = 0.769、 = 0.440和 = 0.827)。利特尔不规则指数在T0( = 0.123)、T3( = 0.562)和T6( = 0.611)时,两种保持器之间无统计学显著差异。两组牙齿位置均未观察到显著变化。与传统组相比,CAD/CAM组牙龈指数的平均变化在(T3和T6时 = 0.001)显示出显著下降。6个月后,CAD/CAM保持器的牙周参数明显更好。

结论

Ti5 CAD/CAM和传统保持器在维持牙间宽度方面均有效。Ti5 CAD/CAM保持器能够在三维方向上维持牙齿位置。在短期观察中,Ti5 CAD/CAM保持器显示出牙周组织恶化程度较低。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8856/12174219/ff65e43ede8a/784_2025_6418_Fig1_HTML.jpg

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