Comparative Efficacy of Triple Headed toothbrush and Conventional single headed toothbrush in Reducing Plaque and Gingivitis in children and Adolescents with autism: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Implementing a triple-headed toothbrush in oral hygiene routines for children with autism can lead to more efficient and effective brushing, potentially improving both oral health and overall willingness to participate in brushing activities compared to conventional toothbrush.
研究概览
简要总结
Primary Purpose of the Protocol:The primary purpose of this protocol is to assess the efficacy of triple-headed toothbrushes compared to conventional single-headed toothbrushes in reducing plaque and gingivitis among children and adolescents with autism spectrum disorder (ASD). The randomized controlled trial aims to determine if the triple-headed toothbrush can provide superior oral hygiene outcomes, addressing the unique brushing challenges faced by individuals with ASD.
Study Hypothesis:
The triple-headed toothbrush is significantly more effective in reducing plaque and gingivitis in children and adolescents with autism compared to the conventional single-headed toothbrush.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 7.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Children with Autism Spectrum Disorder in the age range of 7 to 18 years who are attending special schools for children with autism in Belagavi, Karnataka, India 2) Children diagnosed with autism spectrum disorder, permanent or mixed dentition, cooperative children, and caregivers of children who assented and signed informed consent to participate in the study.
排除标准
- •Children with visual impairment, other special needs or challenges, and underlying systemic diseases, those with Frankl scale score less than 2 and uncooperative behavior, and other special health care needs, children who have received oral health education and treatment sessions in the last 12 weeks.
结局指标
主要结局
Implementing a triple-headed toothbrush in oral hygiene routines for children with autism can lead to more efficient and effective brushing, potentially improving both oral health and overall willingness to participate in brushing activities compared to conventional toothbrush.
时间窗: Participants will receive their assigned toothbrushes along with toothpaste at the start of the intervention phase. They will be instructed to brush twice daily under the supervision of their caregivers for a specified period 3 months. Follow-up visits will be scheduled 7th, 21st and 45th day to monitor compliance with the brushing regimen, reinforce proper brushing techniques, and address any issues that may arise during the study.
次要结局
- 1) Measure the time taken for each brushing session to assess if the triple-headed toothbrush reduces the time needed compared to the conventional single-headed toothbrush.(2) Evaluate the acceptability, comfort, and ease of use of the triple-headed toothbrush among children and adolescents with autism through feedback from participants and caregivers.)
研究者
Biswadeep Roychowdhury
KLE VK INSTITUTE OF DENTAL SCIENCES, Belgaum