Evaluation of Indirect Pulp Capping in Children With Different Materials
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 主要终点
- Clinical success rates of the indirect pulp capping biomaterials
研究概览
简要总结
Indirect pulp capping (IPC) is a treatment that preserves pulp's vitality. Several materials have been used for this procedure. The aim of this study is to evaluate the radiographic and clinical outcomes of TheraCal LC (Bisco Inc., Schaumburg, IL, USA) and to compare it with mineral trioxide aggregate (MTA) (Pro Root MTA, Dentsply Tulsa, Johnson City, TN, USA) and calcium hydroxide [Ca(OH)2] (Dycal, Dentsply De Trey Konstanz, Germany) biomaterials in IPC treatment.
详细描述
A total of 295 teeth, including second primary molars and first permanent molars with IPC indications from healthy and cooperative children between the ages of 4-15, were included in this study. Teeth were divided into three groups according to the materials used for pulp capping. Indirect pulp treatment was applied using Dycal for 91 teeth, ProRoot MTA for 89 teeth and TheraCal LC for 115 teeth. Primary molars were restored with the compomer material, and permanent molars were restored with the resin composite material. Restorations were evaluated with the Modified United States Public Health Service (modified USPHS) criteria. Clinical and radiographic findings were evaluated for 24 months at follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •teeth with clinical and radiographical indications of indirect pulp capping
- •systemically healthy and cooperative children
排除标准
- •teeth with contraindications of indirect pulp capping: Clinical Exclusion Criteria
- •Pain (spontaneous and chronic)
- •Acute pulpal inflammation
- •Pain with percussion
- •Pathologic mobility
- •Devitality symptoms (negative response to thermal pulp test) Radiographic Exclusion Criteria
- •Progression of caries lesion to pulp
- •Perforation of pulp
- •Intermittent or irregular lamina dura
- •Expanded range of periodontal ligament
- •Periapical radiolucency
- •Internal and external resorption
- •systemically unhealthy and uncooperative children
研究组 & 干预措施
Calcium Hydroxide (Dycal)
Indirect pulp capping treatment with Calcium Hydroxide
干预措施: Calcium Hydroxide (Drug)
Calcium Hydroxide (Dycal)
Indirect pulp capping treatment with Calcium Hydroxide
干预措施: Mineral Trioxide Aggregate (Drug)
Calcium Hydroxide (Dycal)
Indirect pulp capping treatment with Calcium Hydroxide
干预措施: TheraCal LC (Drug)
Mineral Trioxide Aggregate (ProRoot MTA)
Indirect pulp capping treatment with Mineral Trioxide Aggregate
干预措施: Calcium Hydroxide (Drug)
Mineral Trioxide Aggregate (ProRoot MTA)
Indirect pulp capping treatment with Mineral Trioxide Aggregate
干预措施: Mineral Trioxide Aggregate (Drug)
Mineral Trioxide Aggregate (ProRoot MTA)
Indirect pulp capping treatment with Mineral Trioxide Aggregate
干预措施: TheraCal LC (Drug)
Theracal LC
Indirect pulp capping treatment with Theracal LC
干预措施: Calcium Hydroxide (Drug)
Theracal LC
Indirect pulp capping treatment with Theracal LC
干预措施: Mineral Trioxide Aggregate (Drug)
Theracal LC
Indirect pulp capping treatment with Theracal LC
干预措施: TheraCal LC (Drug)
结局指标
主要结局
Clinical success rates of the indirect pulp capping biomaterials
时间窗: 24 months
No pathological symptom like abscess, fistulas or pain at percussion
次要结局
- Success rates according to Modified USPHS criterias(24 months)
- Radiographical success rates of the indirect pulp capping biomaterials(24 months)
研究者
Aliye Tugce Gurcan
Assist. Prof.
Altinbas University