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临床试验/CTRI/2025/11/097136
CTRI/2025/11/097136
尚未招募
4 期

Postoperative Pain Following Glide Path Preparation Using Two NiTi File Systems in Optimum Glide Path 2 (OGP 2) Motion: A Randomized Controlled Trial

Goa Dental College and Hospital,1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年11月25日最近更新:

概览

阶段
4 期
状态
尚未招募
发起方
Goa Dental College and Hospital,
入组人数
40
试验地点
1
主要终点
Postoperative pain (VAS 0–10) recorded at baseline, 6 hrs, 12 hrs, 24 hrs and 48 hours post-treatment.

概览

简要总结

This randomized clinical trial aims to compare postoperative pain following root canal preparation using Proglider versus VDW Rotate in adults requiring endodontic treatment of multiple rooted teeth. A total of 40 participants will be randomly assigned to one of the two groups. Postoperative pain will be assessed using a visual analogue scale (VAS) immediately after treatment (baseline), and at 6, 12, 24, and 48 hours post-procedure. The study is participant- and outcome-assessor–blinded to reduce bias.

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 60.00 Year(s)(—)
性别
All

入选标准

  • Clinical inclusion criteria 2.No Medical History.
  • 3.Only one tooth per subject included.
  • 4.Asymptomatic maxillary and mandibular first or second molars with necrotic pulp periapical lesions.
  • Radiographic inclusion criteria 1.Carious lesion involving the pulp space.
  • 2.Periapical rarefaction up to Periapical index score 3 (PAI score 1 to 3) 3.Normal radiographic appearance with healthy supporting tissues.

排除标准

  • 1.If the #15K-file crossed the apex without resistance or the #08K-file could not reach the working length, the teeth were excluded from the analysis.
  • 2.Presence of acute or chronic apical abscess, acute pain at presentation.
  • 3.Presence of any systematic illness.
  • 4.Presence of swelling, pathological mobility, or sinus tract.
  • 5.History of use of antibiotics in the preceding 7 days.
  • 6.History of allergy to local anaesthetics.
  • 7.Presence of progressive periodontal disease.
  • 8.Pregnant or lactating women.
  • 9.Teeth with calcified, resorbed, or complex canal anatomy, vital pulp, previous endodontic treatment, or deemed unrestorable/severely damaged.

结局指标

主要结局

Postoperative pain (VAS 0–10) recorded at baseline, 6 hrs, 12 hrs, 24 hrs and 48 hours post-treatment.

时间窗: Baseline: Immediately after treatment | 6 hours post-treatment | 12 hours post-treatment | 24 hours post-treatment | 48 hours post-treatment

次要结局

  • 1. Analgesic intake (Number of analgesic intake)(2. Flare-ups/abscess formation requiring intervention)

研究者

发起方
Goa Dental College and Hospital,
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Aswathy Suresh Kumar

Goa Dental College and Hospital

研究点 (1)

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