ISRCTN84038664进行中(未招募)未知
A clinical evaluation of plaque detection by a newly developed QLF (Quantified Light-Induced Fluorescence) based technology
Procter & Gamble (United States)0 个研究点目标入组 50 人开始时间: 2022年7月5日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •1. Give written informed consent (if underage including her/his guardians) and given a signed copy of the Informed Consent form;
- •2. Be at least 13 years of age;
- •3. Have no fixed orthodontic appliance or attachments on both arches, Retainer in both arches are allowed;
- •4. Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
- •5. Have plaque and at least one more of the following: demineralization/white spot lesions, remineralized caries at the fissures and accessory cusps, caries, tartar, fluorosis;
- •6. Possess a minimum of 24 natural and crowned/bridges evaluable teeth including 8 frontal teeth;
- •7. Be in good general health as determined by the Investigator/designee based on a review of the medical history/update for participation in the study;
- •8. Agree not to participate in any other clinical study for the duration of this study;
- •9. Agree to delay any elective dentistry, including dental prophylaxis, until study completion;
- •10. Agree to return for the scheduled clinical visit and follow study procedures.
排除标准
- •1. Severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;
- •2. Active treatment for periodontitis;
- •3. Use of antibiotics two weeks prior to study initiation;
- •4. Any diseases or conditions that could be expected to interfere with the subject safely completing the study.
- •5. Presence of cardiac pacemaker;
- •6. Dental prophylaxis within 2 weeks prior to the screening visit.
- •7. Fixed orthodontic appliance e.g. Multibrackets apparatus or attachments on at least one arch
研究者
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