Comparative Evaluation of Partial and Complete Pulpotomy in Mature Permanent Molars With Clinical Signs Indicative of Irreversible Pulpitis
试验速览
- 阶段
- 不适用
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Clinical Success and radiographic success
研究概览
简要总结
This study will compare the outcome of partial pulpotomy and complete pulpotomy in mature permanent molars with clinical signs indicative of irreversible pulpitis
详细描述
After thorough history and clinical and radio graphic examination, and confirmation of eligibility for the study, written informed consent will be taken after explaining the procedure and its associated risks and benefits. Clinical diagnosis of irreversible pulpitis will be established based on a history of spontaneous pain or pain exacerbated by cold stimuli and lasting for a few seconds to several hours (lingering pain) compared to control teeth and which is reproducible using cold testing. Once included, study subjects will be randomly allocated to either Complete Pulpotomy group or Partial Pulpotomy group. (Mineral Trioxide Aggregate) MTA will be used as pulpotomy agent. A layer of resin modified Glass Ionomer liner will be placed over the MTA and tooth will be permanently restored with composite resin in second appointment.
Pain analysis will be carried out preoperatively and postoperatively at every 24 hours till 7 days after intervention. All the subjects will be followed up for evaluation of success at every 3 months from baseline to 1 year.
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 (Participant, 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
- •Inclusion criteria
- •The patient should be ≥18 years of age.
- •Restorable molar teeth.
- •Tooth should give positive response to pulp sensibility testing.
- •Clinical diagnosis of irreversible pulpitis.
- •Tooth with probing pocket depth and mobility are within normal limits.
- •No signs of pulpal necrosis including sinus tract or swelling.
- •Non-contributory medical history
排除标准
- •Teeth with immature roots.
- •No pulp exposure after caries excavation.
- •Bleeding could not be controlled in 6 minutes.
- •Insufficient bleeding after pulp exposure, the pulp is judged necrotic or partially necrotic.
结局指标
主要结局
Clinical Success and radiographic success
时间窗: Baseline to 12 Months
CLINICAL SUCCESS CRITERIA: Absence of spontaneous pain, discomfort, swelling, sinus tract or tenderness to palpation or percussion. RADIOGRAPHIC SUCCESS CRITERIA: No pathosis evident on the radiograph such as root resorption, furcal pathosis or new periapical pathosis. Periapical Index score 1 or 2 according to Orstavic et al. Evaluation of both clinical and radiographic outcome is must for analyzing the actual success of therapeutic technique. Number of participants fulfilling both clinical as well as radiographic success criteria will be considered in success category.
次要结局
- Pain analysis(Baseline to 7 days)