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临床试验/NCT06142799
NCT06142799招募中不适用

Post-treatment Pain After Cementing an Indirect Restoration at the End of a Root Canal Treatment: Clinical Trial

Universitat Internacional de Catalunya4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年11月14日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
4
主要终点
postoperative pain

研究概览

简要总结

The goal of this randomized clinical trial is to compare immediate placement of an overlay after root canal treatment with delayed placement of the overlay leaving the tooth one week in infra occlusion. The main question it aims to answer are:

type of study: clinical trial participant population/health conditions: patients more that 18 years old who need a root canal treatment in posterior teeth with antagonist teeth.

question 1: postoperative pain after 6 hours question 2: postoperative pain after 12 hours question 3: postoperative pain after 24 hours question 4: postoperative pain after 48 hours question 4: postoperative pain after 72 hours

If there is a comparison group: Researchers will compare immediate overlay placement and delayed (1 week) overlay placement after root canal treatment to see if there is more pain in one group than in the other.

详细描述

Introduction: International consensuses on restoration of the root filled teeth recommend early placement of indirect cuspal coverage in posterior teeth. Some classical schools of thought have argued that after endodontic treatment there may be slight periapical inflammation that may lead to over-occlusion, this causing postoperative pain, so that it is preferable to leave the tooth in slight under-occlusion and defer the definitive restoration. Recent studies question this theory and propose a restoration with normal occlusion at the same time of root canal treatment, if possible. Even in these cases, the placement of a full coverage indirect restoration is postponed due to the material impossibility of fabricating it with traditional systems. Modern computer assisted design (CAD)/ computer assisted manufacture (CAM) dental systems make it possible to produce and place such restorations in the same session as the endodontic work is completed. This greatly reduces chair time and the number of visits, while increasing the strength of the tooth right from the start. This is why in this study we compare postoperative pain in two groups of endodontically treated teeth, one in which the indirect CAD/CAM restoration is performed on the same day as the endodontic treatment, and the other in which it is postponed for a week, leaving the tooth in underocclusion.

Background and current status of the subject:

The main reason for root filled teeth loss is restorative failure, which accounts for 60% of all failures. This is followed in order of frequency by periodontal failure, which accounts for 30% of the total. Purely endodontic failure accounts for only 10% of all failures. On the other hand, we know about the high success rate and even higher survival rate of endodontically treated teeth. In a follow-up study of 1462936 endodontic procedures, an 8-year survival rate of 97% was observed. It is accepted that the success, a more demanding criterion than survival, of these root canals ranges between 85 and 90%. Given that most failures occur in the first two years, and given, as already mentioned, that the main cause of this failure is inadequate reconstruction, it has been advised to proceed to definitive restoration of the tooth with an indirect veneering material, and as early as possible.

Modern CAD/CAM systems, and especially the CEREC system, make it possible to produce high-quality chairside indirect restorations in a short time. This makes it possible to place the indirect restoration in a single session. With an appropriate strategy, it is possible to make impressions of the restoration before the root canal treatment is completed. Thus, while the treatment is being completed, the restoration can be fabricated and immediately placed in the tooth without removing the rubber dam isolation at the same visit as the root canal treatment is completed.

After root canal treatment it is possible that periapical inflammation may occur, leading to some overeruption of the tooth. It has been said that this can be a cause of postoperative pain. Thus, there are authors who question the performance of the definitive full-volume restoration on the same day of endodontics, preferring to leave the tooth with a provisional restoration in infraocclusion. However, the literature is not clear regarding a possible increase in postoperative pain in the case of leaving a definitive restoration at full volume, while questioning the relationship between postoperative pain and the type of restoration on the day of endodontics.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Need of a root canal treatment in a posterior tooth

排除标准

  • Preoperative pain requiring pain killers
  • Absence of antagonist teeth
  • cannot afford and overlay

结局指标

主要结局

postoperative pain

时间窗: 6, 12, 24, 48, 72 hours

Pain assessed by the visual analog scale. A 10 cm line with the words "extreme pain" and "no pain" will be used

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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