"Comparing the Plaque Removal Ability of Triple Head Tooth Brush Versus Single Head Tooth Brush Among School Based Cerebral Palsy Children:A Randomized Control Trial"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Plaque Index Score
研究概览
简要总结
It was an intervention utilizing two toothbrushes on school going cerebral palsy children age (6 -18 yrs). The triple head tooth brush and single head brush was provided to parents along with dental health education to their parent on brushing technique and oral care for their child. Parents who give consent for their child were enrolled in the study. The plaque removal ability of toothbrush was assessed by Turesky modified Quigley Hein index. The reading for plaque score was recorded at base line and after the follow up of 4 weeks. Difficulties during brushing was also analyzed.
详细描述
Study Design :Single blinded Randomized Control Trial
Study Setting: The study was conducted in schools that have cerebral palsy children in Karachi.
Study Duration :From June 2021 to June 2022.
Sampling technique: Non probability purposive sampling technique was used for selection of study population.
Sample Size: Total 58 individuals were recruited in the study. After including the 20% drop out rate 35 subjects were enrolled at each study group which make total sample size of 70 Cerebral Palsy participants. Random allocation was made in two groups in order to keep the sizes of intervention groups similar.
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
- Single (Investigator)
盲法说明
The dental investigator who perform the oral health assessment for dentition status and plaque status was blinded during the intervention.
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
- 是
入选标准
- •• Parents who give consent to enrol in study and their children (age: 6-18yrs) who cooperate to allow to perform oral assessment.
排除标准
- •• Children unable to cooperate due to underlying systematic condition because of their motor and mental illness.
结局指标
主要结局
Plaque Index Score
时间窗: Before and after the intervention of four weeks
Plaque score was recorded through Turesky modified Quigley Hein Index to observe improvement in plaque score before and after the intervention.
Difficulties associated with toothbrushing e.g Bleeding during brushing, gag reflex, enable reaching more teeth and time required for brushing.
时间窗: At postintervention after four weeks.
次要结局
- DMFT/dmft index(At Baseline)
- Oral Hygiene Behavior e.g. brushing frequency, complain of pain and visit to a dentist during last 12 months(At Baseline)
研究者
Zainab Jahanzeb
Principal Investigator
Dow University of Health Sciences