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临床试验/CTRI/2025/03/083116
CTRI/2025/03/083116尚未招募不适用

Comparative Evaluation Of Instrumentation Time, Quality Of Obturation And Postoperative Pain Using Two Different Single File Systems In Root Canal Preparation Of Primary Mandibular Molars: A Split Mouth Randomized Trial

ITS Dental College Hospital and Research Centre Greater Noida1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2025年1月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
46
试验地点
1
主要终点
Instrumentation Time will be recorded using a stopwatch, Post operative radiograph to assess the quality of obturation will be done Using KEDOO Classification

研究概览

简要总结

Dental caries involving the pulp leads to irreversible pulpal inflammation, abscess formation or pulpal necrosis. In such cases Pulpectomy is the treatment of choice. This procedure addresses the issue by removing the infected pulp, followed by cleaning, shaping and drying the root canals and then filling them with a biocompatible material. Hand files are conventionally used for chemo-mechanical preparation during pulpectomy procedures. However, their use can be challenging in the narrow and curved canals of primary teeth that are undergoing physiological resorption, which may result in difficulty to achieve proper filling of the canals and also prolong the treatment duration. Patient cooperation is crucial for the success of paediatric endodontic treatment, as longer procedures can increase anxiety and uncooperative behaviour, negatively affecting treatment quality. Postoperative pain and swelling are common complications of pulpectomy, often caused by apical extrusion of obturating material. To address these challenges, NiTi rotary technique for primary teeth was introduced. Reciprocating movement for canal shaping and debridement has gained popularity in paediatric dentistry due to its improved speed, safety, and fewer errors compared to continuous rotation systems. The Kedo Nano Plus Rotary single file system, features a nanoparticle coating which offers enhanced flexibility and better resistance to torsional forces in curved canals, reducing the risk of file fractures. The newly introduced KEDOO classification divides mandibular molar canals into mesial and distal sections with each canal being assessed individually. Therefore this research aims to evaluate the efficiency of using Kedo Nano Plus rotary single file system and WaveOne Gold reciprocating single file system in root canal preparation of primary mandibular molars in the terms of Instrumentation time, Quality of obturation and postoperative pain.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
4.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • 1- Children in the age group of 4- 8 years 2- Bilateral Involvement of Primary mandibular molars with irreversible pulpitis 3- Teeth with 2/3rd Root length remaining 4- Children free from systemic disease 5- Children with Frankel behaviour rating of 3 and 4 6- Patients who give consent to participate in the research.

排除标准

  • 1- Teeth close to exfoliation 2- Teeth with mobility 3- Patient present with Extraoral Swelling and Cellulitis 4- Children with special health care needs 5- Teeth with unrestorable crown structure.

结局指标

主要结局

Instrumentation Time will be recorded using a stopwatch, Post operative radiograph to assess the quality of obturation will be done Using KEDOO Classification

时间窗: At Baseline

次要结局

  • Postoperative Pain Will be checked using the Wong Baker FACES Pain Rating Scale after the Root Canal Treatment in Primary Mandibular Molars has been completed(6 Hours, 24 Hours & 72 Hours)

研究者

发起方
ITS Dental College Hospital and Research Centre Greater Noida
申办方类型
Research institution and hospital

研究点 (1)

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