跳至主要内容
临床试验/NCT04869306
NCT04869306Unknown不适用

Effect of Hyaluronic Acid on Early and Late Tissue Healing After Removal of Impacted Mandibular Third Molars - 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 102 人开始时间: 2021年11月29日最近更新:
适应症

试验速览

阶段
不适用
入组人数
102
试验地点
2
主要终点
Probing depth at adjacent second molar

研究概览

简要总结

Hyaluronic acid (HY) is used in dentistry to improve wound healing after oral and periodontal surgical interventions. After the application of HY, a positive effect on the wound healing of extraction sockets and periodontal defects has been described. The removal of a mandibular wisdom tooth (LM3) often leads to remaining residual defects with increased probing depths distal to the second molar. To date, the influence of HY on periodontal healing of the distal aspect of the second molar after removal of the LM3 has not yet been investigated. Accordingly, the aim of this double-blind, controlled and randomized clinical study is the influence of the application of HY Gel or HY Gel in combination with an absorbable collagen sponge on the periodontal healing of the second molar after surgical removal of the LM3 compared to the standard procedure (blood clot). A total of 102 patients with an impacted LM3 and a pre-existing bone defect of at least 5 mm distal to the second molar will be included. In the HY test group (n = 34), HY gel is applied to the LM3 extraction socket, and in the HY + C test group (n = 34) HY gel and an absorbable collagen sponge, while the control group (n = 34) does not receive any additional treatment. Patients are followed up for 12 months and the presence of an increased probing depth (≥ 5mm) on the distal side of the second molar is defined as the main parameter. A more stable blood clot and thus improved wound healing including periodontal healing 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

  • Patients elder than 18 years;
  • uni- or bilateral vertical or mesioangular complete impaction of the LM3 classified to:
  • group II- or III- B or C according to Pell-Gregory (1933);
  • a distance ≥ 5 mm from the CEJ to marginal bone level at the distal aspect of the second molar.

排除标准

  • Patients with chronic diseases and/or
  • taking any medication, influencing hard and soft tissue healing;
  • acute pain/infection of the surgical region;
  • untreated periodontal disease;
  • patients smoking > 10 cigarettes per day;
  • history of hypersensitivity or allergy to HY;
  • absence of an adjacent second molar;
  • presence of caries or restoration on the distal aspect of the adjacent second molar; and
  • inability to attend the follow-up appointments.

结局指标

主要结局

Probing depth at adjacent second molar

时间窗: 1 year

Probing depth will be measured from the gingival margin to the bottom of the periodontal pocket measured in mm with a graduated periodontal probe at disco-buccal, distal and disco-lingual aspect of the second molar

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)

Loading locations...

相似试验