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临床试验/NCT07365748
NCT07365748已完成不适用

Evaluation of Bacterial Contamination and Antimicrobial Efficacy on Charcoal-Infused vs, Standard Nylon Toothbrush Bristles.

MTI University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年11月11日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
Colony-forming units (CFU)

研究概览

简要总结

This study compares two types of toothbrushes to see which one stays cleaner after use. Researchers want to know if toothbrushes with charcoal-infused bristles have fewer bacteria than standard toothbrushes with nylon bristles.

Participants in this study are adults and children who do not have gum disease or other major health issues. Everyone in the study will be assigned one of two types of toothbrushes:

  • An eco-friendly toothbrush with charcoal bristles.
  • A standard toothbrush with nylon bristles. Participants will use their assigned toothbrush at home for two specific time periods (one day and one week). They will follow simple instructions on how to brush and store the toothbrush. After each time period, they will return the toothbrush to the researchers.

The research team will test the bristles in a lab to count the bacteria. They will also measure how well the charcoal bristles stop bacteria from growing compared to the nylon bristles. This will help determine if charcoal toothbrushes are a more sanitary and eco-friendly option for daily oral care.

详细描述

Study Design and Randomization This study employs a randomized, parallel-group, ex-vivo microbiological design to assess bacterial retention and antimicrobial efficacy. Participants are stratified by age (children and adults) and randomized to receive either an eco-friendly charcoal-infused toothbrush or a standard nylon toothbrush. Allocation is managed using computer-generated random sequences concealed in sequentially numbered, opaque envelopes. To maintain blinding, laboratory outcome assessors are unaware of group assignment, and participants are instructed not to disclose their intervention to the assessment team.

Standardized Usage Protocol

To minimize variability in bacterial load due to behavioral factors, all participants adhere to a strict hygiene protocol:

  • Brushing Technique: Participants brush twice daily (morning and evening) for two minutes using a standardized method (45-degree angle to the gingiva with short back-and-forth strokes, and vertical strokes for anterior lingual surfaces).
  • Storage and Maintenance: Post-brushing, bristles are rinsed under running water without digital manipulation. Toothbrushes must be stored upright, uncovered, and positioned at least two feet away from sanitary fixtures (e.g., toilets) to minimize aerosol contamination.
  • Restrictions: The use of antimicrobial mouthrinses, medicated toothpastes, or bristle covers is prohibited during the active study phases.

Sample Collection Timeline

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)

入排标准

年龄范围
8 Years 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Participants free of any systemic diseases.
  • Participants falling into one of two specific age groups:
  • A) Children aged 8 to 11 years.
  • B) Adults aged 18 to 35 years.
  • Willingness to use the assigned toothbrush type (Eco-friendly charcoal or standard nylon).
  • Ability to follow study instructions regarding brushing technique and storage.

排除标准

  • Patients with open carious lesions.
  • Participants with poor oral hygiene, defined as plaque index scores greater than
  • Participants with severe gingivitis, defined as gingival index score greater than
  • Current throat infections.
  • Irregular brushing frequency (not brushing twice daily).
  • Current use of mouthwash or antibacterial toothpastes.
  • Current smokers.
  • Medically compromised individuals.
  • Unwillingness to use a charcoal Eco-friendly toothbrush.

研究组 & 干预措施

Antimicrobial effect of Eco-friendly tooth brush in children

Experimental

this arm will use the Eco-friendly toothbrush and will be evaluated for its antimicrobial effect

干预措施: Eco-friendly toothbrush for children (Device)

Antimicrobial effect of Eco-friendly tooth brush in adults

Experimental

this arm will use the eco-friendly toothbrush and tested for its antimicrobial effect in adults

干预措施: Eco-friendly toothbrush in adults (Device)

Nylon bristles toothbrush in children

Active Comparator

this arm will use the nylon toothbrush bristles and be evaluated for its antibacterial effect

干预措施: nylon bristles toothbrush in children (Device)

nylon toothbrush bristles in adults

Active Comparator

this arm will use the nylon bristles toothbrush and be evaluated for its antimicrobial effect

干预措施: Nylon bristles toothbrush in adults (Device)

结局指标

主要结局

Colony-forming units (CFU)

时间窗: 10 days

Bacterial load will be quantified as CFU per milliliter (CFU/mL) from toothbrush bristles after 1 day and 1 week of use. One-third of the bristles will be aseptically cut, placed in 5 mL sterile saline, mixed to elute bacteria, then 0.1 mL will be plated onto blood agar. Plates will be incubated under anaerobic conditions for 48 hours, then colonies will be counted and recorded as CFU/mL.

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

Esraa Hamed Aly

Lecturer of Pediatric Dentistry & Dental Public Health at MTI University

MTI University

研究点 (1)

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