Outcome Following Use of NaOCl and Chlorhexidine as Wound Lavage Agents During Partial Pulpotomy in Mature Permanent Teeth With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Clinical Success and Radiographic Success
研究概览
简要总结
The goal of this clinical trial is to to compare effect of wound lavage agents NaOCl and Chlorhexidine on the outcome of partial pulpotomy in mature permanent posterior teeth with signs and symptoms indicative of irreversible pulpitis in.
The main question it aims to answer are:
Does wound lavage using chlorhexidine have equal effect as NaOCl on the outcome of partial pulpotomy in mature permanent mandibular posterior teeth with clinical signs of irreversible pulpitis?
Participants will of age group 18 to 45 years will be included and divided into two groups:
Pulp wound lavage in partial pulpotomy using 3% NaOCl as control and using 2% Chlorhexidine as experiment
详细描述
Title- Outcome following use of NaOCl and chlorhexidine as wound lavage agents during partial pulpotomy in mature permanent teeth with symptomatic irreversible pulpitis: A randomized clinical trial Research Question Does wound lavage using chlorhexidine have equal effect as NaOCl on the outcome of partial pulpotomy in mature permanent mandibular posterior teeth with clinical signs of irreversible pulpitis? PICO
- P (Population) - Mature permanent posterior teeth with clinical signs of symptomatic irreversible pulpitis
- I (Intervention) - 2% Chlorhexidine lavage during Partial pulpotomy
- C (Comparison) - 3% Sodium hypochlorite lavage during Partial pulpotomy
- O (Outcome) -Assessment of clinical and radiographic success at 12 months follow up To evaluate reduction in post operative pain experience at every 24 hours till 1 week
- T (time frame)- 18 months Aim-The aim of the study is to compare effect of wound lavage agents NaOCl and Chlorhexidine on the outcome of partial pulpotomy in mature permanent posterior teeth with signs and symptoms indicative of irreversible pulpitis.
Objective- Primary objective- To evaluate the clinical and radiographic success of partial pulpotomy using NaOCl or chlorhexidine as wound lavage agents in mature permanent posterior teeth with clinical signs and symptoms of irreversible pulpitis.
Secondary objective- To assess postoperative pain after partial pulpotomy using NaOCl or chlorhexidine wound lavage.
Setting: Dept. Of Conservative Dentistry & Endodontics, PGIDS, Rohtak. FINER F (feasible)= Adequate number of subjects for sample size and technical expertise are available to conduct the study I (Interesting)= The study aims to compare the effect of lavage agents (NaOCl and Chlorhexidine) on the outcome of partial pulpotomy in patients diagnosed with symptomatic irreversible pulpitis N(Novel)= No clinical trial study has compared the effect of wound lavage agents on the outcome of partial pulpotomy in mature permanent mandibular posterior teeth E(Ethical)= Ethical issues have been taken care of during the planning of the study. Subjects will be provided with information sheet and consent form. Once the study is approved by the ethical committee of the institution, it will be conducted and followed up R (Relevant)= This study will help formulate evidence-based guidelines for use of different lavage agents during partial pulpotomy in mature permanent mandibular posterior teeth.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mature permanent mandibular posterior teeth with extreme deep caries and clinical diagnosis of symptomatic irreversible pulpitis
- •Patients having normal periapical status with periapical index (PAI) score ≤ 2 and periodontally healthy teeth
- •Patients having physical status of class 1 or 2 according to ASA classification
- •Pulpal bleeding can be controlled within 10 minutes
排除标准
- •Necrotic pulp upon exposure
- •Presence of sinus tract or soft tissue swelling Pregnant patients Radiographic signs of internal or external root resorption
结局指标
主要结局
Clinical Success and Radiographic Success
时间窗: Base line 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
- Post operative pain(Base line to 7 days)