Remineralization Potential of Curodont Repair Flouride Plus Versus CPP-ACP in Management of White Spot Lesions: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Remineralization potential
研究概览
简要总结
The goal of modern dentistry is to manage non-cavitated caries lesions non- invasively through re-mineralization process to prevent the disease progression and improve aesthetics, strength, and function. Re-mineralization is defined as the process that supplies calcium, phosphate and flouride ions from an external source to the tooth to convert ion deposition into crystal voids in demineralized enamel. White spot lesions should be managed using a multifactorial approach. The most important strategy is to prevent demineralization and biofilm formationand use of methodologies for remineralization of lesions .
Self-assembling peptide (P11-4) has shown great potential for natural repair of early caries lesions through emerging biomimetic re-mineralization properties. (Takahashi Fet al in 2015) This peptide forms a 3D matrix within demineralized carious lesions areas, which enables novo hydroxyapatite crystal formation facilitating the so-called guided enamel regeneration of the lost enamel structure. The peptide has shown encouraging results as a scaffold for enamel regeneration
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
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between the ages of 18 and 35 years of age female and males
- •Had received conventional periodontal therapy
- •Active carious white spot lesions
- •No systemic diseases or concomitant medication affecting salivary flow
排除标准
- •- Participant in another trial
- •Non carious lesion (enamel hypoplasia and dental flourosis)
- •Presence of abnormal oral, medical, or mental condition.
- •Participants who had evidence of reduced salivary flow or significant tooth wear.
- •Allergy to MI paste
研究组 & 干预措施
Self assembling peptide with fluoride
干预措施: Self assembling peptide with fluoride (Drug)
Casein-phosphopeptide/amorphous-calcium phosphate
干预措施: Self assembling peptide with fluoride (Drug)
结局指标
主要结局
Remineralization potential
时间窗: T0:baseline assessment -->T1:1 month (Assessment of white spot lesion regression)--> T2:4 months(Application of Curodont repair flouride plus /Cpp-Acp andAssessment of white spot lesion regression)--> T3: 6 months Assessment of white spot lesion regres(
by: Inspection under magnification ICDAS II Score 0:Sound tooth surface: 1. First visual change in enamel. 2. Distinct visual change in enamel visible when wet, lesion must be visible when dry.
次要结局
- Remineralization potential(T0:baseline assessment -->T1:1 month (Assessment of white spot lesion regression)--> T2:4 months(Application of Curodont repair flouride plus /Cpp-Acp andAssessment of white spot lesion regression)--> T3: 6 months( Assessment of white spot lesion regres)
研究者
Nada Hamada Ahmed Shehab Eldin
resident at operative dentistry department, Cairo university
Cairo University