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临床试验/NCT04944589
NCT04944589已完成不适用

Comparison of Post-operative Pain Frequency in Non-vital Teeth After Single Visit Root Canal Versus Multiple Visit Root Canal Treatment

Fatima Memorial Hospital2 个研究点 分布在 1 个国家目标入组 302 人开始时间: 2019年3月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
302
试验地点
2
主要终点
Comprision of Post-Operative pain Frequency

研究概览

简要总结

The objective of this study is:

  • To compare the post-operative pain frequency after single visit root canal versus multiple visit root canal treatment in patients with non-vital teeth
  • Post-operative pain is less frequent after single visit root canal than multiple visit root canal treatment in patients with non-vital teeth.

详细描述

METHODOLOGY This Randomized control trial was done in Outdoor patients Department of Operative Dentistry at Fatima Memorial Hospital. Informed written consent was taken from all patients who were willing to participate in the study. Patients who were diagnosed with non-vital teeth were considered for this study. Socio-demographic data and symptoms were recorded, subjects were examined and relevant investigations (vitality tests and radiographs) carried out. The patients were randomly divided into two groups through lottery method. Group A the treatment was done in one visit while in group B treatment was completed in two visits.

The standard procedure for both groups at first visit was administration of local anesthesia (1.8ml 2% Lignocaine with 1:10000 epinephrine), standard access cavity preparation followed by rubber dam isolation and pulp extirpation. After the confirmation of canal patency and working length radiograph, canals were prepared with the combination of hand files and engine-driven rotary nickel-titanium files (DENTSPLY Maillefer, Ballaigues, Switzerland) following manufacturer's instructions. 17%Ethylenediaminetetraacetic acid (EDTA )gel was used as a lubricant. Irrigation was performed with 2.5% NaOCl after each instrument in all cases. At the first visit, all teeth were prepared to working length and dried with paper points. Canals in Group A were filled with protaper universal gutta-percha (DENTSPLY Maillefer) and calcium hydroxide based sealer and restored with permanent restorative material in the same visit. In Group B after the canal preparation non-setting calcium hydroxide paste was placed with a sterile dry cotton pellet in the canal and tooth was restored with a minimum of 3.0mm Cavit. Patients in Group 2 were recalled after 1 week and the obturation technique same as Group 1 was followed in the second visit. After obturation, the patients in both the groups were recalled after 48 hours and assessed using visual analogue scale regarding presence and absence of post-operative pain. A value of 0-1 on Visual Analogue Scale (VAS) scale was considered as absence of pain.

The data was entered and analyzed in the SPSS-20. For descriptive analysis, mean and standard deviation was reported for age. Percentage for male and female participants was presented for gender distribution. The incidence of post-operative pain for single visit root canal and multiple visit root canal was determined. A chi-square test was used to determine the frequency of post-operative pain in both groups. A P value of 0.05 or less was taken as significant. Data was stratified more scientific manner in Pakistani population. So, the results of this study would add to the literature about the better, time saving and less painful (ROOT CANAL TREATMENT)RCT strategy in term of post- operative pain management.

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 (Investigator)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • • Patients within age range 20-40 years.
  • Male/Female
  • Mature permanent first and second molar teeth (maxillary and mandibular)
  • Non-vital teeth (As defined in operational definitions)

排除标准

  • • Any contraindication to local anesthesia, e.g. known allergy
  • Pregnancy.
  • endodontic re-treatment cases
  • Any physical or mental condition that would prevent jaw opening for the time required to complete the treatment.
  • Local acute infection/periapical radiolucency (diagnosed clinically, radio graphically )

结局指标

主要结局

Comprision of Post-Operative pain Frequency

时间窗: 6 months

After obturation, the patients in both the groups were recalled after 48 hours and assessed using visual analogue scale regarding presence and absence of post-operative pain. A value of 0-1 on VAS scale was considered as absence of pain

次要结局

未报告次要终点

研究者

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

Hma Tanvir

Principal Investigator

Fatima Memorial Hospital

研究点 (2)

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