Experimental Research on Deep Carious Lesion Treatment of Permanent Molars in Children, Aiming to Preserve Dental Pulp Vitality
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Clinical pulpal survival rate
研究概览
简要总结
Maintaining dental pulp vitality is crucial for tooth preservation and functionality. Untreated dental caries may lead to pulp necrosis and infection, affecting children's growth and well-being. The first permanent teeth erupt around 6 years old. These are the first molars (FPM), which are frequently affected by caries, soon after their eruption.
In the present application, our main goal is to determine whether two treatment groups (MTA and TheraCal) are long-term effective in preserving pulp vitality among children' FPM affected by deep caries.
详细描述
Among the most frequently used materials for pulp capping are calcium hydroxide, mineral trioxide aggregate (MTA), and, more recent, TheraCal. All of them are biocompatible and induce the formation of coronal hard tissue barriers (tertiary reparative dentin). Calcium hydroxide, considered for a long time the gold standard of direct pulp capping materials, has excellent antibacterial and remineralisant properties; however, it lacks adhesion, especially at moist dentin, and reparative dentin is less homogenous.
MTA proved to stimulate protective dentin bridge formation without inflammatory changes and least necrosis. It is also moisture tolerant, but it is more expensive, has poor handling characteristics and slow setting time.
TheraCal bonds to deep moist dentin, has strong physical properties, no solubility, high radioopacity and higher calcium releasing abilities than MTA or calcium hydroxide.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •untreated deep uncomplicated carious lesions in first permanent molars (FPM)
- •absence of clinical diagnosis of pulp exposure
- •swelling of periodontal tissues
- •abnormal tooth mobility
- •history of spontaneous pain or sensitivity to percussion
- •healthy appearance of adjacent gingiva
- •normal tooth color
- •positive vitality to thermal and electric tests.
排除标准
- •FPM with previous treatment
- •FPM with developmental abnormalities (such as enamel hypoplasia, dentinogenesis imperfecta etc.)
- •children with mental disabilities or systemic diseases.
结局指标
主要结局
Clinical pulpal survival rate
时间窗: 20 months
Pulpal survival is defined by positive response without lingering sensation to the cold test, absence of clinical signs and symptoms, and no apical radiolucency on the periapical radiograph.
次要结局
- Incidence of apical root maturation (apexogenesis)(20 months)
研究者
Andreea Didilescu, DDS
Vice dean for Research, Professor
Carol Davila University of Medicine and Pharmacy