Evaluating the Effectiveness of Different Toothbrushes in Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque removal
研究概览
简要总结
Control groups will be formed in the 2-12 age group using standard manual toothbrushes, and the effectiveness of 360-degree bristle toothbrushes will be compared.
Study design: Experimental study
详细描述
In this randomized controlled, single-brushing study, children were assigned to a treatment sequence involving a 360-degree toothbrush and a control brush.
Subjects were randomly assigned to a treatment sequence involving a 360-degree toothbrush and a classical manual control toothbrush. Parents brushed the teeth of their children aged 2-5 years, whereas children aged 6-12 years brushed their own teeth under the supervision of clinic staff, unaided by a mirror. Clinical examination of each participant was carried out by the principal investigator. Assessments were done pre- and post-brushing using the "Silness and Löe Plaque Index" (PI), Gingival Index (GI), and the Simplified Oral Hygiene Index (OHI-S). Plaque indices were expressed as means and standard deviations (SD). Within each toothbrush group, the follow-up scores were analyzed using a paired t-test. p < 0.05 was considered statistically significant.
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 performed the oral health assessment for dentition status and plaque status was blinded during the intervention.
入排标准
- 年龄范围
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children aged 2-
- •Children without systemic disease or developmental dental anomalies.
- •Children not undergoing orthodontic treatment.
- •Children with no decay on the labial surfaces of upper anterior incisors.
- •Patients or their parents accepting participation in the treatment.
排除标准
- •Children with decay on the labial surfaces of upper anterior incisors.
- •Children undergoing orthodontic treatment.
- •Children who, along with their parents, do not agree to participate in the treatment will be excluded from the study.
研究组 & 干预措施
control group
A control group will be formed using a manual brush with a classic head.
干预措施: standart manual toothbrush (Device)
study group
A study group will be formed using a 360-degree bristle brush.
干预措施: 360 degree toothbrush (Device)
结局指标
主要结局
Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque removal
时间窗: 2 weeks
Mean Change from baseline (pre-brushing to post-brushing) in plaque score after single supervised use based on all surfaces of the whole mouth measured.
次要结局
未报告次要终点