The Study of Parental Toothbrushing Efficacy Assessment With Triple-Headed and Single-Headed Toothbrushes in Preschool Children With Developmental Disability: A Randomized Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Dental Plaque Reduction Score Assessed by the Greene and Vermillion Plaque Index
研究概览
简要总结
The Objectives
- To evaluate the efficacy of dental plaque removal between triple-headed and single-headed toothbrushes in preschool children with developmental disabilities through parental brushing
- To assess the parental satisfaction with triple-headed toothbrushes
详细描述
This study was a single-blind, randomized crossover study. 24 Parents of children with developmental disabilities (DD) were invited to participate in the study. Baseline data including demographic information, plaque index, and dmft, were collected. Participants were randomly assigned to receive their first toothbrush, either a single-head toothbrush (Berman®; soft and flat bristles for preschool children) or a triple-head toothbrush (Dr. Barman's Superbrush®; soft and flat bristles, size 0-6 years). Parents received toothbrushing instruction via a video clip according to the randomly assigned sequence of toothbrush type. Parents were then allowed to perform toothbrushing for their children. The quality of toothbrushing performance for each sextant was evaluated by the examiner using a toothbrushing performance form. Overall toothbrushing time was also recorded.
All participants were advised to use their own toothbrush during the washout period. After a four-week washout period, participants crossed over to the alternate toothbrush type, and all procedures were repeated. At the end of the study, parents completed a satisfaction questionnaire regarding the triple-headed toothbrush.
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
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Developmental disability children aged 3 to 6 years old who have full primary dentition.
- •The caregivers who responsible for brushing their child's teeth that must be the same person throughout the study and able to attend both study sessions
排除标准
- •Developmental disability children who have periodontal disease, soft tissue ulcers or gingival abscess.
- •Developmental disability children who have missing tooth more than one tooth per sextant.
- •Developmental disability children who have definitely negative behavior (Frankl behavior rating scale one) (89) during oral examination
- •Parents of Developmental disability children who have a physical or mental disability which may influence to their brushing ability.
研究组 & 干预措施
Triple and single headed toothbrush
Crossover study compared effectiveness of tripled and single headed toothbrush
干预措施: Triple-headed toothbrush (Device)
结局指标
主要结局
Dental Plaque Reduction Score Assessed by the Greene and Vermillion Plaque Index
时间窗: 4 weeks per participant
Dental plaque removal efficacy was assessed by the change in dental plaque scores measured using the Greene and Vermillion Plaque Index (score range: 0-3). Dental plaque was disclosed using Disclosing PCA 260 Liquid Solution (Curaprox, Switzerland) and evaluated on the labial/buccal and lingual/palatal surfaces of six primary teeth (teeth no. 51, 55, 65, 71, 75, and 85). Dental plaque scores were recorded immediately before and immediately after parent-performed toothbrushing using either a triple-headed toothbrush or a single-headed toothbrush, according to a randomized crossover design. The outcome measure was calculated as the difference between pre-brushing and post-brushing plaque index scores for each toothbrush type. Mean plaque score changes were compared between toothbrush types. A randomized crossover design with a four-week washout period was used to minimize carryover effects. Brushing time (in seconds) was recorded as a secondary parameter to support interpretation of pla
次要结局
- Parental Satisfaction With the Use of a Triple-Headed Toothbrush(4 weeks per participant)
研究者
Jantra Jitngamkusol
Principal Investigator
Mahidol University