Identification of Effective Fluoride Concentration In Toothpaste For Dental Caries Prevention; A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 380
- 试验地点
- 2
- 主要终点
- changes in DMFT (decayed, missing filled teeth) scores, over a period of 18 months.
研究概览
简要总结
to identify the Effective Fluoride Concentration In Toothpaste For Dental Caries Prevention after 18 months of randomized controlled trial.
详细描述
In developed countries, well-controlled clinical trials have investigated the effective fluoride level in toothpaste and provided irresistible data in relation to the caries controlling efficacy of tooth pastes. But there has been no such data reported in our part of the world. This indicates the need to determine the effective concentration of fluoride in locally manufactured tooth pastes for accomplishment of the goal of prevention against dental caries.
This will be a Parallel Group, Double-Blind, Randomized Controlled Trial, over a period of 18 months. The study will be conducted in a randomly selected school of Karachi city. Participants will be the cohort of regular school children aged 12-14 years. Sample size for the present study attained was 330 (165 in both groups), expected attrition rate will be kept as 15%, so the total sample size is 330 + 50 = 380 (190 in each group).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Regular school children of 12-15 years
- •Presence of at least four molars
排除标准
- •Non- consenting cases
- •Medically/physically compromised children
- •Children under any kind of parallel fluoride regime (systemic or topical)
- •Children consuming diet that is different from routine dietary practices
- •Children using toothpaste with greater than 1100 ppm and less than 500 ppm of fluoride
- •Children found with rampant caries
- •Children found with all filled molars
- •Children with any oral infection abscess, periodontitis etc
- •Dentition with malocclusion
- •Children undergoing orthodontic/prosthodontic treatment
- •Children with Temporo mandibular joint disorder
- •Children who missed the baseline examinations
- •Loss to any follow-up cases
结局指标
主要结局
changes in DMFT (decayed, missing filled teeth) scores, over a period of 18 months.
时间窗: 18 months
次要结局
未报告次要终点
研究者
DRAEEZA MALIK
dr.
Dow University of Health Sciences