跳至主要内容
临床试验/NCT06515756
NCT06515756已完成不适用

The Effect of Three Different Bioceramic-Based Root Canal Sealers on Post-Operative Pain

Kırıkkale University3 个研究点 分布在 2 个国家目标入组 120 人开始时间: 2023年7月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
3
主要终点
Change in pain from 6 th hours to 30 days between root canal sealers

研究概览

简要总结

Brief Summary: The purpose of this study was to evaluate the effect of MTA-Bioseal, GuttaFlow bioseal, and NeoSealer Flo calcium-silicate based root canal sealers on postobturation pain in teeth with asymptomatic irreversible pulpitis or chronic apical periodontitis undergoing single-visit root canal treatment.

The study tried to answer whether the type of sealer used altered the incidence and intensity of postobturation endodontic pain, whether pulp status affected the incidence and intensity of postobturation endodontic pain and whether there was no difference in analgesic intake by patients after a single-visit root canal treatment between the experimental groups.

详细描述

This prospective clinical study was reported pain levels experienced after obturation were similar for the different pulp statuses and root canal sealers tested. The participants with single-rooted teeth were included and divided into four groups according to the root canal sealer used. Then, the patients were divided into two subgroups according to pulp vitality. The postobturation pain scores were recorded after obturation on a visual analog scale (VAS) at 6, 12, 24, and 48 hours, and at 7 and 30 days. The level of pain experienced after obturation was similar for all root canal sealers in different pulp statuses. The results of the study showed that the bioceramic-based sealers tested can be used safely in clinical practice in terms of postobturation pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

盲法说明

Patients were blinded and were unaware of the specific treatment protocol. Participants were then randomly assigned to the four groups in a 1:1 ratio using a computer algorithm program (http:// randomizer.org)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Good oral hygiene,
  • Not reporting pain before the appointment
  • Asymptomatic irreversible pulpitis caused by deep carious lesions (vital cases),
  • Asymptomatic primary apical periodontitis (non-vital cases).

排除标准

  • Pregnancy,
  • Autoimmune diseases,
  • Uncontrolled diabetes,
  • Advanced periodontal disease (with 5 mm or more probing depth),
  • Patients requiring endodontic treatment for more than one tooth,
  • Unrestorable coronal destruction,
  • Incomplete root formation, systemic,
  • Allergic sensitivity to local anesthetic or NSAIDs.
  • ASA II patient
  • An analgesic or antibiotic intake the 7 days before the beginning of treatment

结局指标

主要结局

Change in pain from 6 th hours to 30 days between root canal sealers

时间窗: 6, 24, and 72 hours and at 7 and 30 days

All participants were asked to rate their perceived pain on the scale, with 0 indicating no pain and 10 indicating the highest possible pain. Pain levels were classified as none, mild (1 to 3), moderate (4 to 7), or severe (8 to 10).

次要结局

  • Change in pain from 6 th hours to 30 days between diffrernt pulp status(6, 24, and 72 hours and at 7 and 30 days,)

研究者

发起方
Kırıkkale University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali Turkyilmaz

Asisstant Professor

Kırıkkale University

研究点 (3)

Loading locations...

相似试验