Clinical and Radiographic Success Following Regenerative Pulpotomy Using Chitosan Hydrogel Versus Platelet Rich Fibrin in Mature Mandibular Molars: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 主要终点
- Success Rate
研究概览
简要总结
The aim of this study is to assess the clinical and radiographic success and postoperative pain in mature mandibular molars following vital pulp therapy using chitosan hydrogel versus platelet rich fibrin.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients suffering from Symptomatic pulpitis in mature mandibular molars only will be involved.
- •Tooth should give positive response to cold test
- •Haemostasis should be achieved after full pulpotomy
- •The tooth is restorable and free from advanced periodontal disease, cracks and splits.
- •Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
- •Patients who will agree to the consent and will commit to follow-up period.
- •Patients with mature root apices
- •Patients with no internal or external resorption and no periapical lesions
- •Soft tissues around the tooth are normal with no swelling or sinus tract
排除标准
- •Patients with immature roots.
- •Haemostasias after 10 minutes cannot be controlled after full pulpotomy Patients with any systemic disease that may affect normal healing.
- •Patients with periapical lesions or infections.
- •Pregnant females.
- •Patients who could/would not participate in a 6 months follow-up.
- •Patients with fistula or swelling
- •Patients with necrotic pulp.
- •Patients with old age.
研究组 & 干预措施
Chitosan Hydrogel after full pulpotomy
Chitosan used as a medicament for pulpotomy as it is non-toxic biocompatible, bioadhesive, biodegradable, has wound healing ability and possesses antimicrobial activity. In addition, it encourages the odontogenic development of dental pulp stem cells.
干预措施: Full Pulpotomy (Procedure)
Platelet Rich Fibrin after full pulpotomy
Platelet-rich fibrin (PRF) is strictly autologous, biocompatible and kind toward pulp, and hence elicits minimal or nil inflammatory response when placed directly over the severed pulp.
干预措施: Full Pulpotomy (Procedure)
结局指标
主要结局
Success Rate
时间窗: 6 months (Postoperative)
Using Radiographic success criteria by periapical index (Orstavik et al., 1986)
次要结局
- Postoperative pain(1st day up to 7th day)
- Tooth sensibility(1,3,6 months (postoperative))
研究者
Perihan Adel Abdel Aziz Wafi
Resident at Faculty of Dentistry
Cairo University