Clinical and Radiographic Evaluation of Pulpotomy Using Calcium-Enriched Mixture Versus Pulpectomy Using Calcium Hydroxide/Iodoform Paste for the Treatment of Primary Molars With Irreversible Pulpitis: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Postoperative Pain Intensity
研究概览
简要总结
Will Calcium-Enriched Mixture (CEM) cement pulpotomy have less postoperative pain and more clinical and radiographic success compared to Calcium Hydroxide/Iodoform (Metapex) pulpectomy when managing second primary molars with irreversible pulpitis?
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)
盲法说明
statistician
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
- •Children:
- •Aged 6-8 years of both sexes. Cooperative and medically free. Diagnosed with irreversible pulpitis based on clinical and radiographic criteria.
- •Parents/legal guardians provide written informed consent. Parents able to attend follow-up visits.
- •Deep carious second primary molars with signs of irreversible pulpitis. No clinical signs of necrosis (abscess, fistula, mobility). No radiographic signs of necrosis (periapical lesion or resorption).
排除标准
- •Children:
- •With systemic or mental disorders. Whose parents refuse to give consent. Uncooperative behavior.
- •Signs of pulpal necrosis (swelling, fistula, pathological mobility). Periapical or furcal radiolucency exceeding half the furcation-apical distance. Non-restorable teeth, root caries, internal/external resorption, or calcified canals.
研究组 & 干预措施
pulpectomy group
Children in this group will undergo pulpectomy of second primary molars diagnosed with irreversible pulpitis using Calcium Hydroxide/Iodoform paste (Metapex). The procedure includes complete removal of the pulp tissue, canal instrumentation and irrigation, obturation with Metapex, and final restoration with glass ionomer cement followed by stainless steel crown.
干预措施: Pulpectomy using Calcium Hydroxide/Iodoform Paste (Metapex) (Procedure)
Pulpotomy Group
Children in this group will undergo pulpotomy of second primary molars diagnosed with irreversible pulpitis using Calcium-Enriched Mixture (CEM) cement. The procedure includes coronal pulp removal, hemostasis, placement of CEM cement as a base over the pulp tissue, and final restoration with glass ionomer cement followed by stainless steel crown.
干预措施: Pulpotomy using Calcium-Enriched Mixture (CEM) Cement (Procedure)
结局指标
主要结局
Postoperative Pain Intensity
时间窗: 1, 3, 6, 9, and 12 months post-treatment
Pain intensity will be evaluated using the Visual Analog Scale (VAS) of faces, rated from 0 (no pain) to 5 (severe pain). Assessment will be performed at 1, 3, 6, 9, and 12 months after treatment. Clinical success will be considered when the patient reports no pain (score = 0).
次要结局
- Evaluation of Clinical Success(1, 3, 6, 9, and 12 months post-treatment)
- Evaluation of Radiographic Success(6 and 12 months post-treatment)
研究者
Alaa Hassab Elrasoul Abdelmagid Mohamed
Principle investigator
Cairo University