Influence of Serotonin and Kynurenic Acid on Postoperative Pain, Neuroinflammation and Anxiety Following Surgical Removal of Impacted Mandibular Third Molars
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
A prospective cohort of 40 consecutive patients with bilateral impacted mandibular third molars underwent two sequential surgical extractions separated by a two-week interval. Serum kynurenic acid (KYNA) and serotonin were measured preoperatively and 24 hours after each procedure. The study examined longitudinal dynamics of kynurenine pathway biomarkers, their variation across Pederson surgical difficulty grades, and their relationship with postoperative pain and state anxiety.
详细描述
Participants were randomised to placebo, ibuprofen 400 mg, or ibuprofen 400 mg plus gabapentin 300 mg administered preemptively 1 hour before incision and continued at 8-hourly intervals for 24 hours. Blood samples were collected at four timepoints (T0 Op1, T24 Op1, T0 Op2, T24 Op2) and analysed by ELISA for serum KYNA and serotonin. Postoperative pain was assessed by VAS at 2, 6, 12, 24, 48, and 72 hours. State-trait anxiety was assessed using the STAI Form Y before each operation. Pederson difficulty index was applied independently by two calibrated examiners. The biomarker analysis is reported observationally with pharmacological allocation treated as a covariate. Clinical data and samples were collected at the Department of Oral Surgery, Faculty of Dental Medicine, Medical University of Plovdiv, Bulgaria, during 2017-2018; laboratory biomarker analyses were conducted under Project No. DPDT-12/2019, Medical University of Plovdiv, and completed in 2020.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind achieved using identical-appearing capsules. Biochemical analyses performed blinded to surgical timepoint and pharmacological group allocation.
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Bilateral impacted mandibular third molars requiring surgical extraction
- •Age 18-38 years
- •Written informed consent
- •Ability to comply with study procedures
排除标准
- •Systemic inflammatory disease
- •Autoimmune disease
- •Neurological disease
- •Psychiatric disorders
- •Chronic pain conditions
- •Use of immunomodulatory medications
- •Use of psychotropic medications
- •Use of analgesic medications
- •Pregnancy
- •Drug hypersensitivity
- •Active pericoronitis at enrollment
研究组 & 干预措施
Ibuprofen + Gabapentin
Ibuprofen 400 mg plus Gabapentin 300 mg oral capsules administered 1 hour before incision, repeated every 8 hours for 24 hours. N=15
干预措施: Ibuprofen + Gabapentin (Drug)
Placebo
Identical-appearing capsules administered 1 hour before incision, repeated every 8 hours for 24 hours. N=10.
干预措施: Placebo (Drug)
Ibuprofen
Ibuprofen 400 mg oral capsules administered 1 hour before incision, repeated every 8 hours for 24 hours. N=15
干预措施: Ibuprofen (Drug)
研究者
Deyan Neychev
Associate Professor
Plovdiv Medical University