ISRCTN28649560进行中（未招募）未知
Clinical study to compare the plaque removal efficacy of a new power toothbrush with a reference manual brush by means of digital plaque imaging analysis
Procter & Gamble (United States)0 个研究点目标入组 46 人开始时间: 2020年8月21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
- 46
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Be at least 18 years of age
- •2. Provide written informed consent prior to participation and be given a signed copy of the informed consent form
- •3. Be in general good health as determined by the Investigator/designee based on a review/update of their medical history
- •4. Have sufficient amount of plaque (estimated 10% coverage on buccal sites of front teeth after 24 hours build-up as estimated by DPIA operator)
- •5. Possess a minimum of 10 natural anterior teeth with facial scorable surfaces (Not including teeth with crowns, excessive facial restorations or severe staining from tetracycline, fluorosis or hypocalcification)
- •6. Agree not to participate in any other oral care study for the duration of this study
- •7. Agree to return for scheduled visits and follow the study procedures
- •8. Agree to refrain from use of any non-study oral hygiene products (including prescription rinses) for the duration of the study
- •9. Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study and to report any non-study dentistry received during the course of this study
- •10. Agree to refrain from using dental floss during the treatment periods of this study (Tuesday through Tuesday)
- •11. Agree to refrain from all oral hygiene procedures for approximately 24 hours prior to all subsequent morning visits
- •12. Agree to refrain from all oral hygiene procedures between all subsequent morning on-site brushings and the afternoon imaging visits
- •13. Agree to refrain from eating, drinking*, chewing gum and using tobacco for 2 hours prior to their morning appointments and 1 hour prior to their afternoon appointments? *The only exception being allowed small sips of water up until 1 hour prior to their morning appointments
排除标准
- •1. Hypersensitivity to dyes
- •2. Any caries lesions requiring restorative treatment
- •3. Active treatment for periodontitis
- •4. Fixed facial or lingual orthodontic appliances
- •5. Self-reported pregnancy or lactation
- •6. Performing any oral hygiene the morning of or the evening prior to their Visit 1 study visit
- •7. Having eaten, drank, used tobacco or chewed gum for at least 2 hours prior to their Baseline visit (Small sips of water will be allowed up to 45 minutes prior to the visit)
- •8. Any diseases or condition that could be expected to interfere with examination procedures or with the subject safely competing the study (including allergies to dyes)
- •9. Inability to undergo study procedures
- •10. Using an antibiotic or a chlorhexidine mouth rinse any time within 2 weeks prior to this visit
- •11. Calculus on the facial surface of their teeth (per operator discretion)
研究者
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