NCT07819370尚未招募4 期
Early Enamel Lesion Detection and Management With a New Diagnostic Tool
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Enamel Lesions per BlueCheck
研究概览
简要总结
The primary objective of this 12-week study is to test BlueCheck's ability to identify enamel lesions consistently, and its ability to track changes in these lesions over time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent/Assent Form.
- •Male and female subjects aged 13 years or older.
- •Availability for the duration of the study.
- •Good general health and good oral health based on the opinion of the study investigator.
- •Subjects must have active enamel lesions and no cavities requiring immediate restoration in the mouth.
- •Subjects must be candidates for high fluoride toothpaste treatment.
排除标准
- •Subjects with fixed or removable orthodontic appliances or removable partial dentures.
- •Obvious signs of periodontal disease or any condition that the dental examiner considers exclusionary from the study.
- •Cavities.
- •Concurrent participation in another oral clinical study.
- •Self-reported pregnant and/or lactating women, or those planning to become pregnant during the study.
- •History of allergies or sensitivity to personal care consumer products or their ingredients.
- •Medical condition which requires premedication prior to dental visits/procedure.
- •Significant oral soft tissue pathology, excluding plaque-induced gingivitis.
- •Dental prophylaxis within 30 days prior to study start.
- •Subjects who must receive dental treatment during the study dates.
- •Immunocompromised individuals (HIV, AIDS, immunosuppressive drug therapy).
- •Use of smokeless tobacco, vaping, or e-cigarettes or suspected substance abuse.
- •Current smokers (if former smoker, should have stopped at least 1 month prior to Visit 1).
- •Subjects who have an infectious disease and/or other blood borne diseases (Hepatitis series, HIV, tuberculosis).
研究组 & 干预措施
Test Group
Experimental
This is a monadic study with one arm. All subjects will receive the intervention.
干预措施: BlueCheck (Device)
Test Group
Experimental
This is a monadic study with one arm. All subjects will receive the intervention.
干预措施: Prevident 5000ppm Booster Plus Toothpaste (Drug)
结局指标
主要结局
Enamel Lesions per BlueCheck
时间窗: Baseline, 4 weeks, and 12 weeks
Number of enamel lesions counted after using BlueCheck
次要结局
- Self-perceived reactions to BlueCheck application(Baseline, 4 weeks, and 12 weeks)
- Enamel Lesions per Xray(Baseline, 4 weeks, and 12 weeks)
- Enamel lesions per intraoral camera(Baseline, 4 weeks, and 12 weeks)
- White spots(Baseline, 4 weeks, and 12 weeks)
研究者
研究点 (1)
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