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临床试验/CTRI/2026/01/102495
CTRI/2026/01/102495尚未招募Phase 3 4

Comparative evaluation of apical depth penetration and postoperative pain using 9% 1-Hydroxyethylidene-1, 1-Diphosphonic Acid (HEDP) as continuous chelation and 5% glycolic acid, 10% glycolic acid,17% EDTA as sequential chelation using sonic irrigation technique in symptomatic vital teeth: A double blinded randomized controlled trial.

Department of Conservative Dentistry and Endodontics1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年2月10日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
60
试验地点
1

研究概览

简要总结

This study will compare four different irrigation protocols in root canal treatment to assess their effectiveness in irrigant penetration and post-operative pain.

 Patient selection

 Patients who will fulfil inclusion criteria will be randomly divided into four groups:

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

Group 2: Sequential chelation with 2.5% NaOCl and 5% Glycolic acid.

Group 3: Sequential chelation with 2.5% NaOCl and 10% Glycolic acid.

Group 4:  Continuous chelation with 9% HEDP + 2.5% NaOCl.

 Root canal procedure:

 Patients will be anesthetized, isolated with a rubber dam, and canals will be accessed and prepared with ProTaper Gold instruments.

All four groups will receive irrigation after each file according to their respective group.

 Irrigant penetration evaluation:

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

 Post-operative procedure:

 After drying the canals, the tooth will be temporarily sealed, and patients will 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 will be 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
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Adult patients aged between 18-40 years.
  • Adult permanent symptomatic anterior or posterior teeth requiring treatment.
  • Pain at NRS scale above 4 cm level.
  • Feasibility of isolation of the tooth with a rubber dam.
  • 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.

研究者

发起方
Department of Conservative Dentistry and Endodontics
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Vineeta Nikhil

Subharti Dental College and Hospital/Swami Vivekanand Subharti University

研究点 (1)

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