Effect of Hyaluronic Acid on the Therapy of Alveolar Osteitis - A Double-blind, Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Pain perception by the patient
研究概览
简要总结
Alveolar osteitis (AO; syn. dry socket) is one of the most frequent complications following tooth removal and it is defined as presence of severe postoperative pain in and around the extraction site, which increases in severity at any time between one and three days after extraction, accompanied by a partially or completely disintegrated blood cloth within the alveolar socket, with or without halitosis, and at the same time excluding any other cause for the pain (Blum 2002). To enhance standard treatment of AO, which consists of curettage of the dry socket, rinsing with saline solution, and inducing bleeding from the exposed alveolar bone walls, numerous products have been tested. One of them is hyaluronic acid (HY). The aim of the present study is to investigate the potential effect of HY gel application in the treatment of AO. Specifically, the application of HY only (HY test group; n = 20) or the combination of HY and an absorbable collagen sponge (HY+C test group; n = 20) will be compared to standard treatment (blood clot; control group, n=20). Clinical and patient related outcome parameters will be recorded for up to 14 days after treatment. A more stable blood clot and thus improved wound healing with faster pain reduction is expected through the use of HY.
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 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 years;
- •Untreated AO after extraction of a permanent tooth (excluding wisdom teeth);
- •Diagnosis of AO based on the criteria of Blum (Blum 2002)
排除标准
- •Patients with chronic diseases and/or taking any medication, influencing hard and soft tissue healing;
- •History of hypersensitivity or allergy to HY;
- •Inability to attend follow-up appointments; Intake of preoperative antibiotics.
结局指标
主要结局
Pain perception by the patient
时间窗: 2 weeks
VAS- Visual analogue scale measured on a 10cm scale, where 0 represents no pain and 10 represents maximum pain
次要结局
未报告次要终点
研究者
Danijel Domic DMD
Dental medical doctor
Medical University of Vienna
