The Effect of Platelet-rich Fibrin on Clinical and Patient-centered Outcomes of Third Molar Extractions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change in Swelling
研究概览
简要总结
The fear of oral surgeries is mostly dedicated to pain and swelling in the following days. It is not surprising, that it is of high interest to do anything to reduce these consequences. Maybe this is a reason, why using platelet concentrates in oral health rehabilitation has become common in the last couple of years. Less swelling, less pain, quicker healing. The aims of the present study are to determine the effect of a platelet rich fibrin on postsurgical inflammatory complications and patient-centred outcomes and perceptions, in patients undergoing third molar extractions by split mouth technique.
25 medically healthy adults will be assigned to one of 2 groups (1 test- and 1 control group). This means due to the split mouth technique patients undergo a third molar extraction twice. The first time the patient will be randomly assigned to the test- or control group and the second time the patient will be in the other group (test or control group).
The test groups socket will be filled with a PRF (platelet-rich fibrin)-Clot before suturing the wound during third molar surgery. As well, a blood count and coagulations values will be determined. The control group will be operated conventionally. Swelling will be measured at day 1, 3 and 7 post surgery by CBCT (cone-beam computed tomography) facial scan. Subjects will be examined clinically by examiners at the seventh day after surgery for postoperative complications. In addition, Visual analogue scores (VAS) on pain, swelling and bleeding will be obtained from the patients from day 0 through day 7. The present study will answer an important clinical question with regards to the recommendation of platelet-rich fibrin usage to prevent post-operative complications with third molar surgery and to recommend a platelet-rich fibrin, if required.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medically healthy adult [ASA (American Society of Anesthesiologists) classification I-II], age ≥ 16 years old
- •Preferably non-smoker, or previous smoker (quit ≥ 5 years), light smoker with less than 20 cigarettes/ day
- •Therapeutic or strategic indications
- •No allergies against local anasthesia (Articain, Mepivacain) and their preservatives (Natriummetabisulfid E223, natriumchlorid)
- •Written consent of the patient
- •No infected upper and lower third molars
- •Third molars in 4 quadrants and located in maxilla/mandible (classification of Pell and Gregory/ Winter) and indication for extractions
排除标准
- •Medically compromised subjects (ASA classification III-V)
- •General contraindications against third molar extractions (e.g. immunodeficiency, advanced systemic diseases, corticosteroid medication)
- •Treatment or diseases that may have an effect on bone turnover or bone or non-mineralized tissue metabolism (e.g. Bisphosphonates or local radio-therapy)
- •Patients with anticoagulant therapy
- •Heavy smoker or previous heavy smoker (quit < 5 years; ≥ 20 cigarettes/day)
- •Use of any form of antibiotics in the last 3 months or subjects requiring antibiotic prophylaxis prior to dental treatment
- •Pregnant or breast feeding. Self declared intend to conceive. A pregnancy test performed for female patients.
- •Subjects aged < 16 years old
结局指标
主要结局
Change in Swelling
时间窗: Pre-surgical and at day 1, 3, 7 and 14 post-surgical
Buccal swelling will be measured manually as well as within creating a 3D face scan pre-surgical and at day 1, 3, 7 and 14 post-surgical. Scans will be superimposed and compared with Romexis software. Manual measurement: Lines between lateral corner of the eye- jaw angle, Tragus- outer Mouth corner, Tragus-Pogonion will be measured in mm and be compared pre-surgical and at day 1, 3, 7 and 14 post-surgical. longer lines suggest more swelling and a worse outcome.
次要结局
- Change in Inflammatory Complications - Amount of clinical recordings(Pre-surgical and at day 1, 3, 7 and 14 post-surgical)
- Change in Inflammatory Complications - VAS Swelling(Pre-surgical and at day 1, 3, 7 and 14 post-surgical)
- Change in Inflammatory Complications - VAS Pain(Pre-surgical and at day 1, 3, 7 and 14 post-surgical)
- Change in Inflammatory Complications - VAS Bleeding(Pre-surgical and at day 1, 3, 7 and 14 post-surgical)