Evaluation of an innovative curved bristles toothbrush in dental plaque removal and on gingival health in children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1.Plaque removal efficacy using-Turesky’s modification of Quigley Hein plaque index
研究概览
简要总结
Introduction:
Effective toothbrushing allows removal of dental biofilm, reducing the risk for dental caries and gingivitis. Factors influencing effective toothbrushing in children include correct toothbrushing methods, frequency, duration and toothbrush design. Several modifications of manual toothbrushes are developed to enhance mechanical removal of dental biofilm in children. The basic shape of manual toothbrushes remains same, while minor changes in handle design, bristle material and arrangement have been studied extensively. Recently, a toothbrush with an innovative bristle design has been introduced, claiming to efficiently remove plaque and reduce gingival inflammation.
Aim:
To evaluate plaque removal efficacy and gingival health using Collis curve toothbrush in comparison to conventional manual toothbrush in children between age 8 and 10 years.
Methodology:
A randomized controlled trial of 60 children between age 8 and 10 years who had good systemic health, normal motor and cognitive development and twice daily toothbrushing habit were included. DMFT was recorded for each child. Gingival scores and plaque scores were recorded using Loe and Silness gingival index and Turesky’s modification of Quigley and Hein plaque index (TQHI). The selected children were randomly assigned to manual toothbrush group (MT) and Collis curve toothbrush group (CT). They were instructed to use the respective toothbrushes for a duration of 3 weeks after which gingival index and plaque index were re-recorded. The mean score difference was used to determine the gingival health and plaque removal efficacy of the respective toothbrushes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 8.00 Year(s) 至 10.00 Year(s)(—)
- 性别
- All
入选标准
- •Children without any systemic diseases
- •Children with normal motor and cognitive development
- •Children who brush their teeth twice daily
- •Children using no other means of oral hygiene except tooth brushing.
排除标准
- •Children with history of antibiotic therapy in past one-month
- •Children who have undergone oral prophylaxis in past one-month
- •Children with deep carious lesions and fixed orthodontic appliances.
结局指标
主要结局
1.Plaque removal efficacy using-Turesky’s modification of Quigley Hein plaque index
时间窗: At baseline and after 3 weeks
2.Gingival health using Loe and Silness Gingival index
时间窗: At baseline and after 3 weeks
次要结局
未报告次要终点
研究者
Dr Diksha Patil
D Y Patil University School of Dentistry
