The Effect of Ibuprofen Sustained Release Oral Premedication on Intraoperative and Postoperative Pain After Single-visit Root Canal Treatment of Mandibular Molars With Symptomatic Irreversible Pulpitis and Apical Periodontitis
试验速览
- 阶段
- 不适用
- 入组人数
- 48
- 主要终点
- Efficacy of buccal infiltration anaesthesia measured using Visual analogue scale
研究概览
简要总结
The study is conducted to evaluate the effect of Ibuprofen sustained release premedication on the success of buccal infiltration anaesthesia, intaroperative pain and post operative pain in mandibular molars with symptomatic irreversible pulpitis and apical periodontitis
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Triple
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy patients (ASA I or II).
- •Patients with Mandibular molar teeth diagnosed with:
- •Pre-operative sharp pain marked on VAS scale by reading not less than
- •Vital exaggerated response of pulp tissue to cold pulp tester (ethyl chloride spray) and electric pulp tester.
- •Normal periapical radiographic appearance or slight widening in lamina dura.
- •Positive response and pain provoked by percussion.
排除标准
- •Allergy to Ibuprofen
- •Medically compromised patients having significant systemic disorders. (ASA III or IV).
- •History of intolerance to NSAIDS.
- •Patients with two or more adjacent teeth requiring endodontic treatment.
- •Pregnant or nursing females.
- •Teeth that have:
- •Periodontal affection (with pocket depth greater than 5mm, associated with swelling or fistulous tract, or greater than grade I mobility)
- •No possible restorability.
研究组 & 干预措施
Ibuprofen sustained release
Single dose of 800 mg Brufen Retard oral premedication will be administered 1 hour before local anesthesia
干预措施: Brufen Retard (Drug)
Placebo
1 capsule of 500 mg of glucose oral premedication will be adminstered 1 hour before local anesthesia
干预措施: Brufen Retard (Drug)
结局指标
主要结局
Efficacy of buccal infiltration anaesthesia measured using Visual analogue scale
时间窗: During root canal treatment procedures
intensity of pain during root canal treatment procedures is recorded by the patient using VAS where 0=no pain, 1-3=mild pain, 4-6=moderate pain and 7-10=severe pain
次要结局
- Intensity of intraoperative pain(During root canal treatment procedures)
- Number of needed analgesic tablets in case of intolerable pain(up to 48 hours after endodontic treatment)
- Postoperative pain(up to 48 hours after endodontic treatment)
研究者
Mariam Ahmed Hossam
Resident at faculty of dentistry, Cairo University
Cairo University