Comparative Evaluation of Two Different Drugs Administered Using Transdermal Drug Delivery Route Versus Two Oral Tablets in Management of Post-Endodontic Pain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
研究概览
简要总结
This clinical trial evaluated whether two drugs delivered through transdermal drug delivery systems reduced post-endodontic pain as effectively as two orally administered medications in adult patients undergoing root canal treatment. The study also compared how effectively these medications controlled pain during the first 48 hours after treatment.
The study aimed to answer the following questions:
Did transdermal drug delivery systems provide pain relief comparable to or better than orally administered medications after endodontic treatment? Did pain intensity differ among the four treatment groups as measured using the Visual Analog Scale (VAS)?
The investigators compared two transdermal drug groups with two oral drug groups to identify the treatment that provided better control of post-endodontic pain.
Participants:
Underwent root canal treatment for symptomatic irreversible pulpitis. Received one of four analgesic interventions consisting of two transdermal patches or two oral medications.
Recorded pain intensity using the Visual Analog Scale (VAS) at 6, 12, 24, and 48 hours after treatment.
详细描述
Post-endodontic pain is a common consequence of root canal treatment and is primarily associated with the release of inflammatory mediators in the periapical tissues following instrumentation and obturation. Analgesic medications are routinely prescribed to reduce pain during the immediate postoperative period. Conventional oral administration is effective but may be associated with gastrointestinal adverse effects and variability in drug absorption. Transdermal drug delivery systems provide sustained release of medication through the skin, maintain relatively stable plasma concentrations, and may improve patient compliance while reducing systemic adverse effects.
This randomized, parallel-group clinical trial was conducted to compare the effectiveness of two transdermal medications, fentanyl patch and ketoprofen patch, with two orally administered medications, diclofenac and ibuprofen, in the management of post-endodontic pain. A total of 80 participants undergoing single-sitting root canal treatment were enrolled and randomly allocated into four equal groups of 20 participants each.
Participants in Group I received a transdermal fentanyl patch; Group II received a transdermal ketoprofen patch; Group III received oral diclofenac tablets; and Group IV received oral ibuprofen tablets according to the study protocol. All interventions were administered after completion of endodontic treatment.
The study was designed to determine whether transdermal administration of analgesic agents could provide pain control comparable to or better than conventional oral therapy during the early postoperative period following root canal treatment. The findings were intended to contribute to evidence-based recommendations regarding alternative routes of analgesic administration for the management of post-endodontic pain in clinical endodontic practice.
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
- None
盲法说明
Although the study was open-label due to differences in intervention forms, outcome assessment at 48 hours was conducted via telephone by an assessor blinded to treatment allocation using standardized pain scoring methods.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 60 years
- •Patients diagnosed with symptomatic irreversible pulpitis or symptomatic apical periodontitis
- •Multi-rooted teeth indicated for single-visit root canal treatment
- •Patients experiencing moderate to severe preoperative pain
- •Systemically healthy individuals
- •Patients willing to participate and comply with follow up protocol
排除标准
- •Patients with a known history of hypersensitivity or adverse reactions to diclofenac, ketoprofen, or other non-steroidal anti-inflammatory drugs (NSAIDs), including reactions such as bronchospasm, shock, or urticaria, were excluded from the study.
- •Individuals with a history of active gastric or duodenal ulceration within the previous six months were not included.
- •Patients who were currently receiving NSAIDs or corticosteroid therapy during the study period were excluded.
- •Participants with a medical history of systemic conditions such as bronchial asthma, epilepsy, inflammatory bowel disease, severe hepatic or renal impairment, dengue fever, or any psychological or psychiatric disorders were not considered eligible for inclusion.
- •Pregnant and lactating women were excluded from the study.
- •Patients with a history of antibiotic use during the study period were also excluded.
研究者
Dr Chitra Kumari
Postgraduate Student
Nims University Rajasthan