Evaluation of the efficacy of Activated Charcoal Pro plus toothpaste in improving teeth whitening and overall oral hygiene improvement.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1.Changes in teeth whitening assessed by VITA Shade Scale at screening, week 4, and week 8.
研究概览
简要总结
This clinical study is designed to rigorously evaluate the efficacy of Activated Charcoal Pro+ toothpaste in improving tooth color and reducing plaque accumulation over an 8-week period. Despite the growing popularity of charcoal-based dentifrices, there is limited clinical evidence supporting their benefits beyond cosmetic effects. This study aims to address this gap by using validated indices such as the VITA Shade Scale for tooth color assessment, along with the Plaque Index and Macpherson’s Modified Stain Index, to quantify changes in oral hygiene status. The Organoleptic Scoring Scale will further evaluate breath quality, providing a holistic assessment of oral health. Continuous safety monitoring, including adverse event reporting and assessments of compliance and tolerability, will ensure a comprehensive safety profile. The findings will contribute valuable evidence regarding the clinical utility, safety, and potential role of activated charcoal-based toothpaste in daily oral hygiene practices, supporting evidence-based recommendations for both consumers and dental professionals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 25.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy males and females aged 25 to 45 years (both included); 2.Individuals with generally healthy oral tissues, without inflammation, redness, or pain, as confirmed by a comprehensive dental examination.
- •This includes no current or recent (within the last 6 months) periodontal treatment or significant oral diseases; 3.Participants with perceived teeth discoloration and need to improve teeth whiteness and overall oral hygiene; 4.Participants with mild and moderate plaque with plaque index 2-4; 5.Participants who have all incisors and canines in the upper and lower jaw; 6.Individuals in good general health without any systemic conditions or medications that could affect oral health or interfere with the study treatments; Participants who provide written informed consent to participate in the study and comply with all study procedures and requirements.
排除标准
- •1.Participants with A1, B1 and C1 shade on Vita Shade scale 2.Individuals with current alcohol or tobacco use 3.Known sensitivity or history of significant adverse effects to any of the investigational products 4.Significant unstable or uncontrolled medical condition which may interfere with a participant participation in the study 5.Participated in tooth stain removal trials in the least 3 months; 6.Individuals who are unable to adhere to the study protocol or have conditions that may interfere with compliance, including cognitive impairments or language barriers; 7.Participants using antibiotics or other medications that could affect oral health or interfere with the study results; 8.Participants involved in concurrent studies with similar assessments or interventions; 9.Participants experiencing severe dry mouth (xerostomia); 10.Participants with chronic bad breath (halitosis) due to treatment or any medical condition; 11.Participants with any known hypersensitivity of charcoal containing oral care products.
结局指标
主要结局
1.Changes in teeth whitening assessed by VITA Shade Scale at screening, week 4, and week 8.
时间窗: Screening, week 4, and week 8.
2.Changes in Investigational Product on Plaque Index (PI) at screening, week 4, and week 8.
时间窗: Screening, week 4, and week 8.
次要结局
- 1.Changes in Macpherson’s Modified Stain Index at baseline, week 4 and week 8.(2.Changes in Organoleptic Scoring Scale (OSS) at baseline, week 4, and week 8.)