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临床试验/CTRI/2024/05/066578
CTRI/2024/05/066578尚未招募不适用

Evaluation of an innovative curved bristles toothbrush in dental plaque removal and on gingival health in children

DY Patil University School of dentistry Department of Pediatric and Preventive dentistry1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年5月10日最近更新:

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

发起方
DY Patil University School of dentistry Department of Pediatric and Preventive dentistry
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Diksha Patil

D Y Patil University School of Dentistry

研究点 (1)

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