Effectiveness of Eco-Friendly Toothbrush Compared to Nylon-Based Toothbrush on Cariogram Parameters in Children and Adults: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Caries risk profile determined by cariogram
研究概览
简要总结
The goal of this clinical trial is to evaluate the effectiveness of an eco-friendly toothbrush compared to a conventional nylon-based toothbrush on cariogram parameters in children and adults. It will also assess the impact of toothbrush type on caries risk factors. The main questions it aims to answer are:
Does the use of an eco-friendly toothbrush improve cariogram parameters compared to a nylon-based toothbrush? Does toothbrush type influence overall caries risk in children and adults?
Participants will:
- Be randomly assigned to use either an eco-friendly toothbrush or a nylon-based toothbrush
- Use the assigned toothbrush as part of their daily oral hygiene routine for the study period
- Attend scheduled follow-up visits for clinical examination and cariogram assessment
详细描述
This study is a randomized controlled clinical trial designed to compare the effects of an eco-friendly toothbrush and a conventional nylon-based toothbrush on cariogram parameters in children and adults. Eligible participants will be classified by age group and randomly allocated into two intervention groups. At baseline, all participants will undergo clinical examination and caries risk assessment using the Cariogram model. Standardized oral hygiene instructions will be provided to all participants. Participants in each group will use the assigned toothbrush exclusively throughout the study period.
Follow-up assessments will be conducted at predetermined intervals to evaluate changes in cariogram parameters. Compliance with toothbrush use will be monitored during follow-up visits.
The primary outcome is the change in cariogram parameters from baseline to the end of the study period. Secondary outcomes include differences in overall caries risk profile between the two toothbrush groups and between age categories. Data will be analyzed to compare the effects of toothbrush type on cariogram outcomes while accounting for age-related differences
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Months 至 35 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children's age group: Participants must be within the age range of 8 to 11 years.
- •This age group is specifically chosen due to the prevalence of mixed dentition, which presents unique challenges and considerations for oral hygiene practices and assessment, and is considered as being a high caries risk profile according to the cariogram parameters. (Tavargeri & Banerjee, 2021)(Lodha, Saraf, & Jawdekar, 2023) Adults' age Group: Participants must be within the age range of 18 to 35 years consider as being a high caries risk profile according to the cariogram parameters.
- •(AlDhawi et al., 2020; Fageeh et al., 2024) and (Fouad et al., 2022)
排除标准
- •For the children's age group:
- •Lack of parental/guardian consent for participation.
- •Currently undergoing orthodontic treatment (fixed or removable appliances).
- •Children with special healthcare needs or those who are physically unwell at the time of the study.
- •Receipt of professional dental prophylaxis within the previous 3 months.(Tavargeri & Banerjee, 2021)
- •Patient with a cariogenic diet.(Fouad et al., 2022)
- •For the adult group:
- •Currently undergoing orthodontic treatment (fixed or removable appliances).
- •Individuals with physical disabilities or any systemic health conditions (e.g.,
- •diabetes) that could influence oral health or the ability to perform oral hygiene effectively.
- •Receipt of professional dental prophylaxis (e.g., scaling and polishing) within the previous 3 months.(Fageeh et al., 2024)
- •Patients with a cariogenic diet. (Fouad et al., 2022)
研究组 & 干预措施
Children age group
children will be randomly assigned to one of the two subgroups accoridng to the type of tooth brushes used
干预措施: Nylon based tooth brush (Other)
Children age group
children will be randomly assigned to one of the two subgroups accoridng to the type of tooth brushes used
干预措施: Ecofriendly toothbrush (Other)
Adults age group
Adults will be randomly assigned to one of the two subgroups accoridng to the type of tooth brushes used
干预措施: Nylon based tooth brush (Other)
Adults age group
Adults will be randomly assigned to one of the two subgroups accoridng to the type of tooth brushes used
干预措施: Ecofriendly toothbrush (Other)
结局指标
主要结局
Caries risk profile determined by cariogram
时间窗: 6 months follow up
it determines if the patient is high, moderate and low caries risk after the study
次要结局
未报告次要终点
研究者
Raneen Ahmed
Lecturer at operative department
Suez University