跳至主要内容
临床试验/CTRI/2010/091/001334
CTRI/2010/091/001334未知不适用

A comparison of anticaries efficacy of 0.2% sodium fluoride mouthrinse with and without xylitol and tirclosan : a residential school based clinical trial

JSS University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 待定

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Plaque will be disclosed with a disclosing agent and the surfaces of the index tooth will be assessed using the Turskey et.al. modification (1970) of the Quigley & Hein plaque index (1962). Gingival index (Loe & Silness) will be used to evaluate gingivitis.Dental caries recording

研究概览

简要总结

The clinical trial will be conducted and completed in 2011 at JSS Free residential school, Suttur,Mysore Dist.India A total of 100 children (50 girls & 50 boys) aged between 8 and 10 years studyng at the JSS Free Residential school in Suttur will be selected and divided into Xylitol containing fluoridated+triclosan mouthrinse (0.2% ,904 ppm F) test (50 children) and conventional fluoridated mouthrinse (0.2% ,904 ppm F) control (50children) groups. Rinsing will be with 10 ml mouthrinse solution for 2 minutes in both groups . Both the groups shall be on 1000 ppm fluoridated dentifrice and toothbrushing with roll stroke method during the study period. They will further be stratified according to age, gender, and dental caries status. After the washout period of three days, the selected children will be examined initially for plaque ,gingivitis and caries before the start of the study and later on the examination shall be carried out at 7 and 21 days for plaque and gingivitis and at 6 months and 12 months for assessment of plaque gingivitis and dental caries. The mean plaque ,gingival scores and caries recording of the subjects who complete the study in these groups shall be done in both the groups. Comparison between the two groups will reveal whether the Xylitol containing sodium fluoride+triclosan mouthrinse is more effective in inhibiting the progression of plaque and gingivitis and dental caries compared to the conventional fluoridated mouthrinse at a residential school mouthrinsing programme.

研究设计

研究类型
Observational

入排标准

年龄范围
12.00 Year(s) 至 13.00 Year(s)(—)
性别
All

入选标准

  • 1.Children between 12 to 13 years of age.
  • 2.All teeth should be present for that age group and fully erupted.
  • 3.At baseline, children having plaque index ≥
  • 4.Informed consent from the concerned person.

排除标准

  • 1.Children who have undergone recent antibiotic therapy, suffering from chronic medical conditions ,on long term medication2.History of early onset periodontitis, ANUG, gross oral pathology.
  • 3.Patients on orthodontic treatment..

结局指标

主要结局

Plaque will be disclosed with a disclosing agent and the surfaces of the index tooth will be assessed using the Turskey et.al. modification (1970) of the Quigley & Hein plaque index (1962). Gingival index (Loe & Silness) will be used to evaluate gingivitis.Dental caries recording

时间窗: The Comparison of results at 0 and 21 days for plaque and gingivitis and at 0 and 12 months for dental caries status.

次要结局

  • Plaque will be disclosed with a disclosing agent and the surfaces of the index tooth will be assessed using the Turskey et.al. modification (1970) of the Quigley & Hein plaque index (1962). Gingival index (Loe & Silness) will be used to evaluate gingivitis.Dental caries recording.(The Comparison of results at 0,7 and 21 days for plaque and gingivitis and at 0, 6 and 12 months for dental caries status.)

研究者

申办方类型
Other [university]

研究点 (1)

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