ISRCTN10112852已完成未知
A comparative assessment of plaque removal and toothbrush compliance between a manual and an interactive electric toothbrush among adolescents: a single-center, single blind randomized controlled trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30075780
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Provided written informed consent (including her/his guardians) and given a signed copy of the Informed Consent form
- •2. Aged 13-17 years
- •3. Typically uses a manual toothbrush
- •4. In good general health as determined by the investigator/designee based on a review of their medical history
- •5. Minimum of 16 natural teeth (excluding third molars) with facial and lingual scorable surfaces
- •6. At least one, but not more than four, 'Focus Care' areas (per investigator discretion)
- •7. Whole mouth average screening Turesky et al Modification of the Quigley Hein (TQHPI) score of =1.75
- •8. Agrees not to participate in any other oral care study for the duration of this study
- •9. Agrees to delay any elective dentistry, including dental prophylaxis, until study completion and to report any non-study dentistry performed on them at any time during the course of this study
- •10. Agrees to maintain their same regular at-home toothbrush and toothpaste between Screening and the Baseline visit
- •11. Agrees to refrain from using any non-study oral hygiene products for the duration of the study, except using their regular at-home toothbrush and toothpaste between the Screening and the Baseline visit
- •12. Agrees to return for their scheduled visits and follow all study procedures
- •13. Agrees to refrain from brushing their teeth and from performing any other oral hygiene procedures after their morning brushing (which is to be no later than 8 am) prior to the Screening visit and agree to follow these same restrictions prior to all visits
- •14. Agrees to refrain from eating, chewing gum, and drinking (except small sips of water up until 45 minutes prior to their appointment) for at least 2 hours prior to the Screening visit and agree to follow these same restrictions prior to all visits
- •15. Familiar with Android smartphone
排除标准
- •1. Several caries, open or untreated caries, severe gingivitis or advanced periodontitis requiring prompt treatment
- •2. Active treatment for periodontitis
- •3. Smoking or any other type of tobacco use
- •4. Use of antibiotics or a chlorhexidine mouth rinse any time within the 2 weeks prior to the Screening visit
- •5. Fixed orthodontic appliances or removable partial dentures
- •6. Receiving a dental prophylaxis any time within the 4 weeks prior of the Screening visit
- •7. (Peri)oral piercings
- •8. Any disease or condition that could be expected to interfere with examination procedures or with the subject’s safe completion of this study
研究者
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