Indirect Pulp Capping Versus Pulpotomy With MTA for Treatment of Primary Molars With Deep Caries: An Equivalent Parallel Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Clinical and radiographic evaluation
研究概览
简要总结
The aim of the current randomized controlled trial is to evaluate clinical and radiographic outcomes of indirect pulp capping and pulpotomy with MTA in treatment of primary teeth with deep caries over a 12-month follow-up period.
详细描述
Output patients coming to Pediatric dentistry department Minia University, selected randomly to evaluate clinical and radiographic outcomes of indirect pulp capping and pulpotomy with MTA in treatment of primary teeth with deep caries over a 12-month follow-up period an equivalent parallel randomized controlled trial
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)
盲法说明
Double
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- 4 to 6 years old patients presented with deep carious lesions in primary molars.
- •Apparently healthy children (ASA I, II classification).
- •Co-operative children (Rating 3 & 4 according to Frankle classification)
排除标准
- •A) Clinical:
- •Non restorable primary molars.
- •Presence of clinical pathology.
- •Presence of mobility or tenderness to percussion.
- •Spontaneous pain.
- •B) Radiographic:
- •Pre-operative radiographs showed external or internal root resorption.
- •Presence of furcal radiolucency.
- •Presence of periapical radiolucency or widened periodontal ligament space
- •More than one-third root resorption detected.
结局指标
主要结局
Clinical and radiographic evaluation
时间窗: 2 years follow up
The children will be recalled for postoperative clinical and radiographic assessment at the following intervals: 3, 6, 12 months the treatment will be considered successful if none of the following clinical or radiographic findings is present: Clinical criteria: 1. pain 2. tenderness to palpation or percussion 3. gingival swelling or sinus tract 4. purulent exudate expressed from the gingival margin 5. abnormal tooth mobility Radiographic criteria: 1. periapical radiolucency 2. widening in peridontal ligament space
次要结局
未报告次要终点
研究者
Hasnaa monis
Resident in pediatric dentistry department faculty of dentistry assuit university
Assiut University