Effectiveness of Two Different Desensitizing Dental Varnishes: A Prospective, Randomized Split Mouth Clinical Investigation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Change of dentin hypersensitivity
研究概览
简要总结
Dental varnishes are commonly used to relieve dentin hypersensitivity by forming a protective film that occludes dentinal tubules and reduces fluid flow. This clinical investigation aims to compare the desensitizing effect of a fluoride containing varnish with a fluoride free placebo varnish. Primary and secondary objectives include evaluating short and long term reductions in dentinal hypersensitivity, assessing patient reported outcomes and daily experiences, and monitoring the varnish's tolerability and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent signed by the subject
- •Age: 18-65 years
- •Hypersensitivity assessment scale ≥ Grade 2 in
- •two non-neighboring teeth in different quadrants
- •The affected teeth are/have: vital, caries-free, received no restorations within the last month
- •No change in medication anticipated over the next 3 months (e.g. due to upcoming surgery etc.)
排除标准
- •Contraindications and limitations of the MD as described in the instructions for use.
- •Known hypersensitivity or allergy to the device material (especially acrylates, mint flavouring)
- •Pregnant or other vulnerable subjects
- •Participants with severe systemic disease
- •Enrolment of employees of the dental clinic of Ivoclar Vivadent AG
- •Recent change in medication concerning Analgesics, NSAIDs, psychotropic drugs, other medications that may alter pain perception
- •Intake of analgesics prior to appointment
- •Professional desensitizing therapy in the last 3 months
- •Bleaching procedures in the last 4 weeks
- •Confounding dental conditions at test sites: defective or extensive restorations, abutment teeth for prostheses, recent restorations, pulpitis/periapical pathology.
- •Current or recent use of desensitizing toothpastes or mouthrinses (i.e. products specifically marketed for the treatment of dentin hypersensitivity) within 4 weeks prior to enrolment
研究组 & 干预措施
Fluoride-containing varnish
A fluoride-containing varnish is applied to a tooth that is hypersensitive.
干预措施: Fluoride-containing varnish (Device)
Fluoride-free varnish
A fluoride-free varnish is applied to a tooth that is hypersensitive.
干预措施: Fluoride-free varnish (Device)
结局指标
主要结局
Change of dentin hypersensitivity
时间窗: 1 week
assessed by patient response to an air stimulus using a pain scale (grades 0-4, lower scores mean a better outcome)
次要结局
未报告次要终点