NCT02466945Unknown不适用
Oral and Dental Tolerance and Efficacy on Dentinal Hypersensitivity of a Dental Gel, on Adults
Pierre Fabre Dermo Cosmetique2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2015年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Global tolerance according to a 5-point grading scale taking into account physical signs observed and graded by the dentist and functionnal signs observed and graded by the patient
研究概览
简要总结
The aim of this clinical trial is to evaluate the tolerance and efficacy of a dental gel in patients with dentinal hypersensitivity.
详细描述
The aim of this clinical trial is to evaluate the tolerance and efficacy of dental gel V063B-DP3003 in patients with dentinal hypersensitivity, under normal conditions of use, under dentist control.
The primary objective of this study is to evaluate the global oral and dental tolerance of the studied product after 28 days of use.
Some efficacy objectives have been added to observe the efficacy of the dental gel. The dentinal hypersensitivity will be evaluated by the investigator with a thermal stimulus on two sensitive teeth selected by the investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •Aged between18 and 70 years included
- •Having signed his/her written informed consent,
- •If it is a woman of childbearing potential :
- •Must have been using an effective method of contraception Negative Urine pregnancy test at inclusion,
- •Subject who can be reached in case of emergency,
- •Subject willing to be compliant to the protocol,
- •Subject able to fill out the daily log and the questionnaire.
- •Subject with at least 20 natural teeth (especially on the studied teeth),
- •Subject with an healthy gum status according to the investigator,
- •Subject with a mild to moderate dentinal hypersensitivity on at least 2 hypersensitive non adjacent teeth: with a Schiff cold air index from 1 to 2
- •Subjects who show a response typical of sensitivity to the cold air blast at visit 1.
排除标准
- •Subject participating to any other biomedical research projects,
- •For women : Pregnant or breastfeeding,
- •Has forfeited his/her freedom by administrative or legal award or is under guardianship,
- •Subject who, in the judgement of the investigator, is not likely to be compliant during the study,
- •Subject unable to understand the information given (for linguistic or psychiatric reasons) and to give his/her consent in writing,
- •Subject having dental braces
- •Subject having immune system disorder,
- •Subject having asthma,
- •Subject having a disease liable to interfere with study data according to the investigator,
- •Subject with teeth showing evidence of facets of attrition, premature contact, cracked enamel on the tooth to be studied and adjacent teeth,
- •Subject with teeth showing evidence of irreversible pulpitis and active periodontal disease,
- •Subject having caries on the tooth to be studied and adjacent teeth
- •Subject having restauration of any type in the tooth to be studied,
- •Subject having occlusal overload or occlusal adjustment recently made in the tooth to be studied,
- •Subject with crowns , bridges in the area of sensitivity,
- •Subject had undergone professional desensitizing therapy during the 3 previous months,
- •Subject having a cutaneous-mucosal disease liable to interfere with study data according to the investigator, especially: herpes or medical history herpes, aphtous and medical history of aphtous, lichen planus, chronic lupus erythematosis,
- •Subject having undergone surgery, chemical or physical treatment to the concerned study area in the last 3 months,
- •Subject allergic or intolerant to one of the components of the study product,
- •Subject having a background of intolerance or allergy to cosmetics, drugs or to other substances (fruits, lactose intolerant, nuts, etc.),
- •Subject planning to have any dental care during the study.
- •Subject having a treatment liable to interfere with study data (aspirin or derivatives, anti-inflammatories, and other analgesic, antibiotics, antihistaminics, corticoids, desensitizing substances, immunosuppressants, calcic inhibitors and anticonvulsants) 2 days before the inclusion visit,
- •Subject having used of over the counter product for dentinal hypersensitivity within the previous six weeks,
- •Subject being vaccinated (4 weeks prior) or expecting to be vaccinated during the study,
- •Subject having modified his/her cosmetic habits (on the areas concerned by the study) during the last 2 weeks,
- •Subject having applied any local product the day of the inclusion visit on the study area except the usual toothpaste
结局指标
主要结局
Global tolerance according to a 5-point grading scale taking into account physical signs observed and graded by the dentist and functionnal signs observed and graded by the patient
时间窗: after 28 days
The global tolerance of the product is assessed by the dentist after 28 days of use, rated on a 5-point grading scale(good tolerance, very good tolerance, good tolerance, moderate tolerance) . The results of the global tolerance will take into account the physical signs observed by the dentist and the functional signs observed by the patients during the study
次要结局
- Tolerance with the record of functionnal signs reported by the dentist and physical signs reported by the patient.(during 28 days)
- Acceptability of the product assessed with a questionnaire(during 28 days)
- Cold air stimulus score on the schiff cold air index as a mesure of immediate efficacy(5 and 60 minutes after application at day 1)
- Cold air stimulus score on the schiff cold air index as a mesure of efficacy(between baseline and day 28)
- Cold air stimulus score on the schiff cold air index as a mesure of short term efficacy(efficacy at day 4 and day 6)
研究者
研究点 (2)
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