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临床试验/NCT03684915
NCT03684915Unknown不适用

Clinical Post-operative Assessment of Chronic Signs & Symptoms Related to Infected Primary Molars After Using Rotary Versus Manual Systems in Cleaning the Root Canals: A Randomized Clinical Trial

Cairo University0 个研究点目标入组 50 人开始时间: 2018年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
50
主要终点
Resolution of fistula

研究概览

简要总结

One of the most important concerns in pediatric dentistry is the loss of necrotic primary molars leading to space loss. pulpectomies for primary teeth with severe pulpal involvement should be considered as the treatment of choice.

Bacteria plays an essential role in the initiation and perpetuation of pulpal and periapical disease. The investigator's target when cleaning and shaping the root canal system is to remove bacteria-containing tissue.

The removal of organic debris is the main purpose of instrumentation in pulpectomy procedures in primary teeth, this could be achieved using manual or rotary Ni-Ti files. A practical pulpectomy technique for the primary teeth should include the following:1) Fast procedure with short treatment time and minimal number of appointments.2) Effective debridement of the root canal without weakening the tooth structure or endangering the underlining permanent teeth.3) Minimal procedural complications. 4) Maintaining tooth function until it is naturally exfoliated.

Manufacturers using rotary files highlight their cleaning efficiency for root canal preparations, simple procedures, and decreased procedure time, which is especially important in children.

Considering that preparation time is an important clinical factor in pediatric patient management, the use of rotary instruments for pulpectomies in primary teeth is recommended.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
4 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • primary molars with fistula / chronic abscess
  • teeth which if lost possibility of space maintainer construction exists
  • pre-operative radiograph showing absence of severe root resorption

排除标准

  • teeth with non-restorable crowns
  • expected shedding time within one year

研究组 & 干预措施

rotary files

Experimental
  1. Pre-operative radiograph showing all roots and their apices.
  2. Local anaesthetic (to enable use of rubber dam clamp).
  3. Rubber dam isolation.
  4. Removal of caries.
  5. Removal of roof of pulp chamber.
  6. Removal of any remains of coronal pulp tissue with sharp sterile excavator or large bur in slow hand piece.
  7. Identify root canals.
  8. Irrigate with normal saline (0.9%)
  9. Estimate working lengths of root canals keeping 2 mm short of the radiographic apex.
  10. Insert rotary files into canals and debride the canals lightly and gently.
  11. Irrigate the root canals.
  12. Dry canals with pre-measured paper points, keeping 2 mm from root apices.
  13. Canals will be dried with paper points, obturated by injecting Metapex. (Meta Biomed - Metapex Root Canal Filling Material)
  14. Stainless steel crown will be performed

干预措施: Rotary files (Device)

manual files

Active Comparator

All steps as that of intervention group are to be followed except step (j) instead of it; a manual files will be inserted into the canals for debridement lightly and gently

干预措施: Rotary files (Device)

结局指标

主要结局

Resolution of fistula

时间窗: 3 months

unit of measurement: Yes/No using visual examination

次要结局

  • assessment of tooth mobility(3 months)

研究者

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

Basma Mohamed Zakaria Ahmed Zain

Principal investigator (Master Degree Student)

Cairo University

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