评估Katana™清洁剂对根管治疗后牙齿的大块充填修复体临床性能的影响：一项随机临床研究的研究方案。

Assessing the influence of Katana™ Cleaner on the clinical performance of bulk-fill restorations in endodontically treated teeth: study protocol for a randomized clinical study.

作者信息

Azevedo Jacqueline Vitória do Nascimento, Carvalho Ceci Nunes, Leite Hadda Lyzandra Austriaco, Lima Suellen Nogueira Linares, Mendes Wallace Vieira, Pinheiro Neto Sebastião Marinho, Cardenas Andrés Felipe Millian, Siqueira Fabiana Suellen Figueredo, de Almeida Rossana Aboud Matos, Maia Filho Etevaldo Matos

机构信息

Post-Graduation Program in Dentistry, Ceuma University, São Luís, Brazil.

Post-Graduation Program in Dentistry, Federal University of Maranhão, São Luís, Brazil.

出版信息

Trials. 2025 May 7;26(1):148. doi: 10.1186/s13063-025-08790-1.

DOI:10.1186/s13063-025-08790-1

PMID:40336030

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12060364/

Abstract

BACKGROUND

Complete cleaning of the pulp chamber interior is a mandatory step before the restorative process. Ethanol is the most commonly used substance for cleaning the dentin surface; however, studies report that ethanol is ineffective at completely removing residues. Although Katana™ is recommended for prosthetic purposes, in vitro studies have shown it delivers results equal to or better than ethanol. The study aims to evaluate the influence of Katana™ Cleaner on cleaning the pulp chamber of teeth treated endodontically with an epoxy or bioceramic sealer and on the clinical performance of bulk-fill resin restorations over an 18-month follow-up period, using two clinical performance criteria: World Dental Federation (FDI) and United States Public Health Service (USPHS).

METHODS

The study will be a blinded randomized clinical trial conducted according to the Consolidated Standards of Reporting Trials (CONSORT) statement. Selected patients (n = 224) will undergo pulp chamber cleaning following endodontic obturation with epoxy and bioceramic sealers, divided into four treatment groups (Katana and AH Plus, Katana and Bioceramic, Ethanol and AH Plus, Ethanol and Bioceramic), followed by bulk-fill resin restorations. The clinical performance of the restorations will be evaluated at the following intervals: 1 week, 3, 6, 9, 12, 15, and 18 months, using two evaluation criteria: FDI and USPHS. Results will be analyzed using survival analysis with the Kaplan-Meier estimator to assess failure occurrence over time for the two treatments. A Cox regression analysis will be conducted to evaluate the risk of failure. A 5% significance level will be adopted for all tests.

DISCUSSION

The proposed study will be the first to examine the clinical effects of a new cleaning protocol on the removal of endodontic sealer residues. We will also explore potential improvements that Katana may provide in the bond strength of a self-etch adhesive to dentin in teeth restored with composite resin. If promising results are observed in clinical trials, this would suggest that individuals could benefit from the intervention using the proposed protocol, highlighting the potential for improved outcomes in the restorations of endodontically treated teeth. Additionally, it could pave the way for future studies in this field.

TRIAL REGISTRATION

Registered in the Brazilian Registry of Clinical Trials (REBEC: RBR-86ycwq7) on February 29, 2024.

摘要

背景

在进行修复治疗之前，彻底清洁髓腔内部是必不可少的步骤。乙醇是清洁牙本质表面最常用的物质；然而，研究报告称乙醇无法完全去除残留物。尽管Katana™推荐用于修复目的，但体外研究表明其效果等同于或优于乙醇。本研究旨在评估Katana™清洁剂对使用环氧树脂或生物陶瓷封闭剂进行过根管治疗的牙齿髓腔清洁的影响，以及在18个月的随访期内，使用世界牙科联盟（FDI）和美国公共卫生服务部（USPHS）这两项临床性能标准，对大块充填树脂修复体临床性能的影响。

方法

本研究将是一项根据《报告试验的统一标准》（CONSORT）声明进行的双盲随机临床试验。选定的患者（n = 224）在使用环氧树脂和生物陶瓷封闭剂进行根管充填后，将进行髓腔清洁，分为四个治疗组（Katana和AH Plus、Katana和生物陶瓷、乙醇和AH Plus、乙醇和生物陶瓷），随后进行大块充填树脂修复。将在以下时间间隔评估修复体的临床性能：1周、3、6、9、12、15和18个月，使用两项评估标准：FDI和USPHS。将使用Kaplan-Meier估计器进行生存分析，以评估两种治疗方法随时间的失败发生率。将进行Cox回归分析以评估失败风险。所有测试将采用5%的显著性水平。

讨论

拟议的研究将是首个检验新清洁方案对去除根管封闭剂残留临床效果的研究。我们还将探索Katana在复合树脂修复牙齿中自酸蚀粘结剂与牙本质粘结强度方面可能提供的潜在改进。如果在临床试验中观察到有前景的结果，这将表明个体可能从使用拟议方案的干预中受益，突出在根管治疗牙齿修复中改善结果的潜力。此外，它可为该领域的未来研究铺平道路。