Evaluation of the Effects of Dexamethasone-Enriched Platelet-Rich Fibrin on Postoperative Pain, Edema, and Trismus Following Impacted Mandibular Third Molar Surgery: A Randomized Split-Mouth Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Postoperative Pain and Analgesic Consumption
研究概览
简要总结
Brief Summary
This clinical trial investigates the effects of platelet-rich fibrin (PRF) derived from dexamethasone-enriched blood on postoperative recovery following the surgical extraction of impacted mandibular third molars (wisdom teeth). The study aims to determine whether the addition of dexamethasone, a potent anti-inflammatory medication, to the blood used for PRF preparation can reduce postoperative pain, swelling, and limited mouth opening (trismus) more effectively than standard PRF.
The study is designed as a randomized, split-mouth, double-blind clinical trial involving 16 patients who require bilateral extraction of impacted lower third molars. Each patient receives both treatments: one extraction socket treated with standard PRF and the other with dexamethasone-enriched PRF. Postoperative outcomes including pain intensity, edema, trismus, and analgesic consumption are recorded and analyzed.
The results of this study could offer a safer and more effective method for managing discomfort after wisdom tooth removal, potentially improving patient quality of life and reducing the need for additional medications.
详细描述
Detailed Description
Background:
Third molar (wisdom tooth) extraction is a common oral surgical procedure often associated with postoperative inflammatory complications such as pain, edema, and trismus, which can significantly reduce patient quality of life. Platelet-rich fibrin (PRF) has been used to enhance healing and reduce postoperative morbidity. Dexamethasone is a corticosteroid known for its potent anti-inflammatory effects. This study evaluates whether PRF prepared from dexamethasone-enriched blood can improve postoperative outcomes compared to standard PRF.
Objectives:
The primary objective is to assess the effect of dexamethasone-enriched PRF on postoperative pain following impacted mandibular third molar extraction. Secondary objectives include evaluation of edema, trismus, and analgesic consumption.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Both participants and clinicians performing postoperative evaluations were blinded to the treatment allocation. This was done to minimize bias in reporting and assessment of postoperative pain, edema, and trismus.
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged between 18 and 25 years.
- •Presence of bilateral, symmetrical, bone-retained impacted mandibular third molars requiring extraction.
- •Systemically healthy individuals with no chronic medical conditions.
- •Good oral hygiene and healthy periodontal status.
- •Radiographically confirmed bilateral similarity of impacted third molars.
- •Patients willing to participate and who provided written informed consent.
排除标准
- •Presence of systemic diseases or conditions that may affect wound healing.
- •Regular use of prescription medications.
- •Pregnant or lactating individuals, or those with suspected pregnancy.
- •Known allergy or hypersensitivity to dexamethasone or related compounds.
- •Poor oral hygiene or active periodontal disease.
- •Presence of fungal, viral, or bacterial infection either systemically or locally.
- •History of corticosteroid use within the past month.
- •Temporomandibular joint disorders affecting mouth opening.
研究组 & 干预措施
Test - Dexamethasone-enriched PRF
Application of platelet-rich fibrin (PRF) prepared from blood enriched with 4 mg dexamethasone to the mandibular third molar extraction site.
干预措施: Platelet-rich fibrin (PRF) (Procedure)
Control - Standard PRF
Application of standard platelet-rich fibrin (PRF) prepared from blood without dexamethasone to the mandibular third molar extraction site.
干预措施: Platelet-rich fibrin (PRF) (Procedure)
结局指标
主要结局
Postoperative Pain and Analgesic Consumption
时间窗: 72 hours post-surgery
Measurement of postoperative pain using the Visual Analog Scale (VAS; range 0-10, where 0 indicates no pain and 10 indicates the worst imaginable pain) and total analgesic intake at 24, 48, and 72 hours after mandibular third molar extraction.
Postoperative Pain and Analgesic Consumption
时间窗: 72 hours post-surgery
Measurement of postoperative pain using the Visual Analog Scale (VAS; range 0-10, where 0 indicates no pain and 10 indicates the worst imaginable pain) and total analgesic intake at 24, 48, and 72 hours after mandibular third molar extraction.
次要结局
- Postoperative Trismus(Postoperative days 1, 3, and 7)
- Postoperative Facial Edema(Postoperative days 1, 3, and 7)
- Postoperative Facial Edema(Postoperative days 1, 3, and 7)
- Postoperative Trismus(Postoperative days 1, 3, and 7)
研究者
Muhammet Caner Dere
PhD
Cumhuriyet University