Clinical Effectiveness of Bioactive Silica Based With Calcium Toothpaste, Sodium Fluoride Varnish in Management of White Spot Lesions (A 6m Randomized Clinical Trial).
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Degree of Remineralization efficacy by Diagnodent
研究概览
简要总结
This study will be conducted to Clinically evaluate Bioactive Silica Based with calcium booster (Refix technology) toothpaste and Sodium Fluoride varnish versus conventional fluoride toothpastes in management of white spot lesions of adult patients over 6m follow up and evaluating patient perception regarding the treatment provided.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient with non cavitated carious WSL in at least one upper or lower tooth.
- •Teeth with active non cavitated white spot carious lesions on the cervical one third of the facial or lingual surfaces.
- •Teeth with initial carious lesions with score 1 or 2 according to The International Caries Detection and Assessment System (ICDAS).
- •Teeth with Diagnodent values between 14-20 that refers to early enamel caries.
排除标准
- •Patients with known allergies or adverse reactions to any ingredient of the tested materials.
- •Systematic disease and/ or physical disabilities that may affect participation.
- •Patients with white spots due to congenital reasons e.g. enamel hypomineralization.
- •Pregnant females with frequent vomiting attacks.
- •Excessive dietary or environmental exposure to acids.
- •Presence of surface cavitation or restorations .
研究组 & 干预措施
Group (3) Signal Complete 8 ; Conventional 1425 ppm fluoride toothpaste:
The patients will be taught in the intervention visit and instructed to use the same 1 inch amount of the toothpaste and soft bristle toothbrushes with the same brushing technique they for 2 minutes twice a day (morning and last thing at night) along the study period without further rinsing, only spitting of the excess material.
干预措施: Toothpaste Product (Procedure)
Group 1 Refix Booster: Bioactive Silica Based (Refix technology) with calcium booster toothpaste
The patients will be taught in the intervention visit and instructed to use the same 1 inch amount of the two toothpastes, mix them and apply it on a soft bristle toothbrushes with the same brushing technique they for 2 minutes twice a day (morning and last thing at night) along the study period without further rinsing, only spitting of the excess material.
干预措施: Toothpaste Product (Procedure)
Group 2 Polimo: 5% Sodium Fluoride varnish
The tooth will be dried, and cotton roll isolated. According to manufacturer instructions, thin coat of the varnish will be applied on the teeth for 10 - 20 s using a microbrush in a horizontal sweeping motion , then drying with air will be done. Patients will be instructed to avoid food and liquid intake for two hours after varnish application also, to use conventional 1425 ppm fluoride toothpaste at home with the same instructions mentioned before.
干预措施: Varnishes, Fluoride (Procedure)
结局指标
主要结局
Degree of Remineralization efficacy by Diagnodent
时间窗: change from the baseline, 1month, 3 months , 6 months after treatment
DIAGNOdent calibration will be performed first then the tip of the probe will be positioned on the lesion and rotated around its vertical axis until the highest value will be reached and a peak reading will be recorded
次要结局
- Carie Progression according to International Caries Detection and Assessment System (ICDAS) scale:(change from the baseline, 1month, 3 months , 6 months after treatment)
- Patient-reported outcome measures (PROMs): Patients perception of the treatment(change from the baseline, 1month, 3 months , 6 months after treatment)
研究者
Rawda Hesham Abd ElAziz
Associate Professor, Conservative dentistry department
Cairo University