Caries-preventing Effect of a Hydroxyapatite-toothpaste in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 试验地点
- 2
- 主要终点
- Proportion of subjects showing no increase in overall DMFS-index
研究概览
简要总结
Target question is as the following one:
Does the daily use of a fluoride-free, microcrystalline hydroxyap-atite (HAP) - containing test toothpaste have a non-inferior caries preventing effect in the permanent dentition compared to the regular use of a fluoride control toothpaste (1450 ppm F-) with proven caries preventive efficacy (Walsh et al. 2019)? This multicenter, non-inferiority clinical trial, randomized, double-blind, active-controlled design, two-armed study evaluates the hypothesis that the home regular use of a toothpaste containing microcrystalline hydroxylapatite (HAP) (test toothpaste) provides a caries preventive effect in adults aged 18-45 comparable to the caries preventive effect provided by the regular use of a fluoridated tooth paste (1450 ppm -F) (control toothpaste) over observation periods of max. 18 months. Caries development will be assessed according to the clinical criteria of the Decay Missing Filling Surface Index (DMFS).
详细描述
Caries-preventing effects of hydroxyapatite toothpastes have been shown in vivo [children and adolescents] (Schlagenhauf et al. 2019, Paszynska et al. 2021), in situ (Amaechi et al. 2019), and in vitro (Tschoppe et al. 2011). However, to date, the caries-preventing effect of a hydroxyapatite toothpaste in adults (without orthodontic treatment) has not been investigated in a clinical trial compared to fluoride toothpastes.
The aim of this clinical trial is to assess in cohorts of adults whether 2 x daily tooth brushing at home over an observation period of 18 months with a fluoride-free, microcrystalline hydroxyapatite (HAP) - containing test toothpaste has a non-inferior caries preventing effect in the permanent dentition compared to the regular use of a fluoride control toothpaste (1450 ppm F-) with proven caries preventive efficacy (Walsh et al. 2019). The study is designed as a multicentre, two armed, non-inferiority trial and will be performed by 2 study centres in Poland. Caries development will be assessed by the Decay Missing Filling Surface Index (DMFS).
There are planned 4 visits for all subjects included to the project. Description of the 4 visits is presented below.
Visit 1 (Screening and Baseline): Study day 0, informed consent, screening, collection of baseline data, and study inclusion Subjects potentially suitable for the study will be informed by the investigator about the nature, sig-nificance, and scope of the clinical trial according to the requirements described in the written subject information.
Before study inclusion, the willingness of the subjects to properly follow the study protocol during the complete treatment period of 546 days must be assessed. Only when subjects have given their written informed consent, he/she will be included as study participant.
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)
盲法说明
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) The study will be double-blinded (blinded for the study subjects as well as for the investigators). The blind must not be broken throughout the study. Only after study end, study subjects will be informed on the toothpaste received, if requested by the subject.
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
- •provision of written informed consent
- •age 18-45 years (both men and women)
- •a minimum of 10 healthy molars and premolars (DMFS of these teeth = 0)
- •willing to use an electric (powered) toothbrush
排除标准
- •Medical Reasons
- •untreated caries [clinical investigation and analysis with DI-AGNOcam] (→ unsuitable subjects with untreated caries in need of a restoration can become eligible after restorative therapy)
- •severe periodontitis at the baseline-visit (pocket depth on at least one tooth ≥ 5.5 mm)
- •orthodontic treatment
- •known hypersensitivity to one of the ingredients of the tooth-pastes to be tested
- •systemic disorders interfering with salivary function or flow
- •regular medication intake interfering with salivary function or flow
- •Other Reasons:
- •Participation in any other clinical study within the past 3 months or ongoing
- •lack of intellectual or physical ability to conduct the study properly
- •Any other reason that, in the opinion of the investigator, dis-qualifies the subject from participating in the study
结局指标
主要结局
Proportion of subjects showing no increase in overall DMFS-index
时间窗: 546 days
Proportion of subjects showing no increase in overall DMFS-index (DMFSVisit 4 - DMFSVisit 1 = 0) during the observation period
次要结局
- roportion of subjects experiencing no change in mineral density(546 days)
- Changes in the coverage of all teeth with bacterial plaque ac-cording to the criteria of the Plaque Control Record(546 days)
研究者
Elzbieta Paszynska
Head of Department of Integrated Dentistry, Principal Investigator, Clinical Associate Professor
Poznan University of Medical Sciences