Clinical and Radiographic Evaluation of Light Cured Resin Modified Calcium Silicate Versus Light Cured Calcium Hydroxide in Indirect Pulp Treatment of Primary Molars
试验速览
- 阶段
- 4 期
- 入组人数
- 46
- 主要终点
- Postoperative pain
研究概览
简要总结
The objective of this study is to explore if light cured resin modified Calcium silicate could result in better clinical and radiographic success if compared to light cured Calcium hydroxide when used in indirect pulp capping treatment in primary molars.
详细描述
To evaluate clinical and radiographic success of resin modified calcium silicate in comparison to light cured calcium hydroxide as indirect pulp capping materials in primary molars.
P: Children aged (4-7 years) with deep carious lesions in lower primary second molars indicated for indirect pulp treatment.
I: Indirect pulp treatment using light cured resin modified Calcium Silicate (TheraCal).
C: Indirect pulp treatment using light cured Calcium Hydroxide. O: clinical and radiographic success.
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
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medically free children.
- •Age range from 4-7 years.
- •Presence of lower second primary molars with deep carious occlusal lesion.
- •No history of spontaneous pain (reversible pulpitis).
- •Clinically: Absence of swelling, sinus, fistula, pain on percussion and tooth mobility.
- •Radiographically: Absence of radiolucent lesions at furcation or periapical region and absence of internal or external root resorption.
排除标准
- •Uncooperative children.
- •Any unmet previous criterion.
研究组 & 干预措施
Resin Modified Calcium Silicate
light-cured resin-modified calcium silicate-filled base/ liner material designed for direct and indirect pulp capping
干预措施: Calcium silicate liner (Drug)
Light Cured Calcium Hydroxide
gold standard for pulp capping, It allows for the formation of a reparative dentine bridge through cellular differentiation, extracellular matrix secretion and subsequent mineralization.
干预措施: Calcium hydroxide liner (Drug)
结局指标
主要结局
Postoperative pain
时间窗: 12 months
Pain questionnaire (binary yes/no)
次要结局
- Tooth mobility(12 months)
- widening in the periodontal membrane space(12 months)
- Swelling(12 months)
- Sinus or fistula(12 months)
- Occurrence of radiolucent lesions at furcation or periapical region(12 months)
- pain on percussion(12 months)
- presence of internal or external root resorption(12 months)
研究者
Yasmine Ashraf Elbanna
Assistant lecturer
Cairo University