Clinical and Radiographic Evaluation of 3Mixtatin Versus MTA Used as Pulpotomy Agents in Vital Primary Molars: A Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Clinical success Clinical success clinical success
研究概览
简要总结
The aim of the study is to evaluate clinical and radiographic success of using 3Mixtain versus mineral trioxide aggregate in pulpotomy of deeply carious Primary molars.
详细描述
Due to the complexity of the root canal microbiome, it is doubtful that they can be treated properly with a single antibiotic. Accordingly, a combination of multiple antibiotics seemed to be essential to diminish different types of pathogenic bacteria. Recently, a combination of three antibiotics (Metronidazole, cefixime, and Ciprofloxacin) along with Statins (new bio-inductive materials in regenerative dentistry) has shown promising results in primary teeth pulp therapy.
Statin components have an anti-inflammatory impact on pulp tissue by lowering the amount of interleukin-6 and interleukin-8. They also decrease osteoclastic processes and strengthen osteoblastic processes. Thus, they promote bone regeneration and dentin formation by enhancing odontoblastic activity. Several studies have shown a clinical and radiographic success rate of 3Mixtatin with inconsistent results. Some randomized controlled Trials (RCTs) showed that MTA had a comparable result with 3Mixtatin, while others reported that 3Mixtatin might be an alternative for MTA due to its higher overall success rate. 3Mixtatin is considered as a novel material with successful outcomes. Owing to limited availability of data in researches and in order to reach a conclusive results our study aims to evaluate clinical and radiographic success of using 3Mixtain versus mineral trioxide aggregate in pulpotomy of deeply carious Primary molars .
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
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Children 4-8 years old
- •Vital deeply carious primary molars.
- •No history of spontaneous pain, pathologic mobility, draining sinus tract, redness or swelling of the vestibule.
- •Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test.
- •Patient and parent showing cooperation and compliance.
排除标准
- •• Uncooperative children to avoid time waste and attrition bias.
- •Unrestorable molars
- •Sign of radiolucency in periapical or furcation area
- •Widening of PDL space or loss of lamina dura continuity
- •Evidence of internal/external pathologic root resorption
- •During operative procedure, when hemorrhage control is not achievable after pulpotomy.
- •Children with systemic disease as some systemic diseases may have effect on the outcome.
- •Unable to attend follow-up visits to avoid attrition bias by decreasing number of drop off cases.
- •Refusal of participation as the parent of child has the authority of participation.
研究组 & 干预措施
MTA pulpotomy
pulpotomy with MTA applied in the vital pulp therapy
干预措施: MTA pulpotomy (Drug)
3 Mixtatin pulpotomy
pulpotomy with 3 mixtatin (triple antibiotic paste of (Metronidazole, cefixime, and Ciprofloxacin mixed with simvastatin ) applied in the vital pulp therapy
干预措施: 3 mixtatin pulpotomy (Drug)
结局指标
主要结局
Clinical success Clinical success clinical success
时间窗: 1 week , 3 months , 6 months , 9 months and 12 months
absence of postoperative pain,Absence of pain on percussion,Absence of Swelling and Absence of Sinus or fistula
次要结局
- Radiographic success radiographic success(3 months , 6 months , 12 months)