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临床试验/NCT04250519
NCT04250519Unknown1 期

Assessment of Post Operative Pain Following Root Canal Retreatment in Molars Using Four Different Combination of Irrigants : A Prospective Clinical Study

Tamil Nadu Dr.M.G.R.Medical University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年2月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
发起方
入组人数
150
试验地点
1
主要终点
post operative pain evaluation using various combination of irrigants: VAS score

研究概览

简要总结

This study evaluates the efficacy of dexamethasone as a intracanal irrigant along with sodium hypochlorite 1% and 5.25% concentrations in post treatment pain for molar root canal retreatment.

详细描述

Main objective of root canal retreatment is to alleviate pain and disinfect the rootcanal .However some patients may experience mild to severe pain following treatment , which leads to intake of painkillers orally for post operative pain management.

So , this study evaluates the efficiency of dexamethasone used as intracanal irrigant in post treatment pain for molar root canal retreatment sodium hypochlorite (1% &5.25%) is used for disinfecting the canals patients will be grouped into Symptomatic and Asymptomatic patients requiring root canal retreatment and irrigants will be used in various combinations as mentioned below

  1. 1% sodium hypochlorite alone 2.5ml in each canal along with ultrasonic activation
  2. 1% sodium hypochlorite and dexamethasone 4mg,2.5ml in each canal along with ultrasonic activation
  3. 5.25% sodium hypochlorite alone 2.5ml in each canal along with ultrasonic activation
  4. 5.25% sodium hypochlorite and dexamethasone 4mg, 2.5ml in each canal along with ultrasonic activation calcium hydroxide is commonly used as intracanal medicament in all the patients post operative symptoms is evaluated at 12 hrs , 24 hrs,48 hrs, 72 hrs and 1 week followed by obturation is completed

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
Double (Participant, Investigator)

入排标准

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

入选标准

  • teeth previously treated or attempted root canal treatment,
  • teeth with or without symptoms,
  • periapical radiograph showing evidence of inadequate previous root canal treatment or periapical changes,
  • only teeth or at least one canal where complete removal of root canal filling material was possible and reach the working length in first appointment.

排除标准

  • patient not willing for follow up,
  • teeth with extensive cervical or apical resorption that restricted the use of sodium hypochlorite irrigation,
  • teeth with poor periodontal status, teeth not suitable for post endodontic restoration,
  • patients with acute periapical abscess,
  • patients with systemic conditions preventing radiograph exposure or multi visit treatment,
  • pregnant patients,
  • patients with allergy to any known dental materials.

研究组 & 干预措施

1% sodium hypochlorite & dexamethasone 4mg as irrigants

Experimental

sodium hypochlorite is effective in any concentration as antimicrobial irrigant and dexamethasone is anti inflammatory drug

干预措施: Sodium Hypochlorite (Drug)

1% sodium hypochlorite as irrigant &normal saline as placebo

Active Comparator

sodium hypochlorite is effective in any concentration as irrigant

干预措施: Sodium Hypochlorite (Drug)

5.25% sodium hypochlorite and dexamethasone 4mg as irrigants

Experimental

sodium hypochlorite is effective in any concentration as antimicrobial irrigant and dexamethasone is anti inflammatory drug

干预措施: Sodium Hypochlorite (Drug)

5.25% sodium hypochlorite &normal saline as placebo

Active Comparator

sodium hypochlorite is effective in any concentration as irrigant

干预措施: Sodium Hypochlorite (Drug)

结局指标

主要结局

post operative pain evaluation using various combination of irrigants: VAS score

时间窗: After 7 days

pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced \[1-3\] mild pain , \[4-7\] moderate pain , \[8-10\] severe pain .

次要结局

  • assessment of other variables in pain scale(through study completion, an average of 1 week)

研究者

发起方
Tamil Nadu Dr.M.G.R.Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. CT. VALLIAPPAN

Principal Investigator

Tamil Nadu Dr.M.G.R.Medical University

研究点 (1)

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