玻璃混合体与复合材料治疗非龋性颈前病变：3 年随机对照试验后的生存率、修复质量和成本。

Glass hybrid versus composite for non-carious cervical lesions: Survival, restoration quality and costs in randomized controlled trial after 3 years.

机构信息

Department of Oral Diagnostics, Digital Health, Health Services Research, Charité - Universitätsmedizin Berlin, Germany.

出版信息

J Dent. 2021 Jul;110:103689. doi: 10.1016/j.jdent.2021.103689. Epub 2021 May 9.

DOI:10.1016/j.jdent.2021.103689

PMID:33979577

Abstract

OBJECTIVE

This study compared survival, restoration quality and costs of glass hybrid (GH; EQUIA Forte Fil/EQUIA Forte Coat) and resin composite restorations (RC; OptiBond FL/Filtek Supreme XTE) of sclerotic non-carious cervical lesions.

METHODS

This is a cluster-randomized trial (ClinicalTrials.gov: NCT02631161). 88 patients (50-70 years) with 175 sNCCLs were randomized to receive GH or RC. Restorations were placed without mechanical cavity preparation and followed for a mean 36 (min/max: 31/55) months (variable follow-up due to COVID-19 lockdown). Restoration quality was re-evaluated at 1-, 18- and 36-months using FDI-criteria. Survival was assessed using multi-level Cox-regression analysis. Costs were estimated from a payer's perspective in Germany. Initial costs were determined based on micro-costing using time recordings and hourly costs, and follow-up costs based on statutory insurance fee-item-catalogues.

RESULTS

88 patients (175 restorations) were treated; 43 received GH (83 restorations), 45 RC (92 restorations). 17  GH and 19 RC showed total retention loss, 5  GH were partially lost (p = 0.396/Cox). FDI ratings were not sufficiently different for any domain except surface luster, where RC showed higher score (p < 0.001). Costs were initially lower for GH (32.57; SD 16.36 €) than RC (44.25; SD 21.40 €), while re-treatment costs were similar (GH: 9.15; SD 15.70 €; RC: 7.35; SD 14.51 €), resulting in significantly lower costs for GH (GH: 41.72; SD 25.08 €) than RC (51.60; 26.17 €) (p < 0.001/GLM).

CONCLUSIONS

While survival was not significantly different, GH was significantly less costly both initially and long-term than RC for restoring non-carious cervical lesions.

CLINICAL SIGNIFICANCE

Within this trial, survival was not significantly different between GH and RC to restore sclerotic NCCLs. As GH was significantly less costly both initially and long-term than RC, using RC was only cost-effective for payers willing to invest high additional expenses per minimal survival gains.

摘要

目的

本研究比较了玻璃混合（GH；EQUIA Forte Fil/EQUIA Forte Coat）和树脂复合材料修复（RC；OptiBond FL/Filtek Supreme XTE）硬化性非龋性颈病变的生存率、修复质量和成本。

方法

这是一项集群随机试验（ClinicalTrials.gov：NCT02631161）。88 名（50-70 岁）患有 175 例 sNCCL 的患者被随机分为 GH 或 RC 组。在没有机械腔制备的情况下放置修复体，并平均随访 36 个月（min/max：31/55）（由于 COVID-19 封锁，可变随访）。使用 FDI 标准在 1、18 和 36 个月时重新评估修复质量。使用多级 Cox 回归分析评估生存率。成本从德国付款人的角度进行估算。初始成本基于使用时间记录和每小时成本的微观成本核算确定，后续成本基于法定保险费项目目录确定。

结果

治疗了 88 名患者（175 例修复体）；43 例接受 GH（83 例修复体），45 例 RC（92 例修复体）。17 例 GH 和 19 例 RC 出现完全保留损失，5 例 GH 部分损失（p=0.396/Cox）。除表面光泽外，任何领域的 FDI 评分均无明显差异，RC 评分较高（p<0.001）。GH 的初始成本（32.57；SD 16.36 欧元）低于 RC（44.25；SD 21.40 欧元），而再治疗成本相似（GH：9.15；SD 15.70 欧元；RC：7.35；SD 14.51 欧元），导致 GH 的成本明显低于 RC（GH：41.72；SD 25.08 欧元）低于 RC（51.60；SD 26.17 欧元）（p<0.001/GLM）。