ISRCTN52296479已完成未知
Assessment of dentine tubule occlusion in a modified in situ model
GlaxoSmithKline Consumer Healthcare (GSKCH) (UK)0 个研究点目标入组 28 人开始时间: 2016年7月29日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 28
研究概览
简要总结
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29981778 [added 15/02/2019]
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
- •2. Aged between 18 and 80 years
- •3. Understands and is willing, able and likely to comply with all study procedures and restrictions
- •4. Good general and mental health with, in the opinion of the investigator or medically qualified designee:
- •4.1. No clinically significant and relevant abnormalities in medical history or upon oral examination
- •4.2. Absence of any condition that would impact on the subject’s safety or wellbeing or affect the individual’s ability to understand and follow procedures and requirements
- •5. Able to accommodate the lower bi-lateral buccal intra-oral appliances each fitted with four dentine samples
排除标准
- •1. Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
- •2. Women who are breastfeeding
- •3. Current or recurrent disease/dental pathology that in the opinion of the investigator could affect the study outcomes
- •4. Current susceptibility to acid regurgitation
- •5. Any orthodontic appliances, restorations, bridgework or dentures that in the opinion of the investigator would interfere with the study outcomes
- •6. Recurrent or regular aphthous ulcers
- •7. Severe gingivitis, carious lesions and periodontal disease
- •8. Signs of severe dental erosion
- •9. Any condition or medication which in the opinion of the investigator is currently causing xerostomia
- •10. Individuals who require antibiotic prophylaxis for dental procedures
- •11. Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
- •12. Participation in another study (clinical or cosmetic studies) or receipt of an investigational drug within 15 days of the screening visit
- •13. Previous participation in this study
- •14. Recent history (within the last year) of alcohol or other substance abuse
- •15. An employee of the sponsor or the study site or members of their immediate family. The site for this protocol is the Clinical Trials Unit in the Bristol Dental School and Hospital. Employees of the Bristol Dental School and Hospital not associated with the Clinical Trials Unit are eligible to participate
- •16. Any subject who, in the judgement of the investigator, should not participate in the study
研究者
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