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临床试验/CTRI/2020/12/029470
CTRI/2020/12/029470已完成不适用

COMPARATIVE EVALUATION OF POST-OPERATIVE PAIN AFTER SINGLE SITTING PULPECTOMY USING HAND AND ROTARY INSTRUMENTATION IN PRIMARY MOLARS OF CHILDREN – A RANDOMISED CONTROL STUDY

Department of Pediatric and Preventive Dentistry1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Post operative pain

研究概览

简要总结

Primary teeth act as a natural space maintainer and guide theeruption of permanent teeth to their optimal position in the dental arch. Theretention and preservation of the primary tooth in the dental arch in itsnormal function and free of pathology is of utmost importance. Therefore, it isof prime importance as a Pediatric Dentist to maintain the integrity of tooth inthe dental arch till natural exfoliation takes place.1Paediatricdentistry is changing from surgical treatment planning to conserving primaryteeth till their natural exfoliation occurs for proper occlusal guidance andalso aid in mastication. Restoration is carried out in carious teeth involvingenamel and dentine and pulp therapy in those which are showing pulpal andperi-radicular involvement.2

Pulpectomyprocedure consists of various steps out of which absolute chemo-mechanicalpreparation of the root canal system is a requisite for a successful endodontictreatment.  Studies have shown higherfrequency of post-endodontic pain following multiple visits as compared tosingle-visit endodontic treatments.3

Conventionally,manual K-files have proven to be a gold standard providing excellent tactile control and sharp,long-lasting cutting surfaces. Despite the widespread use of manualinstrumentation for pulpectomy in primary teeth, there is incidence ofpost-operative pain due to linear filing motion.2The post-endodontic pain may be caused due to ongoing inflammatoryprocesses or changes in the periapical tissue pressure post instrumentation.4

Although, K-fileshave aided in the pediatric endodontic treatment since ages and provedsuccessful yet there is a need felt to introduce a newer filing system toreduce the incidence of post endodontic pain.5Rotary instrumentswere introduced to Paediatric dentistry by Barr et al in 2000.With thedevelopment of nickel–titanium (NiTi) rotary shaping systems in the recentpast, a reduction in the timing and increased clinical efficacy has been seen.5

The NiTi alloyproves more effective for cleaning the tortuous and irregular canal walls ofthe primary teeth due to, Greaterelasticity, Central canal preparation, Less apicaltransportation, Use of lesser number of files. Hence it marks a far betterchoice for Paediatric endodontic procedures in the upcoming era. 6

            Whenliterature search was carried out in last three months, there were no studiesconducted in Indian scenario and worldwide regarding post- operative pain usingHand Files and Rotary Files after Single Sitting Pulpectomy. So, an attempt ismade to carry out this research to evaluate and compare   the post-operative pain using Hand Files andRotary Files After Single Sitting Pulpectomy.

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.Children with Frankl’s behaviour rating scale of positive (+) and definitely positive (++).
  • •3.Tooth with the history of spontaneous pain.
  • •4.Radiographic evaluation of the tooth showing irreversible pulpitis.
  • •5.Primary molars with minimum two third of the root length.
  • •6.Patients who are willing to undergo treatment.

排除标准

  • •1.Children with systemic diseases and special health care needs.
  • •2.Non-vital teeth having signs of abscess, sinus and fistula.
  • •3.Primary molars with pathologic mobility and evidence of root fracture, trauma.
  • •4.Primary molars having furcation radiolucency.
  • •5.Primary molars with calcified root canals.
  • •6.Primary molars with more than two third root resorption, internal resorption and developmental anomalies.
  • •7.Patients who are not willing to undergo treatment.

结局指标

主要结局

Post operative pain

时间窗: 24 hours | 48 hours | 72 hours

次要结局

  • Reduction in pain, swelling and increasing the quality of life(After 24hours, 48 hours, 72hours)

研究者

发起方
Department of Pediatric and Preventive Dentistry
申办方类型
Research institution and hospital

研究点 (1)

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