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一项为期 6 个月的随机对照试验,旨在测量含有硝酸盐和磷酸盐稳定的氟化亚锡(SNaP)牙膏对牙菌斑和牙龈炎的疗效。

A 6-Month Randomized Controlled Trial to Measure the Efficacy of a Stannous Fluoride Toothpaste Stabilized With Nitrate and Phosphates (SNaP) on Dental Plaque and Gingivitis.

机构信息

Clinical Professor, Loma Linda University, Loma Linda, California.

Distinguished Professor, Loma Linda University, Loma Linda, California.

出版信息

Compend Contin Educ Dent. 2024 Nov-Dec;45(Suppl 3):21-29.

PMID:39566484
Abstract

BACKGROUND

The objective of this randomized controlled trial was the comparison of a stannous fluoride (SnF2) dentifrice stabilized with nitrate and phosphates (test) to a regular fluoride dentifrice (negative control) for the control of plaque and gingivitis over 6 months.

METHODS

A total of 80 adult participants were enrolled in this study that was conducted in Loma Linda, California. After randomization and blinding of study personnel and patients, enrolled participants were provided instructions for the use of their assigned dentifrice. At three visits (0, 3, and 6 months), various gingival and plaque indices were collected to determine the clinical efficacy of the SnF2 stabilized dentifrice. These results were compared with the results of the negative control dentifrice.

RESULTS

A total of 77 participants completed the study. The test dentifrice demonstrated statistically significant reductions versus baseline in all plaque and gingivitis indices after 3 and 6 months of product use. The negative control dentifrice demonstrated significant reductions versus baseline in all plaque indices, but not gingivitis indices, after 3 months of product use and in all plaque and gingivitis indices after 6 months of product use, with the exception of the interproximal gingivitis index, which did not reach statistical significance. The test SnF2 dentifrice showed statistically significant reductions in all plaque and gingivitis indices compared to baseline and with the negative control dentifrice (P less than .001) after 3 months and 6 months of product use.

CONCLUSIONS

The results of this clinical trial showed statistically significantly improved clinical outcomes for reduction of gingival inflammation and improvement in plaque control over 6 months when using a new SnF2 dentifrice stabilized with nitrate and phosphates as compared to the results from a regular fluoride dentifrice.

PRACTICAL IMPLICATIONS

This newly formulated SnF2 dentifrice may be of benefit to patients who need help controlling plaque biofilm and in reducing gingivitis, leading to an improvement in overall oral health.

摘要

背景

本随机对照试验的目的是比较一种含有硝酸盐和磷酸盐稳定的氟化亚锡(SnF2)牙膏(试验组)与常规含氟牙膏(阴性对照组)在 6 个月内对菌斑和牙龈炎的控制效果。

方法

这项研究在加利福尼亚州洛马林达进行,共招募了 80 名成年参与者。在对研究人员和患者进行随机分组和双盲处理后,为入组参与者提供了使用指定牙膏的指导。在 3 次就诊(0、3 和 6 个月)时,收集了各种牙龈和菌斑指数,以确定 SnF2 稳定牙膏的临床疗效。这些结果与阴性对照组牙膏的结果进行了比较。

结果

共有 77 名参与者完成了这项研究。试验牙膏在使用产品 3 个月和 6 个月后,所有菌斑和牙龈炎指数与基线相比均有统计学显著降低。阴性对照组牙膏在使用产品 3 个月后,所有菌斑指数均显著低于基线,但牙龈炎指数除外,而在使用产品 6 个月后,所有菌斑和牙龈炎指数均显著低于基线,只有龈间炎指数未达到统计学显著水平。与基线相比,试验 SnF2 牙膏在使用产品 3 个月和 6 个月后,所有菌斑和牙龈炎指数均显著降低,与阴性对照组牙膏相比也有统计学显著差异(P 均小于 0.001)。

结论

这项临床试验的结果表明,与常规含氟牙膏相比,使用含有硝酸盐和磷酸盐稳定的氟化亚锡的新型 SnF2 牙膏在 6 个月内可更显著地改善牙龈炎炎症的临床疗效和菌斑控制效果。

实际意义

对于需要帮助控制菌斑生物膜和减少牙龈炎、从而改善整体口腔健康的患者,这种新配方的 SnF2 牙膏可能会有所帮助。

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