Is Biodentine, as Successful as, Mineral Trioxide Aggregate for Pulpotomy of Primary Molars? A Split Mouth Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 主要终点
- radiographic success
研究概览
简要总结
: A split-mouth controlled clinical trial was carried out on 21 healthy, three to seven years old children, with 42 pairs (84 molars) of contralateral mandibular primary molars indicated for pulpotomy. One paired tooth in one side was designated to Biodentine (Group 1) and the other side for MTA (Group 2) as a pulp medicament. All pulpotomized teeth were finally restored with stainless steel crowns. Subjects were monitored clinically and radiographically at one, three, six and 12 months.
详细描述
Study design:
The present study was a split-mouth controlled clinical trial.
Sample size:
A sample size of 21 patients with 42 pairs of molars (84 molars) was determined using online sample size calculator (Sealed envelope.com).
Subjects:
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
blinding
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No history of spontaneous pain
- •Absence of tenderness to percussion.
- •Absence of physiologic or pathologic tooth mobility.
- •No clinical evidence of pulpal inflammation or degeneration, such as history of swelling or presence of sinus tract.
- •Restorable teeth.
- •Absence of radiographic evidence of internal or external root resorption, pulpal calcification, or osseous disease (periapical or furcation infection).
排除标准
- •Evidence of necrosis after access cavity preparation.
- •Hemostasis could not be achieved within three min after direct contact with a wet cotton pellet, prior to material placement.
研究组 & 干预措施
Biodentine pulpotomy
Biodentine (Septodont, France) Pulpotomy for primary molars Clinical and radiographic evaluation Follow up at 1,3,6 and 12 months
干预措施: Biodentine (Other)
MTA pulpotomy
MTA (Angelus- Londrina, Brazil) Pulpotomy for primary molars . it is fine hydrophilic powder consisting of tricalcium silicate, tricalicum aluminate, tricalcium oxide, silicate oxide and bismuth oxide11.
It is currently being used in pulpotomy of primary molars with a high rate of success.
Clinical and radiographic evaluation. Follow up at 1,3,6 and 12 months
干预措施: MTA pulpotomy (Other)
结局指标
主要结局
radiographic success
时间窗: 1 year
syptom free
次要结局
未报告次要终点
研究者
Randa Youssef Abd Al Gawad
Associate Professor
Cairo University