A Clinical Investigation of the Efficacy of Platelet Rich Fibrin (Bio-PRF) Compared to Alveogyl in the Treatment of Alveolar Osteitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Change in postoperative pain levels: Day 0 to Day 3
研究概览
简要总结
Alveolar osteitis, commonly referred to as dry socket, is a common painful postoperative complication following tooth extraction. It is defined as pain in and around an extraction socket which increases at any time between one and three days following extraction, accompanied by partial or total loss of the blood clot from the socket, with or without halitosis (Blum, 2002).
The incidence of the complication varies from 1-5% for routine extractions up to approximately 30% for third molar extractions. There are a variety of factors that contribute to the incidence of dry socket including tissue trauma, smoking in the early postoperative period and the oral contraceptive pill. Although it is a self- limiting condition, symptoms can be very debilitating for patients and therefore following diagnosis, immediate treatment should be provided to expedite resolution and to their improve quality of life during the healing period. Treatment options for dry socket vary from rinsing of the socket, regular analgesia and sometimes placement of an obtundent, sedative dressing such as Alveogyl or a zinc oxide eugenol alternative.
This study will aim to compare two treatments for patients who present with alveolar osteitis (dry socket) to Dublin Dental University Hospital after tooth extraction. Following randomisation, one of two treatment modalities will be used, either a experimental treatment (Bio-PRF) or a positive control (Alveogyl).
The results of this study will enable us to learn more about the efficacy of these treatment options for dry socket and how they affect patients.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and females adults at least 18 years old
- •A diagnosis of alveolar osteitis following tooth extraction based on patients having both pain and exposed bone
- •Good command of the English language
- •Willingness to keep a diary of symptoms and travel for the review appointment on day 7 following intervention
排除标准
- •Pregnant or breastfeeding women
- •Current or previous bisphosphonate used or history of radiotherapy to the jaws
- •Allergy or intolerance to study materials
- •Lack of capacity to consent to participate in the study
研究组 & 干预措施
Bio-PRF
This is a blood-derived platelet rich concentrate from the patient's whole blood sample. The patient typically donates two 9ml (1.5 tablespoons) vials of blood that is then spun in a centrifuge.
干预措施: Bio-PRF (Biological)
Alveogyl
Alveogyl is an intraalveolar sedative, obtundent dressing, which contains the active ingredient eugenol.
干预措施: Alveogyl (Drug)
结局指标
主要结局
Change in postoperative pain levels: Day 0 to Day 3
时间窗: Day 3 following intervention
Pain will be measured using a pain diary with VAS scale (0-100) at baseline and Day 3. The changes in patient pain levels from baseline will be compared to Day 3 for each group.
Change in postoperative pain levels: Day 0 to Day 7
时间窗: Day 7 following intervention
Pain will be measured using a pain diary with VAS scale (0-100) at baseline and Day 7. The changes in patient pain levels from baseline will be compared to Day 7 for each group.
次要结局
- Quality of Life Measurements (QoL)(Day 7 following intervention)
- Healing(Day 7 following intervention)
研究者
Maeve Cooney
Postgraduate Student in Oral Surgery
University of Dublin, Trinity College
