A Comparison Between a Toothpaste With Micro Crystals of Hydroxyapatite and a Toothpaste With 1450 Ppm of Fluoride in the Home Remineralization of White Spot Lesions: a Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in VAS score
研究概览
简要总结
The aim of the study is to compare white spot lesions before, during and after treatment with New Biorepair Advanced Sensitive toothpaste containing micro crystals of hydroxyapatite and Colgate toothpaste with 1450 ppm of fluoride. The timeline will consider the study begin, 15 days, 30 days and 90 days after the beginning of the study. The following indices will be recorded: BEWE Index, Schiff Air Index, VAS scale. After that, patients will fill in a satisfaction questionnaire.
详细描述
The aim of the study is to compare white spot lesions before, during and after treatment with two different toothpastes for home oral care. Patients who agree to sign the informed consent will be randomly assigned to two different groups:
- Trial Group will use New Biorepair Advanced Sensitive toothpaste containing micro crystals of hydroxyapatite;
- Control Group will use Colgate toothpaste with 1450 ppm of fluoride.
At the baseline, professional oral hygiene will be performed. The following indices will be recorded at the study begin and at the following 15, 30 and 90 days: BEWE Index, Schiff Air Index, VAS scale. After that, patients will fill in a satisfaction questionnaire.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •patients with white spot lesions;
- •patients with dental sensibility;
- •adult patients;
- •patients that sign the informed consent to participate to the study.
排除标准
- •patients with low compliance or motivation to participate to the study;
- •patients not presenting white spot lesions;
- •patients with absence of dental sensibility;
- •patients pregnant or breastfeeding;
- •underage patients;
- •patients with psychiatric diseases.
研究组 & 干预措施
Trial Group
Use of New Biorepair Advanced Sensitive toothpaste for home oral care.
干预措施: Biorepair toothpaste (Other)
Control Group
Use of Colgate toothpaste for home oral care.
干预措施: Colgate toothpaste (Other)
结局指标
主要结局
Change in VAS score
时间窗: Study begin, 15, 30 and 90 days.
Evaluation of the evoked pain with air blasting from 0 to 10. The VAS scale is a straight line with the endpoints defining extreme limits with "no pain at all"and "pain as bad as it could be"; they correspond respectively to 0 and 10. The patient indicates the score of the perceived pain from 0 to 10.
Change of the BEWE Index - Basic Erosive Wear Examination (Barlet et al., 2008)
时间窗: Study begin, 15, 30 and 90 days.
Scoring criteria: 0: no erosive tooth wear; 1. initial loss of surface texture; 2. distinct defect, hard tissue loss \< 50% of the surface area; 3. hard tissue loss ≥ 50% of the surface area.
Change in Schiff Air Index - Dental sensitivity test
时间窗: Study begin, 15, 30 and 90 days.
Scoring criteria: 0: the subject did not respond to air blasting; 1. the subject responded to air blasting; 2. the subject responded to air blasting and requested discontinuation; 3. the subject responded to air blasting, requested discontinuation and considered the stimulus to be painful.
次要结局
未报告次要终点
研究者
Andrea Scribante
Research Resident, Principal Investigator
University of Pavia