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ProBiora3 益生菌漱口水人体安全性和有效性的初步评估

Preliminary assessment of safety and effectiveness in humans of ProBiora3, a probiotic mouthwash.

机构信息

Oragenics Inc., Alachua, FL 32615, USA.

出版信息

J Appl Microbiol. 2009 Aug;107(2):682-90. doi: 10.1111/j.1365-2672.2009.04243.x. Epub 2009 Mar 30.

DOI:10.1111/j.1365-2672.2009.04243.x
PMID:19486429
Abstract

AIMS

To conduct a pilot human clinical trial to assess the safety and to test the ability of a probiotic mouthwash, ProBiora(3), to affect the levels of Streptococcus mutans and certain known periodontal pathogens in the mouth when administered twice daily over a period of 4 weeks.

METHODS AND RESULTS

The mouthwash contained three specific strains of naturally occurring oral bacteria and was tested at two dose levels: 10(6) and 10(8) colony forming units each of Strep. oralis strain KJ3sm, Strep. uberis strain KJ2sm, and the spontaneous lactic acid-deficient variant of Strep. rattus, strain JH145. Substantial decreases in the levels of the marker bacteria were observed. No safety issues were noted with the twice daily application of this mouthwash.

CONCLUSIONS

Despite the small number of subjects and the use of young, orally healthy adults, along with the inherent variability in the microbiological measurements, the probiotic mouthwash was able to substantially affect the levels of dental pathogens in saliva and periodontal pathogens in subgingival plaque.

SIGNIFICANCE AND IMPACT OF THE STUDY

The results of this pilot human study suggest that the probiotic mouthwash product may be safe for daily use as an aid in maintaining both dental and periodontal health.

摘要

目的

进行一项人体临床试验,以评估一种益生菌漱口水 ProBiora(3) 的安全性,并测试其在 4 周内每天使用两次时影响口腔中变异链球菌和某些已知牙周病原体水平的能力。

方法和结果

该漱口水含有三种特定的天然口腔细菌菌株,以两种剂量水平进行测试:10(6)和 10(8)个菌落形成单位的口腔链球菌 KJ3sm 株、口腔乳杆菌 KJ2sm 株和自发缺乏乳酸的鼠链球菌 JH145 变异株。观察到标记细菌的水平显著下降。这种漱口水每天使用两次,未发现安全问题。

结论

尽管研究对象数量较少,且使用了年轻、口腔健康的成年人,以及微生物测量固有的可变性,但益生菌漱口水能够显著影响唾液中的牙病病原体和牙周病病原体在龈下菌斑中的水平。

研究的意义和影响

这项人体初步研究的结果表明,该益生菌漱口水产品可能安全,可作为日常使用的辅助手段,有助于维持口腔和牙周健康。

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