Regenerative Potentials of Mature Mandibular First Molars With Symptomatic Irreversible Pulpitis Enhanced With Different Scaffolds: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Intensity of postoperative pain
研究概览
简要总结
The current study aims to assess the influence of different scaffolds on postoperative pain and success rate of pulpotomy in mandibular mature molars with symptomatic irreversible pulpitis
详细描述
The study aims to assess different scaffolds used in regenerative pulpotomy of mature permanent mandibular first molars diagnosed with symptomatic irreversible pulpitis and their influence on postoperative pain and clinical and radiographic success rate of pulpotomy. It also aims to correlate the level of inflammatory mediators in pulpal blood to the success rate of pulpotomy.
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
- 15 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I patients who are free from any physical or mental handicapping condition with no underlying systemic disease.
- •Age between 15-40 years.
- •Males & Females.
- •Patients' acceptance to participate in the trial.
- •Patients who can understand pain scale and can sign the informed consent (Appendix I).
- •Mature mandibular fist molars:
- •Diagnosed clinically with symptomatic irreversible pulpitis and normal periapical tissue.
- •Giving a positive response to pulp sensitivity testing.
- •Having negative response to percussion.
- •Having normal radiographic appearance of periapical tissues.
- •Having bright red color of pulp tissue, with hemorrhage control within 10 mins, upon access cavity preparation.
排除标准
- •Pregnant and lactating females.
- •Patients with physical or mental handicapping conditions.
- •Patients unwilling to participate in a 12-months follow up.
- •Mandibular first molars with:
- •Immature roots.
- •Negative response to pulp sensitivity testing.
- •Positive response to percussion.
- •Radiographic evidence of periapical lesions, external or internal root resorption, vertical root fracture, or calcification.
- •Intraoral swelling or fistula.
- •Lack of pulpal bleeding, or inability to achieve hemostasis of the bleeding pulp within 10 mins, upon access cavity preparation.
研究组 & 干预措施
PRF scaffold
干预措施: Regenerative pulpotomy (Procedure)
Ascorbic acid augmented PRF scaffold
干预措施: Regenerative pulpotomy (Procedure)
Tannic acid cross linked PRF scaffold
干预措施: Regenerative pulpotomy (Procedure)
结局指标
主要结局
Intensity of postoperative pain
时间窗: 6, 12, 24, and 72 hours postoperatively
measured using numerical rating scale
次要结局
- IL-8 and TNF-α levels in pulpal blood(Upon access cavity preparation)
- Overall success rate(1, 3, 6, 9 and 12 months postoperatively.)
研究者
Omnia Abdel Hakim
Assistant lecturer
Cairo University