Clinical and Radiographic Comparison of Indirect Pulp Treatment and Direct Pulp Capping in Deep Carious Primary Second Molars: One-Year Results
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Clinical success of indirect pulp treatment and direct pulp capping
研究概览
简要总结
The purpose of this randomized controlled clinical trial was to compare the clinical and radiographic outcomes of indirect pulp treatment (IPT) and direct pulp capping (DPC) using mineral trioxide aggregate (MTA) in deep carious primary molars. Children with deep dentin caries in primary molars were randomly assigned to receive either IPT or DPC. Clinical and radiographic evaluations were performed at 6 and 12 months to assess treatment success. The findings of this study aim to provide evidence-based guidance for the management of deep dentin caries in primary teeth.
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
- None
入排标准
- 年龄范围
- 7 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systemically healthy children aged 7 to 9 years
- •Primary second molars with deep dentin caries indicated for vital pulp therapy
- •Absence of clinical signs or symptoms of irreversible pulpitis
- •No spontaneous or prolonged pain
- •Teeth with no tenderness to percussion or palpation
- •No pathological mobility, swelling, fistula, or abscess
- •Radiographic findings showing intact lamina dura and normal periodontal ligament space
- •Absence of periapical or furcation radiolucency
- •No evidence of pathological internal or external root resorption
- •Teeth considered restorable
- •Written informed consent obtained from parents
排除标准
- •Children with systemic diseases or medical conditions affecting healing
- •Teeth with signs or symptoms of irreversible pulpitis
- •Presence of spontaneous pain, night pain, or prolonged pain
- •Teeth with periapical or furcation radiolucency
- •Teeth with pathological internal or external root resorption
- •Presence of pulpal calcifications or pulp stones
- •Non-restorable teeth
- •Lack of parental consent
研究组 & 干预措施
Indirect Pulp Treatment (IPT)
Teeth allocated to this arm received indirect pulp treatment. Selective caries removal was performed, leaving affected dentin over the pulp, followed by placement of mineral trioxide aggregate (MTA) and restoration with a stainless steel crown (SSC).
干预措施: Indirect Pulp Treatment (Procedure)
Direct Pulp Capping (DPC)
Teeth allocated to this arm received direct pulp capping. After <1 mm pulp exposure, mineral trioxide aggregate (MTA) was placed directly over the exposed pulp tissue, followed by restoration with a stainless steel crown (SSC).
干预措施: Direct Pulp Capping (Procedure)
结局指标
主要结局
Clinical success of indirect pulp treatment and direct pulp capping
时间窗: 12 months
Clinical success was defined as the absence of spontaneous pain, swelling, fistula, pathological mobility, or tenderness to percussion.
Radiographic success of indirect pulp treatment and direct pulp capping
时间窗: 12 months
Radiographic success was defined as the absence of periapical radiolucency, internal or external root resorption, pathological changes, or other radiographic signs of pulpal or periapical pathology during the follow-up period.
次要结局
- Effect of pulp exposure location on treatment success(12 months)
研究者
Ozlem Beren SATILMIS
Principal Investigator
Ankara University