Evaluation of the Effect of Different Calcium Silicate Cements on the Success of Vital Pulp Therapy in Irreversible Pulpal Infection Cases With Mature Roots: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Postoperative pain
研究概览
简要总结
This randomized controlled clinical trial aims to evaluate the effect of two calcium silicate cements-Biodentine and EndoCem-on post-operative pain and treatment success in vital pulp therapy (VPT) for mature permanent mandibular molars diagnosed with irreversible pulpitis. A total of 50 patients will be randomly assigned into two groups to receive pulpotomy using either Biodentine or EndoCem. The trial is triple-blinded, self-funded, and conducted at the Endodontic Department, Faculty of Dentistry, The British University in Egypt.
详细描述
This randomized controlled clinical trial investigates the impact of Biodentine and EndoCem on post-operative pain and treatment success in vital pulp therapy (VPT) of mature permanent mandibular molars with symptomatic irreversible pulpitis.
VPT preserves the vitality of radicular pulp by removing inflamed coronal pulp tissue and capping the remaining healthy pulp with a biocompatible material. This conservative approach may maintain pulp vitality, reduce treatment time, and improve patient outcomes compared to conventional root canal treatment.
Fifty eligible patients will be randomly assigned into two groups (n=25 per group). Pulpotomy will be performed under rubber dam isolation. After caries removal and coronal pulp amputation, hemostasis will be attempted with sterile saline-soaked cotton pellets. If bleeding persists beyond 5 minutes, the tooth will be excluded. The remaining pulp tissue will be capped with either Biodentine (Group 1) or EndoCem (Group 2), followed by immediate permanent restoration with composite resin to ensure a coronal seal.
Eligibility Criteria
Inclusion Criteria:
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Patient's age ranges from 12-40 years old.
- •Two Rooted Mandibular Molar teeth diagnosed with symptomatic irreversible pulpitis
- •The teeth are restorable
- •Informed consent granted
- •Teeth are periodontally free, with no mobility and negative to percussion and palpation test.
排除标准
- •Teeth with immature roots
- •Non restorable teeth
- •Bleeding could not be controlled after pulpotomy in 10 minutes
- •Medically compromised patients with systemic complication that would alter the treatment.
- •Necrotic teeth
- •Inability to give informed consent
结局指标
主要结局
Postoperative pain
时间窗: Time Frame: at 6 hours, 24 hours, 48 hours, and 72 hours after treatment
Pain intensity measured using the Visual Analogue Scale (VAS), a 100 mm scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate worse pain
次要结局
- Success Rate(follow up at 3 and 6 months)
研究者
Yassmin
Yasmeen El-shaarawi, BDS, MSc Candidate, Principal Investigator
British University In Egypt