Clinical, Radiographic and Tomographic Evaluation of Apexogenesis With Human Treated Dentin Matrix in Young Permanent Molars
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- clinical outcome
研究概览
简要总结
Assess the clinical, radiographic, and tomographic outcomes of apexogenesis with human treated dentin matrix in young permanent molars compared to MTA.
详细描述
The study was conducted as a split-mouth randomized clinical trial, approved by research ethics committee, Faculty of Dentistry, Tanta University, and carried out at Pediatric Dentistry Department, Faculty of Dentistry, Tanta University. The material preparation was conducted at Pharmaceutical Technology Department, Faculty of Pharmacy, Tanta University. 20 children of both sexes aged from 6 to 8 years old were selected with bilateral deeply carious young permanent mandibular first molars that are indicated for vital pulp therapy.The selected deeply carious molars were randomly divided into two groups as follows:
Group I (Study group): 20 molars were treated with human TDM. Group II: (Control group): 20 molars were treated with White MTA. The participating cases were evaluated clinically and radiographically after 6, 12 and 18 months. Tomographic evaluation was performed immediate postoperatively and at 18 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Bilateral immature permanent mandibular first molars with deep carious lesions.
- •Positive response to pulp testing.
- •Normal radiographic appearance.
- •Healthy children without any systemic disease that interferes with pulp healing.
- •Patient and parent cooperation.
排除标准
- •Clinical signs and symptoms of irreversible pulpitis as spontaneous throbbing pain, tenderness to percussion, abnormal tooth mobility, swelling, or sinus tract.
- •Presence of periapical lesion, external or internal root resorption.
- •Carious furcation involvement.
- •Dystrophic calcification of the pulp.
- •Non restorable tooth.
研究组 & 干预措施
human treated dentin matrix
study group
干预措施: human treated dentin matrix (Drug)
mineral tri oxide aggregate
control group
干预措施: Mineral Trioxide Aggregate (Drug)
结局指标
主要结局
clinical outcome
时间窗: 18 months
tooth mobility clinically assessed by grades
radiographic outcomes
时间窗: 18 months
peri-radicular changes assessed by clinician from digital periapical radiograph
tomographic evaluation
时间窗: 18 months
evidence of continuity of root development measured from cone beam computed tomography
次要结局
未报告次要终点
研究者
nora mostafa mohammed abo shanady
Assistant lecturer at pediatric dentistry oral health and preventive dentistry department
Tanta University