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临床试验/NCT03234231
NCT03234231Unknown不适用

Supervised Toothbrushing Programme and Oral Health Education for Intellectual Disabled Students: A Cluster Randomised Controlled Trial

MD Equation0 个研究点目标入组 602 人开始时间: 2018年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
602
主要终点
Gingivitis score

研究概览

简要总结

Intellectual disabled persons faced more dental problems. According to a medical review paper of international and local studies, this group has poorer dental hygiene, more severe gum disease and more untreated caries. In 2010, a report from the guardians in Hong Kong mentioned that most adults with intellectual disability cannot clean their teeth, the have dental problems and it is very difficult for intellectually disabled students to co-operate during the dental treatment. In order to alleviate their dental problems, supervised toothbrushing programme and an oral health education talk are proposed. The investigators investigate the effectiveness of the supervised toothbrushing programme and an oral health education talk. The target group of the study is mild to moderate grade intellectual disabled students of special schools in Hong Kong. A clustered randomised controlled trial design is adopted.

详细描述

Intellectual disabled persons faced more dental problems. According to a medical review paper of international and local studies, this group has poorer dental hygiene, more severe gum disease and more untreated caries. In 2010, a report from the guardians in Hong Kong mentioned that most adults with intellectual disability cannot clean their teeth, the have dental problems and it is very difficult for intellectually disabled students to co-operate during the dental treatment. In order to alleviate their dental problems, supervised toothbrushing programme and an oral health education talk are proposed. The investigators investigate the effectiveness of the supervised toothbrushing programme and an oral health education talk. The target group of the study is mild to moderate grade intellectual disabled students of special schools in Hong Kong. A clustered randomised controlled trial design is adopted.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

data entered by independent clerical staff with no information of the detail of the study outcomes assessor will not be told which group of subjects are examined but there is a chance that the subjects tell him/her

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Mild and moderate grade intellectual disabled students in special schools.

排除标准

  • Those students who have simultaneously joined other oral health programme during the study period.
  • Those students with the presence of conditions rendering a need of antibiotic prophylaxis prior to periodontal examination e.g. rheumatic heart disease.
  • Uncooperative students that oral examination is not possible.

研究组 & 干预措施

Control Group

No Intervention

This group receive nothing during the study period.

Intervention Group

Experimental

A 3-month supervised tooth brushing programme will be provided to the students. An oral health education talk with written material delivered to the carers and the students

干预措施: 3-month supervised tooth brushing programme (Behavioral)

Intervention Group

Experimental

A 3-month supervised tooth brushing programme will be provided to the students. An oral health education talk with written material delivered to the carers and the students

干预措施: oral health education talk (Behavioral)

结局指标

主要结局

Gingivitis score

时间窗: A study period of 3 months

Measuring the change of oral conditions of the students

次要结局

  • Plaque score(A study period of 3 months)

研究者

发起方
MD Equation
申办方类型
Industry
责任方
Principal Investigator
主要研究者

Cecilia Young

Founder

MD Equation

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