Evaluation of Oral and Dental Hygiene in Individuals With Special Needs Between 6 to 12 Years of Age
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 6
- 主要终点
- Change from baseline in Saliva Check mutans test at 52 weeks
研究概览
简要总结
This clinical trial aims to learn about the general oral hygiene status of children with special needs and test the effect of hygiene education on their oral and dental hygiene. The main questions it aims to answer are:
- What is the general oral hygiene status of children with special needs?
- Does brushing education and dietary guidance to parents improve oral and dental hygiene in children with special needs? Participants will receive a complete oral and dental examination. Following this examination parents/legal guardians will be educated about the maintenance of oral and dental hygiene and dietary guidance will be provided. Patients will be evaluated one year after the education
详细描述
One hundred and thirty children with special needs who are being rehabilitated at three rehabilitation centers (Maviel, Sirinler and Ugurlu Kalpler Rehabilitation Centers) in Kilis will undergo a complete oral and dental examination at which their oral bacteria (str. mutans) levels, PUFA and plaque indexes (indices that measure oral health) will be recorded. The parents/legal guardians of the children will be educated about dental hygiene toothbrushing and dietary habits leading to caries. After a year, the examination and assessments will be repeated. The change in oral hygiene indices will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with special needs
- •Aged between 6-12 years
排除标准
- •Being unable to complete oral examination due to lack of cooperation
结局指标
主要结局
Change from baseline in Saliva Check mutans test at 52 weeks
时间窗: Baseline and 1 year after the education
A speed test of specific bacteria named streptococcus mutans, which plays a leading role in caries formation, from patients' collected saliva. Interpreted from the strips as high, low levels of bacteria or no bacteria in saliva.
Change from baseline on the 5 point plaque index at 52 weeks
时间窗: Baseline and 1 year after the education
An assessment of the amount of dental plaque visible on the vestibular and lingual surfaces of all teeth. Possible scores range from 0 (no plaque) to 4 (considerable plaque film formation)
Change from baseline in the number of teeth with each element of PUFA index at 52 weeks
时间窗: Baseline and 1 year after the education
An assessment of the presence of oral conditions resulting from untreated caries. P=Pulpal involvement, U=ulceration, F=fistula, A=abscess index.
次要结局
未报告次要终点
研究者
Mine Tirnaksiz
Principal Investigator
Altinbas University