一项评估新型含 0.1%w/w 香芹酚和 0.6%w/w 氯化锌牙膏维持牙龈健康的随机临床试验。
A randomised clinical trial to assess maintenance of gingival health by a novel dentifrice containing 0.1%w/w o-cymen-5-ol and 0.6%w/w zinc chloride.
机构信息
Global Health Research Group, New Delhi, India.
出版信息
Int Dent J. 2011 Aug;61 Suppl 3(Suppl 3):13-20. doi: 10.1111/j.1875-595X.2011.00044.x.
OBJECTIVES
To assess the ability of 0.1%w/w o-cymen-5-ol/ 0.6%w/w zinc chloride dentifrice to maintain gingival health compared to a sodium fluoride control dentifrice.
DESIGN
Following a baseline examination, subjects went through a regimen to bring them to a high level of gingival health. This included a professional prophylaxis supported by oral hygiene instruction prior to commencing study treatment. Subjects brushed twice daily for 12 weeks with either the test or control dentifrice. Examinations for gingival inflammation (MGI), bleeding and plaque were performed after 6 and 12 weeks.
RESULTS
224 subjects were included in the efficacy analysis. Relative to the sodium fluoride/ silica control dentifrice group the o-cymen-5-ol/ zinc chloride dentifrice exhibited statistically significant reductions (p<0.0001) in MGI, bleeding and plaque of 12.3%, 18.5% and 13.2% respectively after six weeks and 38.1%, 37.8% and 24.2% after 12 weeks.
CONCLUSION
The results of the present clinical study demonstrate that the use of the 0.1%w/w o-cymen-5-ol/ 0.6%w/w zinc chloride dentifrice over a 12 week period provides a statistically significant benefit in maintaining gingival health compared to a sodium fluoride control dentifrice.
目的
评估 0.1%w/w 香芹酚/0.6%w/w 氯化锌牙膏与含氟牙膏相比维持牙龈健康的能力。
设计
在基线检查后，受试者接受了一个方案，使他们达到高度的牙龈健康水平。这包括在开始研究治疗前进行专业的预防措施，并提供口腔卫生指导。受试者每天用试验或对照牙膏刷牙两次，持续 12 周。在第 6 周和第 12 周后进行牙龈炎症（MGI）、出血和菌斑检查。
结果
224 名受试者纳入疗效分析。与含氟/硅酸钠对照牙膏组相比，香芹酚/氯化锌牙膏在第 6 周时分别在 MGI、出血和菌斑方面显示出统计学上显著的减少（p<0.0001），分别为 12.3%、18.5%和 13.2%，在第 12 周时分别为 38.1%、37.8%和 24.2%。
结论
本临床研究的结果表明，使用 0.1%w/w 香芹酚/0.6%w/w 氯化锌牙膏 12 周，与含氟牙膏相比，在维持牙龈健康方面具有统计学上的显著益处。
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