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临床试验/NCT07563400
NCT07563400尚未招募不适用

Efficacy of Plaque Removal and Antibacterial Properties of Charcoal Infused Bristle Vs Nylon Bristle Toothbrushes in Children: A Randomized Clinical Trial

Cairo University0 个研究点目标入组 50 人开始时间: 2026年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
主要终点
Change in full-mouth plaque score assessed by O'Leary Plaque Control Index from baseline to 2 weeks

研究概览

简要总结

This study will compare two types of toothbrushes in children: a charcoal-infused bristle toothbrush and a regular nylon bristle toothbrush. We want to see which toothbrush is better at removing plaque and reducing bacteria in the mouth. Children will be randomly assigned to use one of the toothbrushes. We will measure the levels of bacteria in small samples of fluid taken from the gums to see if one toothbrush reduces harmful bacteria more than the other.

详细描述

This study is a clinical trial designed to compare the effectiveness of two types of toothbrushes in children aged 6-10. One group of children will use a toothbrush with charcoal-infused bristles, while the other group will use a standard nylon bristle toothbrush. All children will be taught the same brushing technique and will brush their teeth twice daily for two minutes using a pea-sized amount of toothpaste.The study will last two weeks. Researchers will measure four times how much dental plaque is removed from each child's teeth, collect samples from the gums to examine bacteria, and test the toothbrush bristles for bacterial contamination by counting bacterial colonies.The goal is to determine which toothbrush is better at cleaning teeth and reducing harmful bacteria in the mouth.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
6 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • ● Children aged 6 to 10 years.
  • Medically free patients with no physical disability.
  • Patients must have proper oral hygiene.
  • Cooperative patients who will comply with follow-ups.
  • Parents who accept to sign informed consent.

排除标准

  • ● Children with a medical condition or physical disability,
  • Children undergoing antibiotic treatment
  • Children with crowding, fixed or removable orthodontic appliances.
  • Children with pre-shedding mobile teeth were excluded from study.
  • Children who will be unable to attend follow-up visits.
  • Parents refuse to give written formed consent.
  • Presence of painful teeth.
  • Presence of active carious lesions

研究组 & 干预措施

Charcoal-Infused Bristle Toothbrush

Experimental

Children in this arm will use a soft charcoal-infused bristle toothbrush twice daily for two minutes each time, using a pea-sized amount of fluoride-free toothpaste (Dabur Herb'l, India). Participants will be trained in the horizontal scrub technique and instructed on proper toothbrush storage to minimize bacterial contamination.

干预措施: soft charcoal infused bristle toothbrush (iLive) with bamboo handle (Device)

Nylon Bristle Toothbrush

Active Comparator

Children in this arm will use a soft nylon bristle toothbrush twice daily for two minutes each time, using a pea-sized amount of fluoride-free toothpaste Participants will be trained in the horizontal scrub technique and instructed on proper toothbrush storage to minimize bacterial contamination.

干预措施: soft nylon bristle toothbrush (Oral B JUNIOR 6-12) (Device)

结局指标

主要结局

Change in full-mouth plaque score assessed by O'Leary Plaque Control Index from baseline to 2 weeks

时间窗: aseline, immediately after training, 1 week, and 2 weeks post-training

Full-mouth plaque score will be measured using the O'Leary Plaque Control Index at four time points: baseline (before training), immediately after training, one week, and two weeks post-training. Each tooth surface (mesial, distal, buccal, and lingual) will be examined. The plaque score will be expressed as the percentage of plaque-containing surfaces relative to the total number of surfaces examined

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mennatullah Yasser Sayed Abou El Enein

Principal Investigator

Cairo University

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