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临床试验/NCT05619796
NCT05619796已完成不适用

Assessment of Clinical and Radiographic Efficiency of Manual and Pediatric Rotary File Systems in Primary Root Canal Preparation

Tanta University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年9月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Root canal preparation using Manual and Pediatric Rotary File Systems during pulpectomy of primary teeth

研究概览

简要总结

Manual files used for the pulpectomy of primary teeth have some disadvantages such as time wastage and the occurrence of iatrogenic errors compared to rotary systems.

Little studies have been done to clinically evaluate the Kedo-S Square & Fanta AF™ Baby rotary systems in relation to the quality of obturation, instrumentation time and postoperative pain in root canal preparation of primary molars using CBCT.

详细描述

Biomechanical preparation is one of the most important steps of primary teeth pulpectomy, which are primarily targeted during canal debridement . Conventionally, hand files were used for cleaning and shaping in primary teeth with some disadvantages such as time wastage and the occurrence of iatrogenic errors such as zipping, lateral perforations, apical obstruction, and canal transportation.

The use of rotary instruments for primary tooth instrumentation is faster, affordable, and yields consistent, reliable results. Numerous rotary endodontic systems designed primarily for application in permanent teeth, have been suggested for primary teeth root canal preparation. Since the primary teeth have a ribbon-shaped anatomy and shorter, thinner curved roots than permanent teeth, the use of these files in pulpectomy of primary teeth could produce lateral perforations. As a result, there was a great need for the development of a unique pediatric rotary file system.

The Kedo-S Square rotary system is a single file system specifically designed for paediatric use. It consists of two files, one for anterior primary teeth (A1) and one for posterior primary teeth (P1) also, Fanta AF™-Baby rotary system, another specifically generated paediatric rotary file, was produced using Ni-Ti controlled memory (CM)-Wire technology.

A good root canal treatment in primary teeth is dependent on the quality of biomechanical preparation, the type of obturating material used with as few voids as possible, and the achievement of a good hermetic seal. Also, treatment time is an important aspect as reduced chairside time increases children's cooperation for dental treatment, reduces anxiety, and making the treatment protocol optimal. Another factor affecting the success of primary teeth pulpectomy is the postoperative pain which may be due to extrusion of foreign particles into peri-radicular tissues accordingly, causing inflammation and releasing inflammatory mediators.

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)

盲法说明

the quality of root canal filling by two trained pediatric dentists, blinded to instrumentation technique.

A nursing officer who was blind to the study groups, had trained all parents on how to record the postoperative pain.

入排标准

年龄范围
4 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • healthy cooperative children
  • non-vital posterior teeth with sufficient coronal structure
  • intact 2/3rd root structure
  • no mobility or external pathological root resorption

排除标准

  • Uncooperative children
  • children with systemic illness
  • non-restorable primary molars
  • primary molars with sever mobility, or pathological root resorption

结局指标

主要结局

Root canal preparation using Manual and Pediatric Rotary File Systems during pulpectomy of primary teeth

时间窗: 2 days

by evaluation of the obturation quality using immediate post-operative CBCT which is assessed by two trained pediatric dentists, blinded to instrumentation technique . The quality of obturation was assessed by evaluating the length of the Metapex filling according to Coll and Sadrian criteria : * Under filling (Score 1): Canal filled with metapex more than 2 mm short of the apex. * Optimal filling (Score 2): Canal filling ending at the radiographic apex or up to 2 mm short of apex. * Overfilling (Score 3): Any canal showing filling outside the root apex.

次要结局

  • postoperative pain after primary teeth pulpectomy using Manual and Pediatric Rotary File Systems(2 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shaimaa Shaban Mohamed El-desouky

Lecturer of Pediatric dentistry

Tanta University

研究点 (2)

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