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临床试验/CTRI/2025/07/090142
CTRI/2025/07/090142
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Comparative assessment of postoperative pain following three different irrigation activation techniques in endodontic therapy of single-rooted teeth: A randomized clinical study.

Dr. Mokshada Ravindra Kasod1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年7月14日最近更新:

概览

阶段
不适用
状态
已完成
发起方
Dr. Mokshada Ravindra Kasod
入组人数
60
试验地点
1
主要终点
The study will help in selecting the most effective irrigation activation method to minimize postoperative pain, enhancing patient comfort and satisfaction.

概览

简要总结

Total 60 single rooted teeth indicated for root canal treatment will be included in the study.

Informed consent will be obtained from patients.

Preoperative radiographs of selected teeth will be taken to ensure the inclusion criteria.

Patients will be asked to quantify their pain on a Visual Analog Pain Intensity Scale, prior giving suitable anesthesia.

Rubber dam application will be done

Access opening with endodontic access burs and minimal instrumentation with a 15-size K-file will be done

Biomechanical Preparation of canals will be performed up to a standard size (Step back technique, three sizes beyond the size of the first instrument that binds), with 5.25% sodium hypochlorite irrigation.

Randomization of the participants will be done by chit system before selecting final irrigation protocol.

Single blinding will be followed.

On the basis of the final irrigation protocol, the patients will be allotted one of the three groups:

Groups:

1.     Conventional syringe irrigation (CSI)

2.     Sonic activation (SA)

3.     Negative pressure irrigation (NPI)

The final irrigation in Group 1 will be done with 5.25%  NaOCl using a 30G, 27 mm side-vent needle (Irriflex, PD Swiss), 1 mm from the working length for 3 min (flow rate, 2 mL/min).

In Group 2: The irrigant will be introduced as in Group A and agitated with Endoactivator(Dentsply Sirona,Maillefer).The irrigation protocol will be similar to that used in Group A, but the irrigants were agitated using polymer tips(Dentsply Sirona, Maillefer Endoactivtor activator Tips) for 30 s before changing the solution

In Group 3: : Irrigant will be delivered by a syringe and needle inside the pulp chamber and a fine suction tip(Endoaspirator Pro-Cerkamed) will be placed near the working length which will create the necessary negative pressure that drives the irrigant into the canal.

Patient will be given a temporary dressing(Cavit-G) and will be recalled for obturation.

Following the intervention, patients will be given postoperative forms to record pain levels. They will receive instructions to record Visual Analog Scale pain scores at 6, 12, 24, and 48 h postoperatively, with messages sent as reminders. They will be asked to categorise their pain experience into five categories: 0 (no pain), 1–3 (mild pain), 3–5 (moderate pain), 5–9 (severe pain), and 10(worst possible pain).

If pain was unmanageable, patients will be informed to contact the principal investigator. Ibuprofen 400 mg (Abbott, India) will be prescribed as a rescue drug. Data recorded after the time of taking rescue drug will be excluded from the study.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • Patients diagnosed with symptomatic or asymptomatic irreversible pulpitis , apical periodontitis requiring root canal therapy in single rooted teeth.

排除标准

  • Multi-rooted Maxillary and Mandibular teeth -Patients with systemic conditions affecting pain perception, retreatment cases.
  • Patients with apical abscess.
  • Patient requiring antibiotic medications.

结局指标

主要结局

The study will help in selecting the most effective irrigation activation method to minimize postoperative pain, enhancing patient comfort and satisfaction.

时间窗: 6, 12, 24, and 48 hours | postoperatively

次要结局

  • Need of Analgesic intake after root canal therapy.(6, 12, 24, and 48 hours)

研究者

发起方
Dr. Mokshada Ravindra Kasod
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Mokshada Ravindra Kasod

SMBT Institute of Dental Sciences and Research,Nashik

研究点 (1)

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