A Randomized, Comparative Study to Evaluate the Efficacy and Tolerance of the Medical Device Elgydium Clinic Sensileave Gel (V063B - DP3003) on Dentin Hypersensitivity During Teeth Whitening.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Evaluate the soothing effect of the medical device Elgydium Clinic Sensileave Gel (V063B - DP3003) on dentin hypersensitivity due to teeth whitening
研究概览
简要总结
A dental gel intended to relieve pain related to dentin hyper sensitivity is commercialized in several countries worlwide since May 2017. Its efficacy and tolerance has already been proven in dentin hyper sensitivity. In this new study, we assess the efficacy and tolerance of this tested product in a specific external agression, the teeth whitening.
详细描述
Comparative open-label PMCF (Post-Market Clinical Follow-up) randomized controlled study will be conducted as multicentric trial in adult with dentin hypersensitivity during their teeth whitening. To evaluate the efficacy and tolerance of the medical device Elgydium Clinic Sensileave Gel (V063B - DP3003) on dentin hypersensitivity during teeth whitening
4 visits are planned:
- Visit 1 (V1) - Selection
- Visit 2 (V2) - Start of teeth whitening
- Visit 3 (V3) - Start of tested product application - Inclusion / Randomization
- Visit 4 (V4) - Study end
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- 是
入选标准
- •Subject who has a pain score (i.e. maximum intensity felt while the whitening tray wear) of at least 3 on a NRS ranging from 0 (None) to 10 (Severe) evaluated since the beginning of his teeth whitening.
- •Subject wishing to have a teeth whitening
- •Subject with a healthy gum status according to the investigator
- •Subject with at least 20 natural teeth
排除标准
- •Related to the teeth condition:
- •Subject with active teeth decay
- •Subject with teeth showing evidence of facets of attrition, premature contact, cracked enamel on the teeth to be studied and adjacent teeth
- •Subject with teeth showing evidence of irreversible pulpitis and active periodontal disease
- •Subject having a cutaneous-mucosal disease liable to interfere with study data according to the investigator
- •Subject with an odontological condition, an acute chronic or progressive disease or history of disease considered by the investigator hazardous for the subject or incompatible with the study
- •Related to the treatment/product:
- •Subject having undergone professional desensitizing therapy in the mouth
- •Systemic treatment/product and topical treatment/product in the mouth liable to interfere with study data according to the investigator assessment
结局指标
主要结局
Evaluate the soothing effect of the medical device Elgydium Clinic Sensileave Gel (V063B - DP3003) on dentin hypersensitivity due to teeth whitening
时间窗: About 10 days
NRS ranging from 0 (None) to 10 (Severe)
次要结局
- Evaluate the effect of the medical device Elgydium Clinic Sensileave Gel (V063B - DP3003) on teeth whitening(About 10 days)
- Evaluate the soothing effect of the medical device Elgydium Clinic Sensileave Gel (V063B - DP3003) on dentin hypersensitivity due to teeth whitening(About 10 days)