ISRCTN49336428已完成未知
The effect of dental varnishes with casein phosphopeptide–amorphous calcium phosphate (CPP-ACP) for the management of root caries in patients with xerostomia: a 12-month randomised clinical trial
Queen Mary University of London (UK)0 个研究点目标入组 80 人开始时间: 2016年2月10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
- 80
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. Participant is willing and able to give informed consent for participation in the trial
- •2. Male or female = 18 years of age
- •3. Minimum one primary root caries (PRC), which is accessible for the diagnostic procedure
- •4. Participants who agree to return for assessments during the study period
- •5. Participants who are capable of giving informed constant
- •6. Saliva sample test showing a quantitative change in unstimulated whole saliva; =0.16 mL/min
- •7. Ability to carry out oral hygiene practice instruction
- •8. Participants who agree to use the standard dentifrice (Aquafresh, GSK, 1450 ppm fluoride) with a medium sized toothbrush (Oral-B) that will be provided by the research team
- •9. Participants are not involved another other clinical study investigating the oral care products
- •10. Participants not using any other mouthwash/dentifrice/gels/chewing gums/lozenges containing test ingredients and fluoride
- •11. In the Investigator’s opinion, is able and willing to comply with all trial requirements
- •12. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial
- •13. Medically allowable to undergo the baseline and follow-up assessments
排除标准
- •1. No active primary root carious lesions
- •2. Presence of chronic/aggressive periodontal disease concerning the test tooth in the study tooth (purulent exudates, tooth mobility, and/or extensive bone loss)
- •3. Participation in another dental study testing different dental products during the previous three months and during the study period
- •4. Any condition, which in the opinion of the investigator, would preclude participation by the subject (such as cross-infection control risk)
- •5. Cognitive defect due to mental illness, depression, Alzheimer's disease, or dementia
- •6. Secondary root carious lesion
- •7. Hypersensitivity to either milk or one of the test products
- •8. Test tooth with untreated cavitated proximal or occlusal caries
- •9. Patient using any other topical agent that may affect the results such as mouthwash, chewing gum and lozenge with active ingredients or antibacterial agents
- •10. Female participant who is pregnant, lactating or planning pregnancy during the course of the trial
- •11. Significant renal or hepatic impairment
- •12. Scheduled elective surgery or other procedures requiring general anaesthesia during the trial
- •13. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial
- •14. Participants who are prescribed for long-term systematic antibiotics
研究者
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