跳至主要内容
临床试验/NCT05306535
NCT05306535已完成不适用

Effect of Occlusal Reduction on Relief of Pain and Sensitivity to Percussion in Patients With Irreversible Pulpitis and Symptomatic Apical Periodontitis Treated in a Single Visit- a Randomized Clinical Trial

Altamash Institute of Dental Medicine1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2022年4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
入组人数
56
试验地点
1
主要终点
Post Obturation pain

研究概览

简要总结

One of the most important aspects of endodontic practice is to abate pain during and post root canal treatment. An endodontist by all means should provide a painless endodontic treatment to their patients. This study is carried out to determine the effect of occlusal reduction on relief of pain and percussion in patients with irreversible pulpitis and symptomatic apical periodontitis treated in a single visit root canal treatment. Pain will be assessed preoperatively and then post operatively after completion of the root canal at 6 hours, 12 hours, 24 hours, 48 hours and 72 hours following obturation of root canal.

详细描述

The objective of this randomized clinical trial is to evaluate the impact of occlusal reduction on the incidence of post obturation pain. 56 patients will be allocated randomly into 2 groups keeping 28 patients in each group which will meet the inclusion criteria of the study, patients diagnosed with symptomatic irreversible pulpitis and symptomatic apical periodontitis and requiring porcelain fused to metal crown with age ranging from 18 to 50 years. In the interventional group 2mm reduction will be done and assessment will be done to confirm the absence of occlusal contact while in control group no modification will be carried out on the occlusal surface. Single visit endodontic treatment will be carried out with 2.5% sodium hypochlorite for disinfection of the canal followed by crown down technique using rotary nickel titanium files for shaping the canals followed by obturating the canals with lateral condensation technique.

Pain will be assessed preoperatively and then post operatively at 6 hours, 12 hours, 24 hours, 48 hours and 72 hours following obturation of root canal. Visual Analogue Scale (VAS) will be used as a primary outcome measure.The VAS consists of a 10-cm line having two extremes NO PAIN and Extreme pain. Patients will be asked to choose the mark that represents their level of pain at the intervals mentioned above . Pain level are assigned to one of four categorical scores

1, None(0); 2, Mild (1-3) ; 3 Moderate (4-6); 4, Severe (7-10) 10. Tenderness to percussion will be evaluated postoperatively at 48 hour with readings either positive to tenderness or negative to tenderness Positive to tenderness will evaluate treatment not effective Negative to tenderness at 48 hour post obturation will evaluate treatment effectiveness Patients will be given placebo for administration in case severe pain and ibuprofen 400mg if the pain persisted. Documentation of intake of either placebo or analgesic will be done by the patient.

研究设计

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

入排标准

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

入选标准

  • •No medical history
  • •patients suffering from Symptomatic Irreversible Pulpitis
  • •patients suffering from Apical Periodontitis
  • •patients requiring porcelain fused to metal crown

排除标准

  • •Patients who were not suitable for conventional root canal treatment
  • •multirooted teeth

研究组 & 干预措施

occlusal reduction

Experimental

Performing occlusal reduction on the experimental tooth until absence of occlusal contact is confirmed following completion of the endodontic treatment

干预措施: Occlusal reduction (Procedure)

control

No Intervention

No occlusal reduction or modification of the occlusal anatomy will be performed

结局指标

主要结局

Post Obturation pain

时间窗: 6 hours upto 48 hours following obturation

Postobturation pain is measured using the visual analogue scale(VAS) with readings from 0-10 where 0 represents no pain and 10 represents the worst pain measured.

Tenderness to percussion

时间窗: At 48 hours post completion of the root canal treatment

Tenderness to percussion will be evaluated (score 0: no pain, score 1: slight pain score 2: severe pain)

次要结局

  • Incidence of placebo and analgesic intake(from 6 hours up to 48 hours following completion of root canal)

研究者

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

Hira Abbasi

Principal Investigator

Altamash Institute of Dental Medicine

研究点 (1)

Loading locations...

相似试验