NCT07068204招募中不适用
Caries-preventing Effect of 2% Calcium Hypophosphite Toothpaste Compared to a Sodium Fluoride Toothpaste (1450ppm F) in Adults
Dr. Joachim Enax2 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2026年1月22日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 164
- 试验地点
- 2
- 主要终点
- Evaluate the efficacy of the 2% Calcium Hypophosphite Toothpaste compared to Sodium Fluoride Toothpaste (1450 ppm F) regarding the Decay-Missing-Filled index
研究概览
简要总结
The aim of the study is to compare the caries-preventive effect of the test and control toothpaste in order to proof the non-inferiority of the test toothpaste compared to the control.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A minimum of 10 healthy molars and premolars (DMFS of these teeth = 0)
- •Willingness to use an electric (powered) toothbrush
- •Willingness to use interdental floss
- •Willingness to have bitewing radiographs taken
- •Willingness to undergo an oral examination by an intraoral camera (DIAGNOcam)
排除标准
- •Untreated caries [clinical investigation and analysis with an intraoral camera (DIAGNOcam)] (→ unsuitable subjects with one or two untreated caries in need of a restoration can become eligible after restorative therapy. If there are three or more untreated caries patients will be excluded)
- •Xerostomia (medication, radiation, disease induced)
- •Chemo/radiation therapy
- •Physical or mental disability which prevents proper oral health care
- •Orthodontic treatment
- •Severe periodontitis at the Baseline Visit (pocket depth on at least one tooth ≥ 5.5 mm)
- •Known hypersensitivity to one of the ingredients of the toothpastes to be tested
- •Regular medication intake interfering with salivary function or flow
- •Current pregnancy, the wish to become pregnant, the suspicion of being pregnant, or breastfeeding or in the course of the study
- •3 or more carious lesions/restorations in last 36 months until Baseline Visit
- •Teeth missing due to caries in last 36 months until Baseline Visit
研究组 & 干预措施
2% Calcium Hypophosphite Toothpaste
Experimental
干预措施: 2% Calcium Hypophosphite Toothpaste (Device)
Sodium Fluoride Toothpaste (1450 ppm F)
Placebo Comparator
干预措施: Sodium Fluoride Toothpaste (1450 ppm F) (Device)
结局指标
主要结局
Evaluate the efficacy of the 2% Calcium Hypophosphite Toothpaste compared to Sodium Fluoride Toothpaste (1450 ppm F) regarding the Decay-Missing-Filled index
时间窗: Day 1, Day 182±28, Day 365±28 vs. Day 546±28
Comparison between the 2% Calcium Hypophosphite Toothpaste and Sodium Fluoride Toothpaste (1450 ppm F): Proportion of subjects showing no increase in overall Decay-Missing-Filled index during the observation period of 546 days (assessed by the investigator).
次要结局
- Evaluate the efficacy of the 2% Calcium Hypophosphite Toothpaste compared to Sodium Fluoride Toothpaste (1450 ppm F) in the prevention of interproximal caries lesions(Day 1 vs. Day 546±28)
- Evaluate the efficacy of 2% Calcium Hypophosphite Toothpaste compared to Sodium Fluoride Toothpaste (1450 ppm F) in the prevention of dental plaque deposition using the Plaque Control Record (PCR) index(Day 1, Day 182±28, Day 365±28 vs. Day 546±28)
研究者
Dr. Joachim Enax
Senior Scientist Oral Care
Dr. Kurt Wolff GmbH & Co. KG
研究点 (2)
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