Radiographic and Clinical Evaluation of Indirect and Direct Pulp Capping in Primary Molars Using TheraCal (LC)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- recording signs and symptoms through clinical examination
研究概览
简要总结
A randomized clinical trial that aims to evaluate clinical and radiographic success rates of indirect pulp capping and direct pulp capping in primary molars with reversible pulpitis using a light-cured tri-calcium silicate base material (TheraCal (LC)).
详细描述
Participating primary molars will be randomly allocated to one of the following groups: Indirect pulp capping group or Direct pulp capping group. A light-cured tri-calcium silicate base material (TheraCal (LC) ) will be used in the two groups as a dressing material. Patients will be recruited from the outpatient clinic of the pediatric dentistry department, Faculty of Dentistry Ain Shams University. The participant will be recalled for follow-up assessments at 3, 6,9, and 12 months.
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
The participants and the outcome assessor were blinded. The primary investigator blinding was impossible
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
- •Age: 4-7 years.
- •Free medical history.
- •Complete physical and mental health.
- •Patient cooperation
- •restorable mandibular primary molars
排除标准
- •Clinical symptoms or irreversible pulpitis as (spontaneous pain, throbbing pain)
- •Soft tissue swelling, draining fistula or sinus tracts.
- •Tenderness to percussion.
- •Pathological Tooth mobility.
- •Widening of periodontal membrane space
研究组 & 干预措施
Indirect Pulp Capping
TheraCal (LC) will be applied to affected dentin after excavation of infected dentin
干预措施: Light cured tri-calcium silicate base material (Drug)
Direct Pulp Capping
TheraCal (LC) will be applied to pinpoint pulp exposures (less than 1mm ) in vital pulps surrounded by sound dentin.
干预措施: Light cured tri-calcium silicate base material (Drug)
结局指标
主要结局
recording signs and symptoms through clinical examination
时间窗: one year follow-up
All the primary molars participating in this study will be examined clinically under the illumination of dental unit, percussion and palpation test will be performed to ensure absence of any sign and symptoms of irreversible pulpitis or nectrotic pulp during follow -up period.
次要结局
- recording pathological Changes in Radiographic examination(one year follow-up)
- Evaluation of TheraCal (LC) as a pulp capping material(one year follow-up)
研究者
Yomna Hussein Moselhy
Principle investigator
Ain Shams University