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临床试验/CTRI/2024/11/076924
CTRI/2024/11/076924招募中3 期

"Cormparative Eva!uation of Clinical Outcome, Radiographie Success and Antimicrobiat Efficacy of Hand Files With Reciprocating Handpiece V/s 3 Different Rotary File Systems in Primary Teeth: A Randomized Clinical Study".

Department of Pedodontics1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年12月4日最近更新:

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
The primary outcome is the success of the

研究概览

简要总结

Successful pulp therapy (SPT) requires

absolute aseptic condition of the root canals

by adequately cleaning and shaping of the

root canal.[1] Convoluted pulpal canals often

make the biomechanical preparation a

challenging process in primary teeth.[2] Ideal

obturation should provide fluid impervious

seal for the successful pulp therapy.[3] There

are numerous factors which are responsible

for achieving the ideal quality of obturation

such as, preparing the root canal walls to

achieve adequate filling of the obturating

material till the apex and the presence of

three- dimensional seal of the root canal.[4]

One of the main complications faced by

children following pulp therapy is the

presence of postoperative pain.[5]

Postoperative pain is due to the apical

extrusion of the debris during

instrumentation producing inflammatory

reaction. The biological objective is to

eliminate necrotic pulp, bacteria, and

bacterial toxins using instrumentation and

irrigation, followed by filling the sterile canal

with a resorbable material. [4] Besides

thorough cleaning and debridement of the

root canal, the treatment duration is

particularly important in pediatric dentistry.

The use of hand instruments is very time

consuming and produces unwanted

complications like apical transportation and

ledge formation.[7] Adequately tapered

preparations are required to seal the root

canals till the apex with the obturating

material.[8] To provide high-quality treatment

more efficiently, rotary instrumentation has

been introduced.[5] Rotary instrumentation

was introduced for primary teeth by Barr et

al. in 2000.[6] This technique offers both

advantages and disadvantages for primary

and permanent teeth. The use of rotary

systems facilitates uniform preparation and

thorough debridement of root canals. Silva et

al. reported that using rotary instrumentation

in primary teeth significantly reduces the

time required for root canal preparation.[7]

Studies have also demonstrated that nickeltitanium

(NiTi) rotary instruments provide a

good taper to the preparation, improving

obturation quality with minimal risk of canal

transportation.[8,9] However, Drukteinis and

Balciuniene noted that rotary instruments

might not completely clean the isthmus and

fins of primary teeth due to their centering

ability in the root canal. They recommended

additional use of an H-file to remove infected

tissue from ribbon-shaped canals and

mitigate this disadvantage.[10] Other

drawbacks of rotary instrumentation include

increased cost and the potential for

instrument breakage.[11]Exclusive rotary file

systems for primary teeth have been

developed over the time to overcome the

disadvantage of the existing rotary files like

Kedo s square File, Rainbow File, Fanta af

file etc. Hence,the aim of this clinical trial is

Comparative evaluation of Clinical

outcome, Radiographic success and

Antimicrobial efficacy of hand files with

reciprocating handpiece v/s 3 different types

of rotary file systems in primary teeth : A

randomized Clinical study

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
4.00 Year(s) 至 9.00 Year(s)(—)
性别
All

入选标准

  • Absence of periapical or interradicular radiolucency.
  • Radiographic absence of external or internal pathological resorption.
  • Primary teeth with at least 2/3 of the root intact.
  • Adequate tooth structure to support a rubber dam.
  • Children with Frankle + and++ Behaviour.

排除标准

  • Any subject that does not fall under the inclusion criteria were excluded Parents not willing to give consent Children with Special Health Care needs (SHCN) Children with systemic diseases.

结局指标

主要结局

The primary outcome is the success of the

时间窗: evaluation will be carried out at baseline, 3 months, 6 months and 12 months

treatment. Success will be defined by the

时间窗: evaluation will be carried out at baseline, 3 months, 6 months and 12 months

absence of major failure Clinically and Radiographically. i.e.

时间窗: evaluation will be carried out at baseline, 3 months, 6 months and 12 months

absence of pain, abscess, swelling, interfurcal radiolucency, root resorption etc. and patient and/or parent

时间窗: evaluation will be carried out at baseline, 3 months, 6 months and 12 months

acceptance will be clinically evaluated at

时间窗: evaluation will be carried out at baseline, 3 months, 6 months and 12 months

baseline and at last appointment

时间窗: evaluation will be carried out at baseline, 3 months, 6 months and 12 months

次要结局

  • The secondary outcome is the success of the(treatment)

研究者

发起方
Department of Pedodontics
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Amol Patil

Department of Pedodontics, M a Rangoonwala Dental College

研究点 (1)

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