ISRCTN99464691已完成Unknown
A clinical study to evaluate the plaque removal performance of a new power toothbrush and and impact on the behavioral changes of its users
Procter & Gamble (United States)0 个研究点目标入组 41 人开始时间: 2023年4月24日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 41
研究概览
简要总结
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37816615/ (added 08/02/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •In order to be included in the study, each subject must:
- •1. Be at least 18 years of age
- •2. Provide written informed consent prior to participation and receive a signed copy
- •3. Usually use an Oral-B power toothbrush handle (O/R)
- •4. Be in good general health as determined by the investigator/designee based on a review/update of their medical history
- •5. Possess a minimum of 16 scorable teeth with facial and lingual scorable surfaces
- •6. 2nd molars upper and lower from both sides must be present and have at least four upper and lower front teeth
- •7. The distribution of the teeth needs to be balanced between the quadrants to guarantee a good positioning during imprint taking and repositioning of the final imprint
- •8. Have a screening whole mouth mean TQHPI score of =1.75
- •9. Refrain from all oral hygiene procedures for approximately 24 hours prior to this visit and agree to follow this same restriction prior to all visits
- •10. Refrain from eating, drinking*, chewing gum and any tobacco use for at least 2 hours prior to this visit and agree to follow these same restrictions prior to all visits *Allowed small sips of water up until 45 min prior to their appointment
- •11. Agree not to participate in any other oral care study for the duration of this study
- •12. Agree to delay any elective dentistry, including dental prophylaxis, until study completion and to report any non-study dentistry received during the course of this study
- •13. Agree to refrain from using any non-study toothbrushes, dentifrices, mouth rinses, tooth whitening products or floss for the study duration other than their usual at-home toothbrush and toothpaste between Screening and Visit 1 and between Visit 1 and Visit 2
- •14. Agree to refrain from using any non-study toothbrushes, dentifrices, mouth rinses, tooth whitening products or floss for the study duration other than their distributed toothbrush and toothpaste between Visit 2 and 3
- •15. Agree to return for their scheduled visits and to follow all study procedures
排除标准
- •Subjects are excluded from study participation where there is evidence of:
- •- Any carious lesions requiring restorative treatment;
- •- Active treatment for periodontitis;
- •- Fixed orthodontic appliances on the facial surface of their anterior teeth, or have removable denture prosthesis;
- •- Any disease or conditions that could be expected to interfere with examination procedures or with the subject safely completing the study (including allergies to dyes);
- •- Using any antibiotics or a chlorhexidine mouth rinse any time within the 2 weeks prior to this visit.
研究者
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