Three-dimensional Facial Swelling Evaluation of Pre-operative Single-dose of Prednisone in Third Molar Surgery: a Split-mouth Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change in facial swelling
研究概览
简要总结
The present study proposes to compare the effect of a single preoperative dose of prednisone versus placebo in terms of facial swelling, trismus and pain after surgical removal of the mandibular third molar (M3M) in a split-mouth randomized controlled clinical trial.
详细描述
This study aims to compare the effect of a single preoperative dose of prednisone versus placebo in terms of facial swelling, trismus, and pain after surgical removal of M3M in a split-mouth randomized controlled clinical trial. Facial swelling will be evaluated using an innovative three-dimensional digital technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 32 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18 to 32 years who required both M3M extractions were recruited
- •Good health status
- •Indication to surgical extraction of both M3M
- •Complete root formation
- •Surgical risk level classified as "Conventional" or "Moderate" according to Daugela et al. classification
排除标准
- •Person under the age of 18 or over 32
- •Allergy or contraindications to administration of corticosteroids
- •Acute infection in any of the teeth to be extracted
- •Patients with chronic liver disease, diabetes, immune system dysfunction, or haematological disease
- •Pregnancy or breastfeeding
- •History of treatment with antiresorptive drugs
- •Chronic kidney disease
- •History of systemic corticosteroid therapy in the past 4 weeks
研究组 & 干预措施
Prednisone group (PG)
Patients receiving a preoperative administration of prednisone 25 mg/os.
干预措施: Prednisone (Drug)
Control group (CG)
Patients receiving a preoperative administration of Placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in facial swelling
时间窗: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
To compare the effectiveness of prednisone/os versus placebo in reducing facial swelling using quantitative three-dimensional analysis (differences are measured in cm3).
次要结局
- Change in trismus(Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery)
- Change in pain with Visual analogue scale (VAS)(Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery)
研究者
Amerigo Giudice
Professor
University Magna Graecia