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
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- clinical outcomes
研究概览
简要总结
Assess tomographic outcomes of pulpotomy in young permanent molars using human-treated dentin matrix versus 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 pulpotomy procedure.The selected deeply carious molars were randomly divided into two groups as follows:
Group I (Study group): 20 molars were treated with hTDM. Group II:
(Control group): 20 molars were treated with White MTA. The participating cases were evaluated clinically 3, 6, 12 and 18 months. Digital periapical radiographs was taken at 6 month follow-up period to ensure the state of the treated teeth or if there was necessary condition.
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
drug: Human-treated dentin matrix young permanent molars treated with human-treated dentin matrix
干预措施: human treated dentin matrix (Drug)
mineral tri oxide aggregate
Drug: Mineral Trioxide Aggregate young permanent molars treated with Mineral Trioxide Aggregate mineral trioxide aggregate was used as control
干预措施: Mineral Tri-Oxide Aggregate (Drug)
结局指标
主要结局
clinical outcomes
时间窗: 18 months
Absence of pain related to the treated teeth, including pain or sensitivity to percussion/palpation, No evidence of swelling or presence of a sinus tract, Absence of mobility affecting the treated teeth
Tomographic outcomes
时间窗: 18 months
Continuous increase in root length and decrease in the apical diameter, Absence of radicular, interradicular and periradicular rarefaction, No loss of the lamina dura.
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