Comparing Trypsin-Chymotrypsin and Naproxen Sodium for Post-endodontic Treatment Pain: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in post-endodontic treatment pain score using Numeric Rating Scale
研究概览
简要总结
This study aims to compare the pain reduction efficacy of Trypsin-Chymotrypsin and Naproxen sodium after root canal treatment in patients with symptomatic irreversible pulpitis. A lot of patients suffer greatly from post endodontic treatment pain and have a fear of dental treatments due to the pain. Patients refuse to go to the dentists and neglect oral hygiene care. That's why it is very important to find an effective drug regimen to reduce this post treatment pain. The null hypothesis is that there will be no difference between the efficacy and mean pain scores of Trypsin-chymotrypsin and Naproxen Sodium for post-endodontic treatment pain. Conducted as a triple-blinded, parallel, randomized controlled trial, 100 patients will be randomly assigned to receive either Trypsin-Chymotrypsin or Naproxen sodium following standard root canal therapy. Pain levels will be assessed using a numerical rating scale at 1, 6, 12, and 24 hours post-treatment to evaluate the effectiveness of these two pain management modalities.
详细描述
i. Background Prevention or management of pain, especially after root canal treatment, is of utmost importance to Endodontists. Non-steroidal anti-inflammatory drugs (NSAIDs) have been the most commonly used pain reduction modality in cases of irreversible pulpitis, but they do come with certain demerits. A lot of other alternatives have been researched as better alternatives for NSAIDs. Trypsin- Chymotrypsin has been proven to be an effective pain reducer after endodontic therapy.
ii. Objective The objective of this study is to compare the pain reduction efficacy of Trypsin- Chymotrypsin and Naproxen sodium after root canal treatment.
iii. Methodology In this triple-blinded, parallel, randomized controlled trial, a total of 100 patients will be included who are coming to the Operative Dentistry department for root canal treatment for any tooth. The patient must have a history of symptomatic irreversible pulpitis. The patients will be randomly allocated into two groups. One group (n = 50 will be the Trypsin- Chymotrypsin group, and the second group (n = 50) will be the Naproxen sodium group (active control group). The root canal treatment will be performed as usual. The first group will receive Trypsin- Chymotrypsin 1:100000 and the second group will receive Naproxen Sodium 550mg in sealed envelopes. The intensity of post-operative pain will be evaluated using a numerical rating scale at 1 hour, 6 hours, 12 hours, and 24 hour intervals.
iv. Sequence Generation: Computer generated randomization using appropriate software (random.org) to assign the participants to trypsin-chymotrypsin or naproxen sodium group, ensuring a complete random allocation to each treatment arm, decreasing a risk of bias and enhancing the internal validity of the study.
v. Blinding: The participants, researcher and outcome assessors will be blinded in this research (triple blinded).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Both male and female, healthy patients (ASA class 1).
- •Patients between the age group of 18-45 years.
- •Patients who are appointed for endodontic treatment.
- •Maxillary or mandibular teeth diagnosed with symptomatic irreversible pulpitis based on delayed responses to vitality tests.
排除标准
- •Patients who will require emergency dental treatment.
- •Teeth with any form of peri-apical lesion will be excluded.
- •Patient who have taken analgesics within 24 hours prior to the treatment.
- •Patients with known hypersensitivity or allergy to any of the study medications.
- •Patients with any systemic disease such as uncontrolled diabetes, gastric ulcers, bleeding disorders, or cardiovascular problems.
- •Pregnant or lactating women and pediatric patients.
研究组 & 干预措施
Trypsin-Chymotrypsin
This group will receive sealed envelopes containing oral formulations of Trypsin:Chymotryspin in the ratio of 6:1 with an enzymatic activity of 100000 A.U./tablet (Tab. Chymoral Forte) three times a day, 30 minutes before meals for 24 hours.
干预措施: Trypsin-Chymotrypsin (Drug)
Naproxen Sodium
The active control group will receive oral formulation of Naproxen Sodium 550mg (Tab. Synflex) twice a day, after meals for 24 hours.
干预措施: Naproxen Sodium 550mg (Drug)
结局指标
主要结局
Change in post-endodontic treatment pain score using Numeric Rating Scale
时间窗: 24 hours
The Numeric Rating Scale (NRS-11) is an eleven-point scale that ranges from 0, indicating no pain, to 10, representing the most severe pain the patient has ever encountered.
次要结局
未报告次要终点
研究者
Hafsa Zaki
Principal Investigator
Dow University of Health Sciences