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临床试验/NCT05841290
NCT05841290招募中不适用

The Incidence of Postoperative Pain After Using Different Types of Sealers (A Randomized Clinical Trial)

British University In Egypt1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年8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
招募中
入组人数
50
试验地点
1
主要终点
Postoperative pain

研究概览

简要总结

The aim of this randomized clinical trial is to evaluate and compare the incidence and intensity of post-operative pain after obturation using resin and silicon-based sealers.

详细描述

The main objectives of root canal therapy are to achieve long-term comfort, function, and aesthetics for the patients and prevention of reinfection of tooth. These objectives are provided through complete cleaning, shaping, and obturation of canals of affected teeth .

Some patients may report moderate-to-severe pain and/or swelling following root canal treatment .

This is detrimental for both patient and dentist and may entail an unscheduled emergency visit by patients to relieve their symptoms.

Postoperative pain is considered a clinical outcome that exhibits the multifactorial nature of patients' responses to variables among treatment procedures such as maintaining the working length to the apical constriction, finishing the endodontic treatment in single visit or multiple visit, instrumentation technique and the type of endodontic sealer used for obturation .

Such pain occurrence is mainly due to mechanical, chemical or microbial injury to the periapical tissues .

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
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • • Patient's age ranges from 18-50 years old.
  • Patients with teeth diagnosed with symptomatic irreversible pulpitis.
  • Normal periapical condition confirmed by normal periapical radiograph
  • The teeth are restorable
  • Teeth are periodontally free, with no mobility and negative to percussion and palpation test.

排除标准

  • • Teeth with immature roots
  • Non restorable teeth
  • Medically compromised patients with systemic complication that would alter the treatment.
  • Necrotic teeth
  • Teeth with apical periodontitis or periapical lesions
  • necrotic Teeth.

研究组 & 干预措施

Group (1) Resin Based Sealer intervention

Experimental

evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.

干预措施: Primary local anesthesia (Procedure)

Group (1) Resin Based Sealer intervention

Experimental

evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.

干预措施: Supplemental local anesthesia (Procedure)

Group (1) Resin Based Sealer intervention

Experimental

evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.

干预措施: Removal Of Caries and Access Cavity (Procedure)

Group (1) Resin Based Sealer intervention

Experimental

evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.

干预措施: Rubber dam isolation of tooth (Procedure)

Group (1) Resin Based Sealer intervention

Experimental

evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.

干预措施: Bleeding control (Procedure)

Group (1) Resin Based Sealer intervention

Experimental

evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.

干预措施: Canal negotiation (Procedure)

Group (1) Resin Based Sealer intervention

Experimental

evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.

干预措施: Coronal flaring (Procedure)

Group (1) Resin Based Sealer intervention

Experimental

evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.

干预措施: Working Length Determination (W.L) (Procedure)

Group (1) Resin Based Sealer intervention

Experimental

evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.

干预措施: Glide path (Procedure)

Group (1) Resin Based Sealer intervention

Experimental

evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.

干预措施: Irrigation (Procedure)

Group (1) Resin Based Sealer intervention

Experimental

evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.

干预措施: Cleaning and shaping using rotary system (Procedure)

Group (1) Resin Based Sealer intervention

Experimental

evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.

干预措施: Second w.l determination (Procedure)

Group (1) Resin Based Sealer intervention

Experimental

evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.

干预措施: Apical gauging (Procedure)

Group (1) Resin Based Sealer intervention

Experimental

evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.

干预措施: Activation of the irrigant (Procedure)

Group (1) Resin Based Sealer intervention

Experimental

evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.

干预措施: Master cone check (Procedure)

Group (1) Resin Based Sealer intervention

Experimental

evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.

干预措施: application of resin based sealer inside the canal in the resin based sealer group (Drug)

Group (1) Resin Based Sealer intervention

Experimental

evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.

干预措施: application of the sillicon based sealer inside the canal in the sillicon based group (Diagnostic Test)

Group (1) Resin Based Sealer intervention

Experimental

evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.

干预措施: Obturation (Procedure)

Group (1) Resin Based Sealer intervention

Experimental

evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.

干预措施: Visual Analogue Scale (VAS) (Diagnostic Test)

Group (2) Silicone Based Sealer intervention

Experimental

evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.

干预措施: Primary local anesthesia (Procedure)

Group (2) Silicone Based Sealer intervention

Experimental

evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.

干预措施: Supplemental local anesthesia (Procedure)

Group (2) Silicone Based Sealer intervention

Experimental

evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.

干预措施: Removal Of Caries and Access Cavity (Procedure)

Group (2) Silicone Based Sealer intervention

Experimental

evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.

干预措施: Rubber dam isolation of tooth (Procedure)

Group (2) Silicone Based Sealer intervention

Experimental

evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.

干预措施: Bleeding control (Procedure)

Group (2) Silicone Based Sealer intervention

Experimental

evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.

干预措施: Canal negotiation (Procedure)

Group (2) Silicone Based Sealer intervention

Experimental

evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.

干预措施: Coronal flaring (Procedure)

Group (2) Silicone Based Sealer intervention

Experimental

evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.

干预措施: Working Length Determination (W.L) (Procedure)

Group (2) Silicone Based Sealer intervention

Experimental

evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.

干预措施: Glide path (Procedure)

Group (2) Silicone Based Sealer intervention

Experimental

evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.

干预措施: Irrigation (Procedure)

Group (2) Silicone Based Sealer intervention

Experimental

evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.

干预措施: Cleaning and shaping using rotary system (Procedure)

Group (2) Silicone Based Sealer intervention

Experimental

evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.

干预措施: Second w.l determination (Procedure)

Group (2) Silicone Based Sealer intervention

Experimental

evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.

干预措施: Apical gauging (Procedure)

Group (2) Silicone Based Sealer intervention

Experimental

evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.

干预措施: Activation of the irrigant (Procedure)

Group (2) Silicone Based Sealer intervention

Experimental

evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.

干预措施: Master cone check (Procedure)

Group (2) Silicone Based Sealer intervention

Experimental

evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.

干预措施: application of resin based sealer inside the canal in the resin based sealer group (Drug)

Group (2) Silicone Based Sealer intervention

Experimental

evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.

干预措施: application of the sillicon based sealer inside the canal in the sillicon based group (Diagnostic Test)

Group (2) Silicone Based Sealer intervention

Experimental

evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.

干预措施: Obturation (Procedure)

Group (2) Silicone Based Sealer intervention

Experimental

evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.

干预措施: Visual Analogue Scale (VAS) (Diagnostic Test)

结局指标

主要结局

Postoperative pain

时间窗: after 72 hours of endodontic treatment

Pain is evaluated using visual analogue scale (VAS) which is a pain rating scale. Scores are based on measures that are self-reported of symptoms that are recorded through a single handwritten mark placed at one point along the length of a 10-cm line representing a continuum between the two ends of the scale; on the left end of the scale (0 cm) means "no pain" and the on the right end of the scale (10 cm) "worst 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

Kareem darwish

Teaching Assistant, Endodontics department , Faculty of dentistry brititsh university in egypt

British University In Egypt

研究点 (1)

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