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临床试验/NCT03527602
NCT03527602Unknown不适用

Enlargement of Apical Foramen in Anterior Teeth With Apical Periodontitis and Postoperative Pain and Flare-up Rate.

Isparta Military Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年11月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
2
主要终点
100-mm Visual Analog Scale (VAS).

研究概览

简要总结

The purpose of this study is to determine whether enlarging the apical foramen causes postoperative pain in maxillary anterior teeth with apical periodontitis.

详细描述

Foraminal enlargement (FE) is an intentional procedure that enlarges the cement canal. However, some RCTs indicate that enlarging the FE causes postoperative pain, flare-up, and destroy the apical constriction, whilst some RCTs pointed out there is no difference in terms of pain when a FE has been performed in maxillary anterior teeth with apical periodontitis. We will assess the risk of postoperative pain as risk ratio (RR). The binary (dichotomous) data: 0-44 mm: Mild or no pain; 45-100 mm: Moderate to severe pain.

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 (Participant)

盲法说明

Single-blind. (Participants)

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

  • Mature permenent maxillary anterior teeth having pulpal necrosis and apical periodontitis.

排除标准

  • Systemic disorders, diabetes, pregnancy, less than 18 years of age, immunocompromised, patients who had taken antibiotics in the past 1 month, patients who had a positive history of analgesic use within the past 3 days, previously accessed teeth.

研究组 & 干预措施

Intervention

Experimental

Endodontic treatment will be performed in maxillary anterior teeth with necrotic pulp and periapical periodontitis. Local anaesthesia will be provided (2% Novocaine with 1:80,000 epinephrine), isolation with rubber dam and standard access cavity preparation will be done.Using 2.5 % sodium hypochlorite, canal negotiation will be done. Foraminal enlargement will be achieved with rotary files in foraminal enlargement group after determining working length. Coronal flaring with # 2 and #3 Gates-Glidden drills will be done. The canals will be obturated with gutta-percha and epoxy resin sealer. The treatments will be carried out in single-visit.

干预措施: Foraminal enlargement (Procedure)

Control

No Intervention

In the control group, no foraminal enlargement will be performed.

结局指标

主要结局

100-mm Visual Analog Scale (VAS).

时间窗: 5 days

The severity of pain in 12 h, 24 h, and 2, 3, 4, and 5 days according to the VAS: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)

次要结局

  • The number of patients taking an analgesic following the endodontics treatment.(5 days)

研究者

发起方
Isparta Military Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ibrahim Ethem YAYLALI

Head of Dentistry

Isparta Military Hospital

研究点 (2)

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