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临床试验/NCT05868590
NCT05868590尚未招募不适用

Evaluation of Active Magnesium Containing Toothpaste on Dental Plaque in Children

Marmara University0 个研究点目标入组 50 人开始时间: 2023年5月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
主要终点
Active Magnesium Containing Toothpaste (ROCS)

研究概览

简要总结

The aim of this study is to compare the plaque reduction efficacy of toothpaste to a marketed active magnesium toothpaste with single-use brushing in children.Our study will consist of 50 people between the ages of 9-12. 50 people will take part in both toothpaste groups.

详细描述

The upper anterior incisor teeth of 50 children will be brushed with two different toothpaste in with a 2 week washout period.At the same time, the GC D lite Pro curing light will determine to differences in the amount of plaque by using detection mode and the differences amount of plaque on teeth will be recorded with using plaque dye.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
9 Years 至 12 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Patients aged 9-12 years
  • •The presence of caries-free and fully erupted upper anterior incisors that can be scored in the mouth
  • •Absence of orthodontic appliances/brackets
  • •No physical limitations
  • •No previous trauma history
  • •It was determined as the absence of soft-hard tissue pathology.

排除标准

  • •Patients not between 9-12 years
  • •The presence of decay and not fully erupted upper anterior incisors that can be scored in the mouth
  • •Presence of orthodontic appliances/brackets
  • •Physical limitations
  • •Previous trauma history
  • •It was determined as the presence of soft-hard tissue pathology.

研究组 & 干预措施

Active Magnesium Containing Toothpaste-ROCS

Experimental

The participants will ask not to eat for 4 hours and not to brush for 24 hours in advance of the test.In the first stage, the preliminary plaque in the children will record by the first researcher using plaque dye.After plaque disclosing the researcher brush children's teeth with ROCS active magnesium toothpaste for 1 minute with a standard toothbrush then the plaque staining will apply again.Also remaining plaque measurements will made using the Gc D lite Pro curring light on detection mode.Dental plaque on the upper anterior incisors will photograph intra-orally before and after brushing under standardized conditions.

干预措施: Toothpaste (Other)

Fluoride Toothpaste-COLGATE

Experimental

After 2 weeks, the same participants will ask not to eat for 4 hours and not to brush for 24 hours in advance of the retest.Initial, the preliminary plaque in the children will record by the first researcher using plaque dye. After plaque disclosing the researcher brush children's teeth with Colgate fluoride toothpaste for 1 minute with a standard toothbrush then the plaque staining will apply again.Also remaining plaque measurements will made using the Gc D lite Pro curring light on detection mode.Dental plaque on the upper anterior incisors will photograph intra-orally before and after brushing under standardized conditions.

干预措施: Toothpaste (Other)

结局指标

主要结局

Active Magnesium Containing Toothpaste (ROCS)

时间窗: 1 month

Active magnesium containing toothpaste can find to be effective in reducing plaque of Turesky-Modified Quinley-Hein-Plaque-Index (TMQHPI) score when compare to Fluoride toothpaste with single-use brushing in children

次要结局

未报告次要终点

研究者

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

Haner Direskeneli

Professor

Marmara University

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