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临床试验/CTRI/2025/03/083128
CTRI/2025/03/083128尚未招募不适用

COMPARATIVE EVALUATION OF APICAL DEPTH PENETRATION AND POSTOPERATIVE PAIN USING 9% 1-HYDROXYETHYLIDENE-1, 1-DIPHOSPHONIC ACID (HEDP) AS CONTINUOUS CHELATION AND 17% EDTA AS SEQUENTIAL CHELATION USING SONIC IRRIGATION TECHNIQUE IN SYMPTOMATIC VITAL TEETH: A RANDOMIZED CONTROLLED TRIAL

Its Dental college hospital and research centre1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年1月4日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
1. To evaluate and compare the apical depth penetration using 9% HEDP in combination with Sodium hypochlorite (NaOCl) with the standard irrigating protocol (17% EDTA + NaOCl) using sonic irrigation technique in symptomatic vital teeth.

研究概览

简要总结

This study compares two different irrigation protocols in root canal treatment to assess their effectiveness in irrigant penetration and post-operative pain:

Patient selection:

Patients are diagnosed and randomly divided into two groups:

Group 1**:** Sequential chelation with 2.5% NaOCl and 17% EDTA.

Group 2:  Continuous chelation with 9% HEDP + 2.5% NaOCl.

Root canal procedure:

Patients are anesthetized, isolated with a rubber dam, and canals are accessed and prepared with ProTaper Next instruments.

Both groups receive irrigation after each file: Group 1 with NaOCl and EDTA, Group 2 with NaOCl and HEDP.

Final irrigation steps differ between groups, with Group 1 using NaOCl and EDTA, and Group 2 using HEDP + NaOCl and saline.

Irrigant penetration evaluation:

After final irrigation, 1 ml of radio-opaque dye is injected into the canal and a radiograph is taken to evaluate the irrigant penetration.

Post-operative procedure:

After drying the canals, the tooth is temporarily sealed, and patients return for obturation and post-operative restoration.

Pain evaluation:

Post-operative pain is recorded at 6, 24, and 48 hours using the NRS pain scale. If pain persists, patients are prescribed an escape drug and excluded from the study.

This study aims to determine which irrigation method provides better irrigant penetration and reduces post-operative pain.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 30.00 Year(s)(—)
性别
All

入选标准

  • 1.Adult patients aged between 18-30 years.
  • 2.Adult permanent symptomatic anterior or posterior teeth requiring treatment.
  • 3.Pain at NRS scale above 4 cm level.
  • 4.Feasibility of isolation of the tooth with a rubber dam.
  • 5.Participants with the ability to understand the consent forms.

排除标准

  • Perforation cases
  • Periodontally compromised tooth.
  • Patients not willing for the treatment
  • Patients allergic to iodine.
  • Non-negotiable canals.

结局指标

主要结局

1. To evaluate and compare the apical depth penetration using 9% HEDP in combination with Sodium hypochlorite (NaOCl) with the standard irrigating protocol (17% EDTA + NaOCl) using sonic irrigation technique in symptomatic vital teeth.

时间窗: after procedure

次要结局

  • To evaluate and compare the post-operative pain using 9% HEDP in combination with Sodium hypochlorite (NaOCl) with the standard irrigating protocol (17% EDTA + NaOCl) using sonic irrigation technique in symptomatic vital teeth.(Post operative pain will be checked after 6, 24 and 48 hours.)

研究者

发起方
Its Dental college hospital and research centre
申办方类型
Research institution and hospital

研究点 (1)

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