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临床试验/NCT06980870
NCT06980870招募中2 期

Effect of Pre-medication With Anti-inflammatory Drugs(Ibuprofen and Dexamethasone)on Post-Endodontic Pain With Symptomatic Irreversible Pulpitis

Armed Forces Institute of Dentistry, Pakistan1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2025年2月15日最近更新:
干预措施
相关药物

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
130
试验地点
1
主要终点
effect of pre-medication(ibuprofen and dexamethasone ) on post-endodontic pain

研究概览

简要总结

Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain with symptomatic irreversible pulpitis

详细描述

Study will be conducted after the approval of Institutional Ethics Review Committee, AFID (ANX "A").

A total of 130 entitled patients reporting to Operative Dentistry Department, Armed Forces Institute of Dentistry will be invited for participation in this study. The procedure will be explained to the patients and their parents in Urdu language and a written informed consent will be taken (ANX "B") They will be screened for inclusion by taking history, performing relevant clinical examination and necessary tests along with peri-apical radiographs. Patients fulfilling the inclusion criteria will be divided into two groups using consecutive non random sampling.

Group 1: Patients treated with premedication of Non steroidal anti inflammatory drug (Ibuprofen) Group 2: Patients treated with premedication of Steroidal anti inflammatory drug (Dexamethsone)

Both groups will receive medication 15 mins before intiating root canal treatment. Root canal treatment will then be initiated under local anesthesia and rubber dam isolation. Working length will be taken 1mm from radiographic apex with apex locator and will be confirmed with radiograph. The root canals will be instrumented with ProTaper Next system under copious irrigation with 5.25% sodium hypochlorite (NaOCl). Patency will be confirmed with a #10 K file between each instrument change. The root canals will be flushed with 5 mL of 17% EDTA solution. To control the microbiological impact on post-operative pain calcium hydroxide will be used as an intra-canal medicament and likewise 5.25% sodium hypochlorite as an irrigant in both groups. Following instrumentation and calcium hydroxide placement in the canal using lentulo spirals, the cavity will be temporarily sealed with cavit.

At the end of every appointment, patient will be given a visual analogue scale. The patient will be advised to mark the line corresponding with the intensity of his pain at 24, 48 and 72 hours after the first visit. The patient will be recalled after one week for obturation and final full coverage restoration. Analgesics will be prescribed in case of severe intolerable pain.

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
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Permanent teeth with acutely inflamed pulp without swelling or draining sinus.
  • Patients of either gender aged between 18-50 years old.
  • Systemically healthy patients.
  • Patients who agree to attend for recall appointments and provide a written consent.

排除标准

  • Patients on preoperative analgesics and antibiotics.
  • Teeth with calcified canals and previously treated teeth.
  • Pregnant and lactating mothers.
  • Patients who are immunocompromised, anxious and mentally handicapped.
  • Patients who are allergic to any of the test medications.

研究组 & 干预措施

Pain with ibuprofen

Active Comparator

Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain

干预措施: Anti-inflammatory drug (ibuprofen) (Drug)

Pain with dexamethasone

Active Comparator

Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain

干预措施: Anti-inflammatory drug (dexamethsaone) (Drug)

结局指标

主要结局

effect of pre-medication(ibuprofen and dexamethasone ) on post-endodontic pain

时间窗: 72 hours

Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain on visual analogue scale

次要结局

未报告次要终点

研究者

发起方
Armed Forces Institute of Dentistry, Pakistan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Qurat-ul-ain Abbasi

Post-Graduate Resident Operative Dentistry & Endodontic

Armed Forces Institute of Dentistry, Pakistan

研究点 (1)

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