Comparative evaluation of efficacy of ketoprofen and diclofenac transdermal patch in the management of postoperative pain following periodontal flap surgery - A Split mouth, Randomized Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- To compare and evaluate the efficacy of Ketoprofen and Diclofenac transdermal patch in the management of postoperative pain following periodontal flap surgery.
研究概览
简要总结
Periodontal diseases are inflammatory disorders that cause progressive bone loss and eventually loss of teeth and supporting structures. Periodontal surgery aims to eliminate causative agents to arrest inflammation, but successful treatment also requires proper control of postoperative pain, which is one of the most common complications. Effective pain management is essential for patient comfort and compliance.
Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used for pain control in dentistry. Commonly prescribed agents include paracetamol, aspirin, diclofenac sodium, ketoprofen, and ibuprofen. These drugs are administered through various routes such as oral, parenteral, nasal, or transdermal. However, oral administration has limitations—mainly first-pass metabolism, which reduces drug bioavailability to nearly 50%, and difficulties in patients with physical or mental disabilities.
Transdermal drug delivery offers several advantages over oral administration. It bypasses first-pass metabolism, allows sustained and controlled absorption, maintains stable plasma concentration, avoids gastrointestinal discomfort, and enables simple discontinuation by removing the patch. This system has recently gained popularity as it can deliver drugs either locally to adjacent tissues or systemically via the circulation.
Transdermal patches, or medicated adhesive skin patches, provide a convenient, non-invasive method of drug administration. They ensure controlled drug release, minimize fluctuations in plasma levels, and reduce side effects commonly associated with oral therapy.
Ketoprofen, an aryl-propionic acid derivative, acts by non-selective inhibition of COX-1 and COX-2 enzymes, reducing prostaglandin synthesis and producing analgesic and anti-inflammatory effects. Diclofenac, an aryl-acetic acid derivative, shows relative selectivity for COX-2 inhibition, also suppressing prostaglandin production and providing similar benefits. Both drugs have proven oral efficacy, and their formulation as transdermal patches may enhance analgesic effectiveness with fewer systemic drawbacks.
This study focuses on evaluating ketoprofen and diclofenac in transdermal delivery systems for postoperative pain management in periodontal surgery, reflecting the evolving role of skin-based drug administration in dentistry and its promising future applications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 25.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Systemically healthy patient.
- •Patient age ranging 25-60 years.
- •Periodontal pocket depth more than or equal to 5mm.
- •Patient requiring at least 2 quadrants for flap surgery.
- •Patients with good oral hygiene after scaling and root planning.
- •Presence of at least 20 natural teeth.
- •Patient willing to participate in the study.
排除标准
- •The patients who are undergoing treatment with analgesics or corticosteroids during the trial period.
- •Pregnancy and lactating mothers.
- •Smokers and alcoholic.
- •Patients with cardiovascular disease.
- •Patients with gastrointestinal bleeding or ulcers.
- •Patients with liver diseases.
- •Patients with kidney diseases.
- •Patient allergic to Diclofenac and Ketoprofen.
结局指标
主要结局
To compare and evaluate the efficacy of Ketoprofen and Diclofenac transdermal patch in the management of postoperative pain following periodontal flap surgery.
时间窗: Every hour upto 8hours
次要结局
- 1)To evaluate the efficacy of Diclofenac transdermal patch in reducing postoperative pain following periodontology flap surgery.(2)To evaluate the efficacy of Ketoprofen transdermal patch in reducing postoperative pain following periodontology flap surgery.)
研究者
Jaswanth sanam G
KVG Dental College and Hospital
