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临床试验/NCT01578603
NCT01578603已完成4 期

Effects of Two Sugar Substituted Chewing Gums Plus Tooth Brushing on Different Caries and Gingivitis Related Variables: a Double Blind, Randomized Controlled Clinical Trial

Universidad de Antioquia1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
130
试验地点
1
主要终点
Turesky index

研究概览

简要总结

The purpose of this study is to determine the effect of three times a day mastication, during a follow-up period of 4 weeks, of two sugar-substituted chewing gums on various factors associated with dental caries and gingivitis.

详细描述

The purpose of this paper is to compare the effect of daily consumption of two sugar-free chewing gum, one with Recaldent and one with Xylitol, added to traditional hygiene (brushing, fluoridated toothpaste and dental floss), in clinical features such as the accumulation of plaque and gingival inflammation, microbiological characteristics of saliva as the counts of cariogenic microorganisms and facultative anaerobes, and some physicochemical properties of saliva such as pH and concentrations of calcium and inorganic phosphate.

To this there was a general call among dental students at the University of Antioquia and those who expressed their intention to participate voluntarily with informed consent, were examined clinically and randomly assigned to one of the study groups (Recaldent or Xylitol) or the control group.

After a month of baseline examination and the daily use of the same instruments of oral hygiene and chewing of 6 pellets of each chewing gum (in the case of study groups), all variables are re-examined.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 34 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • systemically healthy
  • dental student

排除标准

  • less than 26 teeth in mouth
  • use of orthodontic appliances
  • use of antibiotics the last 3 months

结局指标

主要结局

Turesky index

时间窗: a month

dental plaque assessment

次要结局

  • Gingival index(a month)
  • salivary pH(a month)
  • Streptococcus mutans(a month)
  • Ca levels(a month)
  • facultative microorganisms(a month)
  • Lactobacillus(a month)
  • phosphate levels(a month)
  • BOP index(a month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

María Cecilia Martínez-Pabón

Profesora Asociada

Universidad de Antioquia

研究点 (1)

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