长期评价实验性草酸钾浓度对牙本质敏感缓解的效果：一项三盲随机临床试验。

A long-term evaluation of experimental potassium oxalate concentrations on dentin hypersensitivity reduction: A triple-blind randomized clinical trial.

机构信息

Department of Operative Dentistry and Dental Materials, School of Dentistry, Federal University of Uberlândia, Uberlândia, Minas Gerais, 38400-902, Brazil.

出版信息

J Dent. 2019 Oct;89:103180. doi: 10.1016/j.jdent.2019.103180. Epub 2019 Aug 12.

DOI:10.1016/j.jdent.2019.103180

PMID:31415787

Abstract

OBJECTIVE

The aim of this split-mouth, triple-blind, randomized clinical trial was to evaluate the long-term clinical efficacy of experimental potassium oxalate concentration (10%) in relieving dentin hypersensitivity (DH), after a four-session application protocol.

METHODS

Potassium oxalate gels with different concentrations (5 and 10%) were randomly assigned to half of the 31 patients from the sample in a split-mouth design. The desensitizers were applied following a four-session protocol, one session every 48 h. The primary outcome was the assessment of pain level with the visual analog scale (VAS, 0-10), at baseline, immediately after each desensitizing session, and also after the seventh day and along 1-,3-, 6-, 9- and 12-months follow-ups. Statistical analyses were performed using Friedman repeated measures and Wilcoxon signed rank tests (α = 0.05).

RESULTS

For both groups, the minimum of three sessions were required for the achievement of lower DH levels. Regardless of the concentration, the desensitizing effect was maintained all the way to the end of the 6-month follow-up. The 10%-potassium oxalate group was more effective for both 9 and 12-months follow-up periods (p < 0.001). No complications and adverse effects were observed.

CONCLUSIONS

When a four-session protocol is applied, both concentrations of potassium oxalate (5 and 10%) proved to be effective on DH reduction for up to six months. However, the higher concentration promoted better long-term results.

CLINICAL SIGNIFICANCE

The DH is an increasing condition in clinical practice, which affects the patient's life quality. This study provides primary clinical evidence, suggesting that multiple application sessions and higher concentrations of potassium oxalate may result in maintenance of the desensitizing effect for more extended periods. Trial registered under number: ClinicalTrials.gov NCT03083496.

摘要

目的

本双盲、随机对照临床试验的目的是评估四疗程应用方案后，实验性草酸钾浓度（10%）缓解牙本质敏感症（DH）的长期临床疗效。

方法

采用裂口设计，将来自样本的 31 名患者中的一半随机分配到不同浓度（5%和 10%）的草酸钾凝胶组。脱敏剂每 48 小时应用一次，共应用四疗程。主要结局指标为视觉模拟评分（VAS，0-10）评估疼痛水平，分别在基线、每次脱敏治疗后即刻以及第 7 天、1、3、6、9 和 12 个月随访时进行评估。采用 Friedman 重复测量和 Wilcoxon 符号秩检验（α=0.05）进行统计分析。