Indirect Pulp Capping, Direct Pulp Capping, Partial Pulpotomy, Pulpotomy of Primary Molars Using TheraCal; A Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Changes in Visual and tactile clinical examination
研究概览
简要总结
The study is a clinical trial that assesses the clinical and radiographic success rates of 3 conservative pulp therapy treatments in primary molars compared to conventional pulpotomy using a bioactive dual cured calcium silicate cement (TheraCAL PT).
详细描述
Participating Children will be recruited from the outpatient's clinic of pediatric dentistry department , Faculty of Dentistry Ain Shams University and will be allocated to one of the following groups; Indirect pulp capping, direct pulp capping, partial pulpotomy or pulpotomy. TheraCAL PT, a dual cured tricalcium silicate cement will be used in all groups as the pulp capping material. Children will be followed every 6 months for a period of 1 year to evaluate clinical and radiographic success.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Four to six years old healthy children
- •Cooperative (frankle scale + and ++)
- •With at least one vital and restorable primary molar with deep caries.
排除标准
- •History of spontaneous pain, swelling, or sinus tract
- •Pathological mobility
- •pain on percussion
- •Furcation or periapical radiolucency
- •Internal or external pathological root resorption
- •Widening of periodontal membrane space
- •Discontinuity of lamina dura.
研究组 & 干预措施
indirect pulp capping
TheraCAL PT will be applied to affected dentin covering the pup.
干预措施: Dual cured resin modified tricalcium silicate cement (Drug)
Direct pulp Capping
TheraCAL PT will be applied to pinpoint pulp exposures surrounded by sound dentin.
干预措施: Dual cured resin modified tricalcium silicate cement (Drug)
Partial Pulpotomy
Pulp exposure will be enlarged to a depth of 1-3 mm by a sterile round diamond bur, and then TheraCAL PT will applied after hemostasis.
干预措施: Dual cured resin modified tricalcium silicate cement (Drug)
pulpotomy
complete removal of coronal pulp tissue will be attempted if bleeding persisted after attempting Partial pulpotomy for exposures that are not eligible for DPC. TheraCAL PT will be applied thereafter, after achieving hemostasis.
干预措施: Dual cured resin modified tricalcium silicate cement (Drug)
结局指标
主要结局
Changes in Visual and tactile clinical examination
时间窗: every 6 months
Teeth will examined for any clinical signs of irreversible pulpitis or pulp necrosis
次要结局
- Change in Dental Periapical Radiographic examination(every 6 months)
研究者
Mariem Wassel
Assistant professor of pediatric dentistry
Ain Shams University