Clinical and Radiographic Evaluation of Apexogenesis Using Calcium Hydroxide Pulpotomy Versus Calcium Silicate-Based Material (Biodentine™) Pulpotomy in Cariously Exposed Vital Immature Permanent First Molars: A Randomized Controlled Trial With 12 Months Follow Up
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 38
- 主要终点
- Assessment of pain severity
研究概览
简要总结
This study aimed to evaluate the clinical and radiographic success of pulpotomy in cariously exposed vital immature first permanent molars using calcium hydroxide and calcium silicate-based material (Biodentine ™). After a 12 months postoperative period, Biodentine ™ proved very useful as a successful pulpotomy agent in young permanent teeth.
详细描述
Objective
This study aimed to evaluate the clinical and radiographic success of pulpotomy in cariously exposed vital immature first permanent molars using calcium hydroxide and calcium silicate-based material (Biodentine ™).
Participants and methods:
This study was carried out on patients attending an outpatient clinic in Pediatric Dentistry and Dental Public Health Department - Faculty of Dentistry - Cairo University - Egypt. A total of thirty-five patients had thirty-eight vital immature first permanent molar with deep caries, who satisfied the eligibility criteria and completed the follow-up period. Their age ranged between six years to nine years old with a mean age of 7.5+/-1 years. All teeth were mandibular. In this study, pulpotomy was performed to preserve the vitality and function of the remaining radicular pulp tissue, followed by applying one of the investigated pulp capping materials.
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, Care Provider, Outcomes Assessor)
盲法说明
Triple blinded (patient, radiographic assessors of results and statistician)
入排标准
- 年龄范围
- 6 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medical history: Healthy children with no physical or mental disorders assured through medical history questioning.
- •Mandibular vital immature first permanent molar with deep caries. Restorable. No clinical evidence of extensive pulp degeneration or periapical pathology.No radiographic evidence of periapical pathosis or interradicular bone loss, internal/external resorption and pulp calcification.
排除标准
- •Patients refuse to cooperate.
- •Spontaneous pain or severe pain which doesn't stop with analgesics.
- •Hemorrhage control wasn't achievable at the operative procedures
结局指标
主要结局
Assessment of pain severity
时间窗: 12 months
ordinal outcome measured with direct questioning to the patient using Verbal Rating Scale ( VRS)
Absences of swelling / fistulous tract
时间窗: 12 months
binary outcome observed clinically
次要结局
- Root maturation(12 months)
- Absence of tenderness to percussion(12 months)
- Absence of internal or external root resorption(12 months)
研究者
Shereen H Elshamy
assistant lecturer
Cairo University