"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".
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
Amol Patil
Department of Pedodontics, M a Rangoonwala Dental College
