A Comparative evaluation of treatment outcomes of coronal pulpotomy using biodentine alone versus combination of PRF & biodentine in mature permanent mandibular molars diagnosed with 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
- 30
- 试验地点
- 1
- 主要终点
- on percussion, mobility.
研究概览
简要总结
The purpose of this binary, non-inferiority randomized clinical controlled trial is to compare the long-term success of coronal pulpotomies in human permanent molars with irreversible pulpitis using Biodentine alone versus those performed with Biodentine and PRF. The clinical/radiographic outcomes of these cases will be evaluated at regular follow-up periods. In this binary non-inferiority randomized clinical controlled trial, treated teeth will be considered successful if there are absence of clinical symptoms and no evidence of internal or external root resorption or any further treatment (i.e., extraction due to pathology or pulpectomy) is necessary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 14.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Peri-apical widening (mild)may or msy not be present
- •Sensitivity to hot and cold
- •Acute pain
- •Tenderness on percussion may or may not be present
- •Mandibular first and second permanent molar
- •Limited carious extent that does not require prosthetic treatment.
排除标准
- •Periapical lesion
- •Excessive coronal damage due to caries
- •Pregnancy
- •Chronic Lesion
- •History of pain, long back
- •Presence of swelling
- •Presence of mobility
- •Periodontal involvement ( presence of pocket).
结局指标
主要结局
on percussion, mobility.
时间窗: Follow up of 1, 3, 6 months will be taken
• Radiographic Assessment- Absence of evident pathosis, example, root
时间窗: Follow up of 1, 3, 6 months will be taken
• Clinical Evaluation - Absence of symptomatology that is, pain, swelling, tender
时间窗: Follow up of 1, 3, 6 months will be taken
widening.
时间窗: Follow up of 1, 3, 6 months will be taken
resorption furcal pathosis, new periapical lesion and/or resolution of apical
时间窗: Follow up of 1, 3, 6 months will be taken
• Pulp Sensibility Testing-Positive EPT response (higher threshold values than
时间窗: Follow up of 1, 3, 6 months will be taken
baseline values)
时间窗: Follow up of 1, 3, 6 months will be taken
次要结局
- • Clinical Evaluation - Absence of symptomatology that is, pain, swelling, tender(on percussion, mobility.)