ISRCTN13889391已完成未知
A clinical study investigating the benefits of a hydroxyapatite/potassium nitrite and aluminium lactate cosmetic toothpaste to help the discomfort associated with dentine hypersensitivity compared to a benchmark marketed toothpaste
niversity of Bristol0 个研究点目标入组 82 人开始时间: 2020年2月26日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 82
研究概览
简要总结
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33647373/ results (added 17/03/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Voluntary written informed consent given
- •2. Aged 18 to 65 years
- •3. Good general and mental health in the opinion of the investigator or medically qualified designee
- •a. No clinically significant and relevant abnormalities of medical history or oral examination
- •b. No condition that would impact on safety, wellbeing or ability to understand and follow study procedures and requirements
- •4. Understands and is willing, able and likely to comply with all study procedures and restrictions
- •5. Minimum of 20 natural teeth
- •6. 2 sensitive teeth as defined by Schiff scores 2/3 to evaporative stimuli
- •7. Minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars), that have signs of sensitivity, measured by qualifying tactile stimulus (Yeaple = 20g) and evaporative air assessment (Schiff sensitivity score = 2)
排除标准
- •1. Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
- •2. Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 15 days of the screening visit
- •3. Previous participation in this study
- •4. Recent history (within the last year) of alcohol or other substance abuse
- •5. An employee of the sponsor or members of their immediate family
- •6. An employee of the site for this protocol (the Bristol Dental School and Hospital) and associated with the Clinical Trials unit
- •6. Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes.
- •7. Any condition which, in the opinion of the investigator, causes xerostomia
- •8. Dental prophylaxis within 4 weeks of screening
- •9. Tongue or lip piercing
- •10. Desensitizing treatment within 2 weeks of screening (professional sensitivity treatments and non-dentifrice sensitivity treatments)
- •11. Active periodontal disease
- •12. Teeth bleaching within 8 weeks of screening
- •13. Teeth with exposed dentine but used as abutments for fixed or removable partial dentures, teeth with full crowns or veneers, orthodontic bands or cracked enamel
- •14. Teeth with evidence of caries
- •15. Daily prescription of medication/treatments which, in the opinion of the investigator, could interfere with the perception of pain. Including but not limited to: analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilizers, anti-depressants, and mood-altering and anti-inflammatory drugs.
- •16. Any subject who, in the judgment of the investigator, should not participate in the study
研究者
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