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临床试验/NCT04853589
NCT04853589Unknown不适用

Effect of Hyaluronic Acid on the Therapy of Alveolar Osteitis - A Double-blind, Randomized Controlled Clinical Trial

Medical University of Vienna2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年5月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Danijel Domic DMD

Dental medical doctor

Medical University of Vienna

研究点 (2)

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