FULL PULPOTOMY USING TWO BIOACTIVE MATERIALS IN MATURE PERMANENT TEETH DIAGNOSED WITH SYMPTOMATIC IRREVERSIBLE PULPITIS: A RANDOMIZED CLINICAL TRIAL”
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Primary objective will be to evaluate the effectiveness of two materials as pulpotomy agents in mature permanent teeth and compare the success rate of these materials in terms of clinical and radiographic evaluation at 12 month follow up.
研究概览
简要总结
This is a randomized, doble blind, parallel group prospective study in which we are comparing the efficacy of two pulpotomy materials i.e. TheraCal PT and MTA PUTTY for mature permanent teeth diagnosed with symptomatic irreversible pulpitis.
Pain assessment will be done in recall examination at 24-hour, 48-hour and1 week postoperatively after initial appointment by using heft parker scale.
If patient comes with pain after 7 days, then that case will be considered as an immediate failure in the study.
Routine clinical and radiographic examination will be done at 3 months, 6 months and 12 months.
Data will be statistically analysed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Teeth with symptomatic irreversible pulpitis with (spontaneous, lingering pain response to cold or electric pulp testing, nocturnal pain that can be mild to moderate.) 2.Medically healthy patients range between 18- 65 years of age 3.Restorable tooth with probing pocket depth and mobility within normal limits.
- •4.Extremely deep caries extending to pulp chamber 5.Patients who agree to written informed consent 6.Periapical index PAI score 1.
排除标准
- •1.Immature teeth 2.Teeth with apical resorption 3.No signs and symptoms of irreversible pulpitis 4.Non restorable teeth 5.Uncontrollable bleeding following pulpotomy lasting more than 10 min.
- •6.Insufficient bleeding due to necrosis 7.Presence of sinus tract or swelling 8.Allergy to local anesthetic 9.Patients on analgesics, anti-inflammatory drugs & antibiotics 10.PAI score >1.
结局指标
主要结局
Primary objective will be to evaluate the effectiveness of two materials as pulpotomy agents in mature permanent teeth and compare the success rate of these materials in terms of clinical and radiographic evaluation at 12 month follow up.
时间窗: 12 months
次要结局
- Secondary objective will be to evaluate reduction of preoperative pain after pulpotomy & whether any difference observed between the materials tested.(12 months)
研究者
Ambika Bhardwaj
BHOJIA DENTAL COLLEGE AND HOSPITAL