Clinical and Radiographic Evaluation of Three Biomimetic Materials in Pulp Therapy of Immature Young Permanent Teeth "A Randomized Controlled Clinical Trial"
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Clinical success
研究概览
简要总结
Statement of the problem:
Pulpotomy is the most popular technique for maintaining vitality and has a substantial impact on continuing root growth in vital, young permanent molars suffering from dental cavities.
Biomimetic materials placement after performing pulp therapy is one of the important factors to determine healing of the pulp and continue root formation. In this study a novel material "Treated Dentin Matrix" is used in comparison to premixed bioceramic material and "Mineral Trioxide Aggregate" in pulpotomy of immature permanent molars.
The Aim of the study:
Is to assess the clinical and radiographic success of pulpotomized first permanent immature molars treated with three different Biomimetic materials (Treated Dentin Matrix, Premixed Bio-ceramic material and Mineral Trioxide Aggregate)
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
- 7 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged between 7 and 10 years-old.
- •Vital permanent first molars with deep caries lesion approaches the pulp without symptoms of irreversible pulpitis, with open apices in the radiograph.
- •Permanent first molars with pulpal exposure that occurred during caries excavation.
- •Incompletely formed roots
排除标准
- •Teeth with signs and symptoms of chronic infection such as swelling and mobility.
- •Teeth with excessive bleeding from amputated radicular stumps
- •Teeth showing radiographic evidence of pathologic root resorption, inter-radicular bone loss, periapical pathology and calcifications in the canals.
- •Lack of patient/parent compliance and cooperation.
- •Children who are physically or mentally disabled or having any medical condition that will complicate the treatment
研究组 & 干预措施
A
干预措施: MTA group (Drug)
C
干预措施: Treated Dentin Matrix (Drug)
B
干预措施: Premixed Bioceramic material (Drug)
结局指标
主要结局
Clinical success
时间窗: 18 months
* Absence of pain related to the treated teeth, Including patient reported pain or sensitivity to percussion/palpation. * No evidence of swelling of supporting soft tissue or presence of sinus tract. * Absence of excessive mobility affecting treated teeth.
Radiographic success
时间窗: 18 months
* Radiographic criteria for success in terms of: * Progression of root formation * No Internal or external root resorption. * No Periapical or furcal radiolucency.
次要结局
未报告次要终点
研究者
Sarah Mohamed Fakhry
Principle Investigator
Ain Shams University