Comparative Evaluation of the Analgesic Effect of various Premedications on Pulpal Sensibility Tests at Different Time Intervals in Patients with Endodontic Pain: A Clinical Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To assess the effect of combination of Ibuprofen (400 mg) and Paracetamol/Acetaminophen(325 mg) on Electric pulp testing and cold test
研究概览
简要总结
**Introduction:**Accurate diagnosis of symptomatic irreversible pulpitis (SIP) requires correlating patient-reported symptoms with clinical findings through diagnostic tests such as cold test and electric pulp testing (EPT). However, premedication with analgesics may influence test outcomes and pain perception, which has not been extensively evaluated.
Aim: To evaluate the effect of ibuprofen (400 mg) + paracetamol/acetaminophen (325 mg), and ketorolac tromethamine (20 mg) as premedication on cold test and EPT responses in patients with endodontic pain.
Materials and Methodology: This prospective, randomized, double-blind, placebo-controlled clinical trial will include 120 patients diagnosed with SIP. Baseline pain will be recorded using the Heft-Parker Visual Analog Scale (HP-VAS). Patients will then be randomly allocated into three groups (n = 40 each):
- Group A: Ibuprofen (400 mg) + Paracetamol (325 mg) (Combiflam)
- Group B: Ketorolac Tromethamine (20 mg) (Ketorol DT)
- Group C: Placebo (glucose)
Capsules were identical in appearance, coded, and dispensed by a person not involved in the trial to ensure allocation concealment. Cold test and EPT will be performed on the affected tooth, adjacent tooth, and contralateral tooth at 20, 40, and 60 minutes after administration. EPT will be carried out with a toothpaste-coated electrode placed on the buccal surface, and patients will indicate the first definite sensation. Cold testing will be done with Endo Ice on a large cotton pellet applied to intact tooth structure. After each test, patients will record their pain levels on the HP-VAS.
Expected Outcomes: The study seeks to determine whether premedication significantly alters diagnostic test responses and pain intensity compared with placebo. The findings may provide clinical evidence for optimizing analgesic premedication protocols in endodontic patients, improving both diagnostic reliability and patient comfort
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator 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
- •Chief complaints should include cold/hot drinks cause lingering pain.
- •Actively experiencing moderate to severe pain
- •Mature permanent vital mandibular molar.
- •Systemically healthy patients.
- ••Teeth having sufficient tooth structure for adequate isolation.
- ••No history of previous endodontic therapy.
- ••No history of trauma to the involved tooth.
排除标准
- •Patients who have a positive history of analgesic intake within past 3 days.
- •Patients with periapical lesion.
- •Patients who have a positive history of antibiotics intake in the last month.
- ••Patients with known history of allergy to the drugs in study.
- ••Diabetic, immunocompromised patients, pregnant, lactating females.
- ••Calcified roots.
- ••Neurologic patients.
- ••Psychiatric patients who are not able to rate the pain on scale.
结局指标
主要结局
To assess the effect of combination of Ibuprofen (400 mg) and Paracetamol/Acetaminophen(325 mg) on Electric pulp testing and cold test
时间窗: at intervals of 20 minutes, 40 minutes,60 minutes
次要结局
- To assess the effect of Ketorolac tromethamine (20 mg) on Electric pulp testing and cold test(at intervals of 20 minutes, 40 minutes,60 minutes)
- To compare the effect of Ibuprofen (400 mg) and Paracetamol/Acetaminophen(325 mg), Ketorolac tromethamine(20mg) on cold test and Electric pulp testing(at intervals of 20 minutes, 40 minutes,60 minutes)
- o identify an analgesic that is more effective for pain relief during diagnostic tests(at intervals of 20 minutes, 40 minutes,60 minutes)
研究者
Dr Vaishnavi
SGT University