Comparative Evaluation of Outcome Following Endodontic Treatment Using Traditional Versus Conservative Access in Mandibular Molars With Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Clinical and radiographic success
研究概览
简要总结
This study will compare the outcome of endodontic treatment using conservative or traditional access design in 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 obtained after explaining the procedure and its associated risks and benefits.
Clinical diagnosis of symptomatic 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 traditional access or conservative access group. Subsequently biomechanical preparation will be carried out using standard protocol with the use of rotary NiTi file system followed by root canal filling using gutta percha and zinc oxide eugenol sealer. Teeth will be restored using composite resin in the same 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 6 and 12 months from baseline.
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
- •The patient should be ≥18 years of age.
- •Restorable mandibular molars with extremely deep caries involving occlusal surface only
- •Clinical diagnosis of symptomatic irreversible pulpitis with PAI score ≤
- •Tooth should give positive response to pulp sensibility testing.
- •Tooth with probing pocket depth and mobility are within normal limits.
- •Non-contributory medical history.
排除标准
- •Teeth with immature roots.
- •No pulp exposure even after caries excavation.
- •Teeth with signs of pulpal necrosis including sinus tract or swelling.
- •Teeth with percussion sensitivity
- •Positive history of antibiotic use in the past 1 month or requiring antibiotic prophylaxis
- •Had taken analgesic in past 3 days
- •Teeth with pathologic changes such as internal or external resorption
- •Teeth with morphological variation
- •Teeth with root canal calcification
- •Teeth with fixed full coverage prosthesis
结局指标
主要结局
Clinical 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)