ACTRN12620000747921进行中（未招募）未知
Evaluation of Efficacy of Experimental Dentrifice Formulations with Different Forms of Fluoride and/or Other Agents to Remineralize Enamel and Dentine Subsurface Lesions in Healthy Adults: a Double-Blind Randomized In Situ Clinical Trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •Aged 18-75 years of age;
- •Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
- •Be in good general health based on medical/dental history and oral exam;
- •Agree not to participate in any other oral study for the study duration;
- •Have a reasonable functional dentition as determined by the oral examiner and sufficient teeth to support the fabricated dental appliance;
- •Be willing to participate in the study, able to follow the study directions, successfully tolerate/perform all study procedures, and willing to return for all specified visits at their appointed time;
- •Be willing to refrain from using non-study dentifrice, mouth rinse, chewing gum, and other non-study oral care products during the study;
- •Be willing to postpone all elective dental procedures until the study has been completed;
- •Be willing to refrain from chewing gums while using the test products;
- •Be willing and able to refrain from wearing a nightguard (occlusal splint) for the entire course of the study (for nightguard wearers only).
- •In addition, to be eligible to participate in this study, an individual will need to meet all the following criteria:
- •Ability to understand, and ability to read and sign, the informed consent form;
- •Have at least 22 natural teeth;
- •Have a gum-stimulated whole salivary flow rate at least 1.0 mL/minute and unstimulated whole salivary flow rate at least 0.2 mL/minute.
- •Willingness to comply with all study procedures and be available for the duration of the study.
- •Only staff and students of the Melbourne Dental School, University of Melbourne will be eligible to participate.
排除标准
- •Advanced periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;
- •Active treatment for periodontitis;
- •Medical condition which requires premedication prior to dental visits/procedures;
- •Untreated dental caries (e.g. cavities);
- •Self-reported pregnancy or plans to become pregnant during the study;
- •Existing dental work which prevents wearing of the appliance including orthodontic appliances or removable dentures;
- •Chronic disease such as diabetes or use of medications that cause gum swelling;
- •Any diseases or conditions (including sensitivity to dentifrice ingredients) that might interfere with examination procedures or the participant safely completing the study;
- •Treatment with antibiotics or anti-inflammatory medicines in the month prior to starting the study;
- •Use of drugs that may interact with the dentrifice slurries or which may affect salivary flow rate;
- •History of health conditions requiring antibiotic coverage prior to dental treatment;
- •Serious infectious disease;
- •Any other medical or dental conditions deemed to put the health and well being of the participant or research team at risk if the potential participant participated in the study.
研究者
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