Clinical effectiveness of Concentrated Growth Factor and injectable bioceramic material compared to MTA as pulpotomy agent in Permanent Mature Molar with Symptomatic Irreversible Pulpitis- a randomized controlled clinical trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Post operative pain , tenderness and swelling (yes or no)
研究概览
简要总结
Background and Rationale:
The traditional treatment modality for permanent mature teeth diagnosed with irreversible pulpitis is pulpectomy, also known as nonsurgical root canal treatment (NSRCT)(Santos et al. 2021).However this reduces the survival time of the tooth(Caplan et al. 2005). Pulpotomy has been proposed as an alternative for management of irreversible pulpitis in permanent teeth with closed apices (Alqaderi et al. 2016).Choice of pulpotomy agent is an important decision factor which has an influence on the success rate of the treatment . Concentrated Growth Factor and injectable bioceramic material iRoot Bp will be compared with MTA as pulpotomy agent .
Materials and methods:
Population: Patients who have permanent mature molar with symptomatic Irreversible Pulpitis
Intervention: CGF, iRootBP
Comparison: MTA
Outcome:
Group A: MTA
Group B: CGF
Group C: iRootBp
Primary outcome: Post operative pain, tenderness and swelling (yes or no)
Secondary outcome: Presence of periapical lesions at 3, 6 & 12 months recall. Dentin bridge formation at 12 months interval through CBCT radiographic analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with symptomatic Irreversible Pulpitis of age 18 to 40 years permanent mature molar teeth with symptomatic irreversible pulpitis 2)Both Maxillary and Mandibular molar teeth.
- •A clinical diagnosis consistent with irreversible pulpitis will be established in all cases based on a history of severe spontaneous lingering pain that could be reproduced by cold testing.
- •Teeth which are tender to percussion can be included but those with periapical lesions, resorption of root must be excluded.
排除标准
- •Patients < 18years of age.
- •Patients of age > 40 years of age 3)Medically compromised patients 4)Pregnant and lactating women.
- •Patients undergoing fixed orthodontic therapy 6)Patients with facial deformity including cleft lip/palate.
- •Teeth with apical periodontitis.
- •Teeth with fracture or crack lines.
- •Teeth with abrasion on the same tooth.
结局指标
主要结局
Post operative pain , tenderness and swelling (yes or no)
时间窗: Post operative pain will be assessed after 24 hours and 48 hours, tenderness and swelling (yes or no)will be checked after 48 hours and 3 months | Pain will be assessed using Visual Analog Scale (VAS)
Pain will be assessed using Visual Analog Scale (VAS)
时间窗: Post operative pain will be assessed after 24 hours and 48 hours, tenderness and swelling (yes or no)will be checked after 48 hours and 3 months | Pain will be assessed using Visual Analog Scale (VAS)
次要结局
- Presence of periapical lesions at 3, 6 & 12 months recall. Dentin bridge formation at 12 months interval through CBCT radiographic analysis.