Effects of Antibiotic-Prepared Platelet-Rich Fibrin on Postoperative Recovery After Mandibular Third Molar Surgery: A Randomized Split-Mouth Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Incidence of postoperative infection
研究概览
简要总结
The present study aims to evaluate the effect of platelet-rich fibrin (PRF) used as a local antibiotic delivery vehicle on postoperative outcomes, including facial swelling, trismus, and pain, following mandibular third molar surgery in a randomized split-mouth clinical trial.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 交叉
- 主要目的
- 治疗
- 盲法
- 三盲 (受试者、研究者、结局评估者)
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
- Healthy patients (ASA I) according to the American Society of Anesthesiologists classification.
- Age 18-32 years.
- Ability to provide written informed consent.
- Bilateral mandibular third molars requiring extraction for prophylactic, therapeutic, or strategic reasons.
- Complete root development of mandibular third molars (Shumaker Stage H).
- Availability of diagnostic-quality CBCT scans with adequate field of view (17 × 20).
- Mandibular third molars classified as having conventional or moderate surgical difficulty according to Juodzbalys and Daugela classification.
排除标准
- Known allergy to corticosteroids.
- Immunosuppression or immunocompromised conditions.
- Acute infection at the mandibular third molar extraction sites.
- Current or previous intravenous amino-bisphosphonate therapy.
- Psychiatric disorders.
- Thrombocytopenia (platelet count <40,000/µL), thrombocytosis, or other coagulation disorders.
- Severe hepatic cirrhosis, advanced chronic renal failure, or uncontrolled -diabetes mellitus.
- Pregnancy or breastfeeding.
- Requirement for additional regenerative procedures (e.g., bone grafting).
- Localized facial malformations involving the cheek region.
研究组 & 干预措施
Test Group - Antibiotic and PRF
Participants will receive platelet-rich fibrin prepared with the addition of antibiotic prior to centrifugation. The antibiotic-enriched PRF clot will be placed into the mandibular third molar extraction socket to provide local antibiotic delivery at the surgical site.
干预措施: Antibiotic-enriched Platelet-Rich Fibrin (PRF) (Biological)
Control Group - PRF only
Participants will receive standard platelet-rich fibrin prepared without antibiotic addition. The PRF clot will be placed into the mandibular third molar extraction socket according to the same surgical protocol.
干预措施: Platelet-Rich Fibrin (PRF) (Biological)
结局指标
主要结局
Incidence of postoperative infection
时间窗: Up to 7 days after surgery
Occurrence of postoperative infection following mandibular third molar surgery, assessed through clinical examination based on the presence of signs and symptoms of infection (e.g., purulent discharge, erythema, fever, or need for additional antibiotic therapy).
Facial swelling quantitative analysis - volumetric differences
时间窗: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
To compare postoperative facial swelling between treatment groups using quantitative three-dimensional analysis based on volumetric differences. Facial volume changes will be measured in cubic centimeters (cm³) through three-dimensional facial scan superimposition.
Facial swelling quantitative analysis - linear differences
时间窗: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
To compare postoperative facial swelling between treatment groups using quantitative three-dimensional analysis based on linear measurements. Facial changes will be assessed by evaluating linear differences (mm) between preoperative and postoperative three-dimensional facial scans.
Facial swelling qualitative analysis
时间窗: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
Change in facial volume from baseline, assessed by three-dimensional facial scan superimposition and expressed as colorimetric variation between the preoperative and postoperative scans.
次要结局
- Trismus analysis(Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery)
- Pain analysis 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
研究点 (1)
标识符
- NCT 编号
- NCT07764757
- 其他研究编号
- 23/2023
日期
- 首次提交
- (上个月)
- 首次发布
- (上个月)
- 主要完成日期
- (29天前)
- 研究完成日期
- (下个月)
- 最近核实
- (3个月前)
- 最近更新
- (上个月)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否