Comparative Evaluation of the Remineralizing Ability of Self-Assembling Peptide P11-4, 2% Arginine Enriched Sodium Fluoride and Functionalized Tri Calcium Phosphate Fluoride Varnishes in Treatment of White Spot Lesions (Randomized Clinical Trial and In Vitro Study)
试验速览
- 阶段
- 不适用
- 入组人数
- 39
- 主要终点
- dimensional and color assessment
研究概览
简要总结
The aim of the current study is to compare the remineralizing ability of Self-assembling peptide P11-4, 2% Arginine Enriched Sodium Fluoride and Functionalized Tri Calcium Phosphate Fluoride varnishes in treatment of white spot lesions both in-vivo and in-vitro .
A) Primary Objective
Assessment of:
- Dimensions of the WSLs through digital photography.
- The color of WSLs through spectrophotometer. B) Secondary Objectives
Assessment of:
• Degree of remineralization using Polarized Light Microscope.
详细描述
White spot lesions (WSLs), defined as "white opacity," occur as a result of subsurface enamel demineralization that is located on smooth surfaces of teeth. The reason of the white appearance is the changes in light-scattering optical properties of the decalcified enamel. The aim of the current study is to compare the remineralizing ability of Self-assembling peptide P11-4, 2% Arginine Enriched Sodium Fluoride and Functionalized Tri Calcium Phosphate Fluoride varnishes
A) Primary Objective
Assessment of:
- Dimensions of the WSLs through digital photography.
- The color of WSLs through spectrophotometer. B) Secondary Objectives
Assessment of:
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 (Participant)
盲法说明
double
入排标准
- 年龄范围
- 8 Years 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Self-assembling peptide P11-4 varnish (study group)
- Test lesions will be wiped with NaOCl to remove pellicle,
- Etched for 20 s with 35% H3PO4 Etching Gel to remove mineral deposits on the tooth surface and rinsed with water in accordance with the manufacturer's instructions.
- The lesions will be dried and isolated with cotton rolls.
- The varnish will be applied and left undisturbed for 5minutes (till disappearance) to allow diffusion of self-assembly.
干预措施: curodont (Drug)
Arginine-enriched Sodium Fluoride varnish (study group)
- The Arginine powder will be suspended at 2%.
- A 10 mL of 5% sodium fluoride varnish tube dispensed in a sterile container.
- 200 mg of Arginine will be vigorously mixed with the varnish matrix for 60 sec using a sterile microbrush.
- After dryness of the white spot lesion, the prepared varnish will be applied evenly using the micro brush.
- After application the patient will be instructed to avoid rinsing, eating soft diet and avoid hot drinks for 2 hrs.
干预措施: curodont (Drug)
Tri Calcium Phosphate Fluoride varnish (positive control group)
- To limit undesirable oral ingestion, the appropriate dose for the patient will be determined with the help of the dosing guide.
- The varnish will be mixed with the brush to avoid separation of the material during storage
- However, to guarantee the best results suction will be used during application of the varnish.
- A thin uniform layer of the varnish will be applied on the lesion surface by using the supplied brush
- The applicator brush won't be moved through accumulated saliva to prevent premature setting on the bristles.
- After application the patient will be instructed to close his mouth, avoid rinsing, eating soft diet and avoid hot drinks for 4 hrs.
All patients will be encouraged to maintain good oral hygiene through regular brushing.
干预措施: curodont (Drug)
结局指标
主要结局
dimensional and color assessment
时间窗: 1. Baseline 2. 3-month evaluation 3. 6-month evaluation 4. 9-month evaluation
Photographic assessment and color change reading outcomes will be assessed by two other blinded calibrated examiners
次要结局
- Evaluation of the remineralizing ability and degree of remineralization of each agent(1 month)
研究者
bardis Sslah
assistant lecturer
Ain Shams University
