新型泡沫后牙科凝胶对牙龈炎症的疗效：一项随机对照临床试验。

Efficacy of a novel post-foaming dental gel on gingival inflammation: A randomized controlled clinical trial.

机构信息

GLO Science, Inc., New York, New York, USA.

Center for Clinical and Translational Research, The Forsyth Institute, Cambridge, Massachusetts, USA.

出版信息

J Periodontol. 2020 Dec;91(12):1569-1583. doi: 10.1002/JPER.19-0594. Epub 2020 Jul 16.

DOI:10.1002/JPER.19-0594

PMID:32372407

Abstract

BACKGROUND

A pilot randomized controlled clinical trial was performed to evaluate the efficacy of a post-foaming dental gel containing cetylpridinium chloride (CPC), hydrogen peroxide (H O ), sodium bicarbonate, and antioxidants on periodontal/oral health.

METHODS

Individuals with gingivitis or mild-moderate periodontitis (n=36) were included and randomly assigned to Group 1 and 2 with foaming gel loaded on a mouthpiece with a light source and controlled warming heat built-in unit or on a toothbrush, respectively, in addition to regular twice-daily brushing. Group 3 served as control with twice daily brushing and further assigned split-mouth to Group 3a-un-flossed and Group 3b-flossed. Gingival index (GI) and bleeding on probing (BOP) were evaluated in addition to plaque index (PI), pocket depth, and clinical attachment level at days 14, 28, 42 (treatment), and 60 (maintenance). Subgingival plaque microbial profiles and gingival crevicular fluid (GCF) cytokine levels were determined by DNA-DNA hybridization and multiplexing assays, respectively. Exploratory analyses included esthetic outcomes: changes in tooth color and levels of volatile sulfur compounds in breath. Statistical analyses were conducted using ANOVA with a post hoc analysis of Fisher's LSD.

RESULTS

Use of post-foaming gel in both test groups resulted in significant changes in GI and BOP at Day 42 compared to control and un-flossed control (P<0.05). Device-enhanced foaming gel significantly reduced the PI in Group 1 at Day 42 compared to control and un-flossed control (P=0.02; P=0.007, respectively). GCF IL-6 and TNF-α levels were significantly reduced in Group 2 compared to control (P =0.01, P =0.02). Post-foaming gel resulted in greater reductions in periodontopathogens, whereas health-associated species remained stable. Despite cessation of adjunct treatments, Group 1 and 2 continued having reduced levels of GI, BOP, and PI at Day 60 (P<0.05).

CONCLUSIONS

The novel post-foaming dental gel improves oral health by reducing gingival inflammation at the local site in addition to better esthetic outcomes.

摘要

背景

一项试点随机对照临床试验评估了一种含有十六烷基吡啶氯（CPC）、过氧化氢（H2O2）、碳酸氢钠和抗氧化剂的泡沫后牙科凝胶在牙周/口腔健康方面的疗效。

方法

将患有牙龈炎或轻度-中度牙周炎的个体（n=36）纳入研究，并随机分配至使用内置光源和控温加热的泡沫载具的第 1 组和第 2 组，或使用牙刷的第 1 组和第 2 组，此外还需进行每日两次的常规刷牙。第 3 组为每日两次刷牙的对照组，并进一步分为未使用牙线的第 3a 组和使用牙线的第 3b 组。在第 14、28、42 天（治疗期）和 60 天（维持期），评估牙龈指数（GI）和探诊出血（BOP），以及菌斑指数（PI）、牙周袋深度和临床附着水平。通过 DNA-DNA 杂交和多重分析分别确定龈下菌斑微生物谱和龈沟液（GCF）细胞因子水平。探索性分析包括美学结果：牙齿颜色变化和口气中挥发性硫化合物水平。使用方差分析（ANOVA）进行统计分析，并进行 Fisher's LSD 事后分析。

结果

与对照组和未使用牙线对照组相比，两组试验组在第 42 天使用泡沫后凝胶后，GI 和 BOP 均有显著变化（P<0.05）。设备增强型泡沫凝胶在第 42 天使第 1 组的 PI 与对照组和未使用牙线对照组相比显著降低（P=0.02；P=0.007，分别）。与对照组相比，第 2 组的 GCF IL-6 和 TNF-α水平显著降低（P=0.01，P=0.02）。泡沫后凝胶导致牙周病病原体减少更多，而与健康相关的物种保持稳定。尽管停止辅助治疗，第 1 组和第 2 组在第 60 天仍保持较低的 GI、BOP 和 PI 水平（P<0.05）。