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临床试验/NCT03478241
NCT03478241已完成不适用

Postoperative Pain Intensity Associated With the Use of Different Nickel Titanium Instrumentation Systems During Single-Appointment Non-Surgical Endodontic Retreatment: A Randomized Clinical Trial

Istanbul Medipol University Hospital0 个研究点目标入组 99 人开始时间: 2016年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
99
主要终点
Change from Baseline in Postoperative Pain after single appointment retreatment at 1 month

研究概览

简要总结

In this study the effect of different engine-driven nickel titanium (Ni-Ti) instrumentation systems (OneShape, Revo S and WaveOne) on postoperative dental pain in patients with asymptomatic teeth after a single-appointment root canal retreatment was evaluated.

详细描述

The aim of this clinical study was to evaluate the effect of different engine-driven nickel titanium (Ni-Ti) instrumentation systems (OneShape, Revo S and WaveOne) on postoperative dental pain in patients with asymptomatic teeth after a single-appointment root canal retreatment. A total of a hundred thirty nine patients with asymptomatic teeth and with no contradictory medical history who were indicated for non-surgical retreatment at the Endodontic Clinic, Faculty of Dentistry, Istanbul Medipol University, between September and December 2016 were included in this study. All of the patients have been recruited from the Istanbul Medipol University Dental Clinics in Istanbul. Out of a hundred thirty nine patients, a total of ninety-nine patients who met the inclusion criteria and agreed to participate was enrolled for the study and were divided into three groups (n=33). Consent was obtained from all study participants before the treatment. After removing previous root canal filling, instrumentation was performed using One Shape, Revo-S, and WaveOne in groups 1, 2, and 3, respectively. All retreatments were performed in a single appointment by one endodontist before permanent coronal restoration. Postoperative pain intensity was assessed at 6, 12, 18, 24, 48, and 72 h; 7 days; and 1 month after the retreatment. The teeth was examined according to for pain intensity, percussion & palpation sensitivity, swelling, analgesic intake and clinical status.

研究设计

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

盲法说明

the patient did not know which shaping system was used on them

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Asymptomatic teeth
  • Patients with no contradictory medical history
  • Patients who were indicated for non-surgical retreatment and
  • Patients who were above 18 years old

排除标准

  • Patients aged below 18 years;
  • Symptomatic teeth,
  • Teeth with vertical root fractures
  • Teeth with excessive periodontal disease;
  • Patients who received or required surgical endodontic treatment
  • Patients diagnosed with systemic diseases
  • Patients who used analgesics 12 h before or
  • Patients who used antibiotics 1 month before the retreatment

研究组 & 干预措施

Group 1: single file rotary motion

Active Comparator

after the previous root canal filling was removed, the shaping procedure of the root canal system was carried out using OneShape Ni-Ti system.

干预措施: Group 1: single file rotary motion (Device)

Group 2: multiple file rotary motion

Active Comparator

after the previous root canal filling was removed, the shaping procedure of the root canal system was carried out using Revo S Ni-Ti system.

干预措施: Group 2: multiple file rotary motion (Device)

Group 3: single file reciprocal motion

Active Comparator

after the previous root canal filling was removed, the shaping procedure of the root canal system was carried out using WaveOne Ni-Ti system.

干预措施: Group 3: single file reciprocal motion (Device)

结局指标

主要结局

Change from Baseline in Postoperative Pain after single appointment retreatment at 1 month

时间窗: 6, 12, 18, 24, 48, and 72 h; 7 days; and 1 month

The primary outcome measure of the study was to assess if different nickel titanium root canal shaping systems influence the intensity and duration of postoperative pain in single-visit non-surgical root canal re-treatments. Postoperative pain was recorded using a four-level verbal rating scale, where 0 indicated no pain, 1 indicated slight pain, 2 indicated moderate pain, and 3 indicated sever pain. the patients were asked to return to the clinic for assessing postoperative pain (tenderness to palpation and percussion) at 24, 48, and 72 h; 7 days; and 1 month after the treatment. One clinician performed all the assessments at 24, 48, and 72 h; 7 days; and 1 month.

次要结局

未报告次要终点

研究者

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

Tan Firat Eyuboglu

Assistant Professor

Istanbul Medipol University Hospital

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