A Pilot Clinical Investigation of the Performance of Epinamel for Dental White Spot Lesions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Regression or progression of white spot lesions (WSLs), determined by changes in lesion size measured (micrometers) by morphometry.
研究概览
简要总结
Mintech-Bio Ltd is a UK-based start-up company which was created to turn 14 years of research from our co-founder Dr Alvaro Mata at Queen Mary University into a real-world product.
Loss of tooth enamel from issues such as decay or erosion is a great cause of dental problems, affecting over half of people around the world. There is also evidence to suggest that having poor oral health may be connected to other health issues such as diabetes, heart problems, and lung infections like pneumonia.
While treatments like fluoride varnishes and remineralization solutions can help with the effects of enamel loss, there's currently no easy-to-use option that actually regrows enamel in a way that closely matches the natural look and strength of real enamel.
Mintech-Bio has created a special gel that helps rebuild tooth enamel back to its natural strength and structure. This new invention could take the place of fluoride treatments and make a big difference in preventing tooth problems around the world. The purpose of this research study is to demonstrate the efficacy of the Epinamel device in the treatment of dental white-spot lesions.
If you meet all the screening criteria you will be entered into the study and shall have the device applied after the removal of dental braces. Each trial participant will have the treatment product applied to a tooth on one side of the mouth, and a comparative 'control' product named Curodont Repair (vVardis Professional, Switzerland will be applied on the opposite side of the mouth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Will have dental braces or brackets removed immediately prior to or up to 48 hours prior to potential study participation
- •Have at least one active non-cavitated carious lesions around the bracket area with a rough, chalky and matte surface (white spot lesions - WSLs) at each side of the mouth;
- •Have carious lesion which are fully visible, assessable and accessible;
- •Are able and willing to observe good oral hygiene throughout the study;
- •Have ≥20 teeth and a BPE score of <3;
- •Have completed fixed orthodontic treatment within the past 24-120 hours.
- •Are aged 12-60 years
- •Are willing and able to attend the on-study visits;
- •Are willing and able to understand all study-related procedures;
- •Provide written informed consent (by parent/guardian if minor) before participation in the study.
- •No systemic diseases or concomitant medication affects salivary flow in order not to negatively affect the remineralising process.
排除标准
- •• Patients with known hypersensitivity to glutaraldehyde or any of the product's ingredients.
- •Patients with severe pulpitis or oral infections
- •Patients who are still be undergoing treatment using dental braces or brackets at time of study initiation
- •Patients who are vulnerable
- •Patients who are participating in another trial
- •Patients with tetracycline pigmentation, dental fluorosis, or enamel hypoplasia
- •Participants who had evidence of reduced salivary flow, systemic, or medical complications
- •Participants with cavitated lesions
研究组 & 干预措施
Treatment group
Epinamel one side of mouth Curadont opposite side of mouth
干预措施: Varnish (Device)
结局指标
主要结局
Regression or progression of white spot lesions (WSLs), determined by changes in lesion size measured (micrometers) by morphometry.
时间窗: 6 weeks
Classified as the proportion of lesions that: Regress (decrease in size by \>20% at 6 weeks with respect to baseline), Progress (increase in size by \>20% at 6 weeks with respect to baseline), or Remain approximately stable in size (decrease or increase in size by ≤20% at 6 weeks with respect to baseline). Assessment method: Morphometric measurement (micrometers) of standardized, calibrated clinical photographs.
次要结局
- Laser Fluorescence Readings (DIAGNOdent Pen, KaVo, Biberach, Germany) Objective fluorescence-based assessment of lesion status.(6 weeks)