NCT02676219已完成不适用
Pilot Study to Investigate the Reparative Effect of a Two Phase Oral Care Product Containing SMFP and NaF on Enamel Against a Dietary Acid Exposure Utilising an Impression Technique to Capture in Vivo Images of Teeth
Unilever R&D2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2015年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- changes in enamel surface topography using an impression methodology with scanning electron microscopy
研究概览
简要总结
The study design is a randomised, split mouth, blind with respect to study analysts (microscopist, image grader) two treatment clinical study in 10 healthy participants with sound tooth enamel. The study will comprise of a screening visit, pre-baseline visit and 5 subsequent clinic visits. At the screening visit, participants will give consent to participate in the study. Medical history and concomitant medications will be recorded. Eligibility will be determined following an oral soft tissue (OST) examination and an evaluation of dentition exclusions. Two suitable anterior teeth will be identified for study assessments, these teeth must be at least one tooth apart in the mouth. Saliva samples will be collected from the participants at set points during the study to look at any changes in salivary pH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Consent: Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- •Age: Aged at least 18 years.
- •Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions.
- •General Health: Good general health with (in the opinion of the investigator or medically qualified designee) no clinically significant and relevant abnormalities of medical history or physical examination.
- •Study teeth must show no signs of exposed dentine at the cervical margin.
- •In the opinion of the investigator the study teeth must have a healthy gingiva as determined during the OST examination.
排除标准
- •Pregnancy Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
- •Breast-feeding Women who are breast-feeding.
- •Current or recurrent disease/dental pathology that could affect the assessments.
- •In the judgement of the investigator or medically qualified designee, any condition or medication which is causing cause Xerostomia.
- •Diabetes Mellitus.
- •Susceptibility to acid regurgitation.
- •Be susceptible to high dental erosion after drinking acidic soft drinks or juices
- •General Dental Exclusions
- •Any orthodontic appliances, restorations, bridgework or dentures that would interfere with the study evaluations or scheduled for such treatment within the timescale of the study.
- •Recurrent or regular aphthous ulcers.
- •Severe gingivitis, carious lesions treated and untreated periodontal disease.
- •Excessive signs of dental erosion or a previous history of being susceptible to high dental erosion after drinking acidic drinks
- •Tooth bleaching within past 2 months.
- •Suffer from dentine hypersensitivity.
- •Allergy/Intolerance Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- •Clinical Study/Experimental Medication
- •Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
- •Previous randomisation into this study.
- •Substance abuse Recent history (within the last year) of alcohol or other substance abuse.
- •Personnel An employee of the sponsor, member of the study site or a staff family relative. 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.
- •Any participant who, in the judgement of the investigator, should not participate in the study.
研究组 & 干预措施
RS01
Experimental
oral care product containing containing sodium monofluorophosphate and sodium fluoride
干预措施: RS01 (Other)
Water
Placebo Comparator
Water
干预措施: Water (Other)
结局指标
主要结局
changes in enamel surface topography using an impression methodology with scanning electron microscopy
时间窗: 6 hours
次要结局
- changes in enamel surface topography using an impression methodology with scanning electron microscopy(2 hours)
研究者
研究点 (2)
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