Antimicrobial Efficacy of Charcoal-impregnated Toothbrushes: a Randomized Controlled Clinical Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Reduction of microbial contamination on toothbrush bristles
研究概览
简要总结
This randomized controlled clinical trial aims to evaluate the antibacterial effectiveness of toothbrushes with charcoal-impregnated bristles compared to conventional toothbrushes without charcoal. The main objective is to assess and compare the microbial contamination on the toothbrushes after 21 days of use.
Thirty-two healthy dental students from the Faculty of Dental Medicine of Rabat (16 males and 16 females, aged 18-24) were enrolled through convenience sampling. Participants were randomly assigned to two groups:
Group A: Colgate Double Action Medium toothbrushes with charcoal-impregnated bristles.
Group B: Colgate Double Action Medium toothbrushes without charcoal (control group).
Participants brushed their teeth twice daily for two minutes using the rolling technique and a standardized fluoride toothpaste (1450 ppm). They were instructed not to use mouthwash or antiseptic toothpaste, to rinse brushes only with tap water (without touching the bristles), to store them vertically with bristles facing upward, and to keep them uncovered and at least one meter away from toilets.
After 21 days, used toothbrushes were collected in sterile pouches and transferred to the microbiology laboratory. A quarter of the bristles from each brush head was aseptically cut, immersed in sterile saline solution, and vortexed to dislodge microorganisms. Aliquots of 200 µL were inoculated onto blood agar (Columbia agar base enriched with sterile blood). After incubation at 37°C for 48 hours, colony-forming units (CFU) were manually counted to estimate microbial contamination levels (CFU/mL).
Clinical data (Silness and Löe plaque index, Löe and Silness gingival index, and DMF index) were collected at baseline.
Statistical analysis was performed using Jamovi software. The comparison of CFU counts between groups aimed to determine whether charcoal impregnation reduces microbial contamination of toothbrush bristles.
This study involves minimal risk and no investigational drug or device. Ethical approval was obtained from the Ethics Committee of the Faculty of Dental Medicine of Rabat.
详细描述
- Background and Rationale
Toothbrushes are essential oral hygiene tools, but they can act as reservoirs for microorganisms due to their humid storage environment. This bacterial colonization may reintroduce pathogens into the oral cavity, increasing the risk of oral and systemic infections. Activated charcoal, known for its adsorption capacity and antibacterial potential, has been incorporated into dental products, including toothbrush bristles. However, evidence regarding its effect on bacterial contamination of toothbrushes remains limited.
This trial aims to evaluate whether charcoal-infused bristles reduce microbial contamination compared to standard nylon bristles after 21 days of regular use. 2. Study Objectives
Primary Objective:
To assess the reduction of microbial contamination (CFU/mL) on charcoal-infused toothbrushes compared to conventional toothbrushes after 21 days of use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 24 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Students of the Faculty of Dental Medicine of Rabat (4th or 5th year) aged 18-24 years.
- •In good general health with no systemic diseases.
- •Regular users of manual toothbrushes, brushing at least twice daily.
- •Informed about the study and have signed informed consent.
- •Willing to use the assigned toothbrush and follow study instructions for brushing technique, toothpaste use, and storage of the toothbrush.
排除标准
- •Irregular frequency of tooth brushing.
- •Unwillingness to use a charcoal-impregnated toothbrush or known allergy to activated charcoal.
- •Use of antiseptic mouthwash and/or antiseptic toothpaste.
- •Presence of systemic disease.
- •Current or recent antibiotic therapy (within the 4 weeks prior to the study).
- •High plaque index (>2, Silness & Löe).
- •Periodontitis.
- •Severe gingivitis (gingival index >2, Löe & Silness).
- •Wearing orthodontic appliances.
- •Current oro-pharyngeal infections.
结局指标
主要结局
Reduction of microbial contamination on toothbrush bristles
时间窗: 21 days
The primary outcome is the number of colony-forming units (CFU/mL) measured on toothbrush bristles after 21 days of use. A quarter of the bristles from each brush is cut and placed in sterile saline, vortexed to create a suspension, and 200 µL is inoculated on blood agar plates. Plates are incubated at 37°C for 48 hours, and CFU are counted manually. This outcome assesses the effectiveness of charcoal-impregnated bristles in reducing microbial contamination compared to conventional toothbrushes.
次要结局
未报告次要终点
研究者
Asmae Digoug
Specialist in Conservative Dentistry, Faculty of Dental Medicine Rabat
Mohammed V University in Rabat