A Multicentric Observational Single Arm Study To Evaluate The Effectiveness Of Toothpaste Containing Fluoro Calcium Phosphosilicate (Biomin) In The Long-Term Relief Of Dentine Hypersensitivity
概览
- 阶段
- Post Marketing Surveillance
- 状态
- 已完成
- 发起方
- Dr Amit Mishra
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- 1. To evaluate change in dentine hypersensitivity post-treatment with fluoro-calcium phosphosilicate toothpaste at Week 6.
概览
简要总结
This is aprospective, multicenter, single-arm, open-label, investigator-initiated study designed to assess the effectiveness and safety of fluoro-calcium phosphosilicate containing toothpaste in the management of dentine hypersensitivity. The study population will include out-patients of both sexes, with dentin hypersensitivity visiting the dental clinics, Shataayu Dental Clinic, Scheme no. 103, Plot No. 76, Kesar Bagh Road, Indore, Madhya Pradesh, India, or Thaper Dental Clinic 1, Navjeevan Chamber, Vinobha Marg, Panch Batti, C Scheme, Ashok Nagar, Jaipur, Rajasthan India; and are clinically indicated for the treatment with toothpaste containing fluoro-calcium phosphosilicate, as per the discretion of the investigator. It is expected that approximately 120 patients with dentin hypersensitivity will be enrolled in the study.
At baseline (Visit 1 [Day 0]), patients with dentine hypersensitivity will be evaluated for cold stimulus scores, assessed bythe Schiff Cold Air Sensitivity Scale (SCASS) score, the subjective impact of dentine hypersensitivity on the patient’s quality of life (QoL) life by 15 items Dentine Hypersensitivity Experience Questionnaire (DHEQ-15) score and participants’ pain score on a 10-point visual analog scale (VAS). The patient will continue receiving the investigational product Hydent Pro toothpaste for the period of 24 weeks, as per the discretion of the investigator and according to the study protocol. Progress made by the patient will be reviewed in clinical on Weeks 4,6,8,12,16, and 24.
研究设计
- 研究类型
- Pms
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Patients of either sex in the age group of 18 to 70 years.
- •Patients with a self-reported history of dentinal hypersensitivity and prescribed toothpaste containing fluorocalcium phosphosilicate by the Investigator.
- •No clinically significant or relevant abnormalities in medical history or upon oral examination, or condition that would impact the participants safety, wellbeing, or the outcome of the study.
- •Any 2 or more teeth with signs of sensitivity measured by a qualifying evaporative air assessment (Schiff sensitivity score greater than or equal to 2) 6.Patients willing to participate in the study and sign an informed consent form.
排除标准
- •Individuals either with active dental caries, heavily restored, or cracked teeth, or with orthodontic or prosthetic appliances, or with localized or generalized gingivitis or pulpitis and heavy calculus or using any desensitizing toothpaste or mouthwash or any other desensitizing products up to two weeks before the start of the study.
- •Patients who have undergone vital teeth bleaching within two weeks, before the screening date.
- •Pregnant and nursing women.
- •Women with childbearing potential not practicing a reliable method of birth control.
- •Patients with a known history of hypersensitivity to ingredients of investigational product.
- •Suspected inability or unwillingness to comply with study procedures.
结局指标
主要结局
1. To evaluate change in dentine hypersensitivity post-treatment with fluoro-calcium phosphosilicate toothpaste at Week 6.
时间窗: Day 0 and Week 6
次要结局
- 1. To evaluate the change in dentine hypersensitivity post-treatment with fluoro-calcium phosphosilicate toothpaste from baseline to Weeks 4, 8, 16, and 24.(2. To monitor the oral health-related quality of life (QOL) as measured by the Dentine Hypersensitivity Experience Questionnaire-15 (DHEQ-15) post-treatment with fluoro-calcium phosphosilicate toothpaste.)
研究者
Dr Amit Mishra
Shataayu Dental Clinic