Clinical and Topographic Evaluation of the Remineralizing Potential of Biomimetic Scaffolds on Enamel White Spot Lesions (a Randomized Controlled Clinical Trial and In-vitro Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- change in ICDAS scores
研究概览
简要总结
The modern concept in caries treatment focuses on the non-invasive approach and on the biomimetic remineralization of early non-cavitated white spot carious lesions. Recently developed biomimetic scaffolds attempt to remineralize the dental tissues and are more regenerative than reparative.
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)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who at least have 1 white spot lesion.
- •No systemic diseases or taking any medication affecting salivary flow.
- •Patients with good oral hygiene measures.
- •Patients with moderate caries risk assessment.
- •Post orthodontic WSLs with International Caries Detection and Assessment System (ICDAS II) scoring criteria (1-2).
排除标准
- •Participant in another trial.
- •Developmental non carious lesion (enamel hypoplasia and dental fluorosis).
- •Presence of abnormal oral disease, or medically compromised patients.
- •Participants who had evidence of reduced salivary flow or significant tooth wear.
- •Allergy to milk products or other drug allergies.
结局指标
主要结局
change in ICDAS scores
时间窗: Baseline, 1 month, 3 months , 6 months, 9 months, 12 months
Code Description 0: Sound tooth surface: No evidence of caries after 5 sec air drying 1. First visual change in enamel: Opacity or discoloration (white or brown) is visible at the entrance to the pit or fissure seen after prolonged air drying 2. Distinct visual change in enamel visible when wet, lesion must be visible when dry 3. Localized enamel breakdown (without clinical visual signs of dentinal involvement) seen when wet and after prolonged drying 4. Underlying dark shadow from dentine 5. Distinct cavity with visible dentine 6. Extensive (more than half the surface) distinct cavity with visible dentine
Change in DIAGNOdent values
时间窗: Baseline, 1 month, 3 months , 6 months, 9 months, 12 months
The DIAGNOdent uses laser fluorescence to aid in the detection of caries within the tooth structure.
次要结局
未报告次要终点
研究者
Hams Hamed Abdelrahman
Assistant lecturer of DPH and Clinical statistician
Alexandria University