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临床试验/NCT05941130
NCT05941130招募中4 期

Three-dimensional Evaluation of Postoperative Edema After Third Molar Surgery: a Randomized Clinical Trial

Implantology Institute1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Facial swelling

研究概览

简要总结

Surgical removal of third molars is recognized as one of the most frequent procedures performed in oral surgery. Literature is rich in studies attempting to demonstrate the benefit of corticosteroids in third molar surgery, however the variety of methods, doses, routes and timing of administration has hampered the standardization of their use in light of best evidence. Also the use of 3D facial superimposition methodology to measure and analyze facial swelling after third molar surgery is a relatively new and promising technology.

详细描述

Surgical removal of third molars is recognized as one of the most frequent procedures performed in oral surgery. It is estimated that more than 50% of the population experience problems with their third molars, including impaction or other pathologies. Usually, recovery from third molar surgical procedures is straightforward, however some immediate side effects can be expected such as discomfort (pain), edema and trismus that are resolved within a few days. These results from postoperative tissue inflammatory response which present individual variations. Depending on the intensity of these postoperative symptoms and the severity of inflammatory response, daily activities may be temporarily affected and patient's overall quality of life might be impaired.

Factors as surgical technique, type of impaction, duration of the procedure, surgical complications and an inadequate pharmacotherapy may influence the severity of symptoms. Although edema and discomfort after the surgery cannot be completely eliminated, the possibility of reducing the frequency and severity of complications and improve patient's quality of life have been investigated.

Synthetic corticosteroids are widely used in surgery to control and reduce the post-surgical inflammatory response and pain since they limit inflammation and edema by reducing vascular dilatation and fluids transudation Literature is rich in studies attempting to demonstrate the benefit of corticosteroids in third molar surgery, however the variety of methods, doses, routes and timing of administration has hampered the standardization of their use in light of best evidence. To maximize the effectiveness in controlling both pain and swelling it is described in literature the combination of both NSAID and corticosteroids after third molar surgery, nevertheless reluctance and controversy regarding their coadministration in oral surgery still exists.

The use of 3D facial superimposition methodology to measure and analyze facial swelling after third molar surgery is a relatively new and promising technology that allows a high level of accuracy and a quantitative analysis of this outcome having a great potential to become the standard method for evaluating volumes and distances in facial and body anatomy.

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 (Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Individuals requiring surgical extraction of fully or partially impacted third molars requiring osteotomy;
  • Individuals classified as grade I or II of the American Society of Anesthesiologists (ASA)
  • Individuals with compliance to cooperate with the research protoco

排除标准

  • Individuals with active bleeding or coagulation disorders
  • Individuals with history of intolerance or hypersensitivity to the drugs included in the postoperative medication protocol
  • Pregnant or lactating women
  • Individuals with cysts or tumors around the embedded third molar
  • Individuals who did not attend the control visits.

研究组 & 干预措施

Group A

Experimental

Patients assigned into group A (NSAID) will receive only Ibuprofen 600mg (Mylan)

干预措施: Non-steroidal anti-inflammatory therapy (Ibuprofen 600mg Mylan) (Drug)

Group B

Experimental

Patients assigned into group B (CORT + NSAID) will receive Ibuprofen 600mg (Mylan) with methylprednisolone (Medrol, 16mg Pfizer Laboratories)

干预措施: Combination of corticosteroid (methylprednisolone - Medrol, 16mg Pfizer Laboratories) therapy and non-steroidal anti-inflammatory (Ibuprofen 600mg Mylan) therapy (Drug)

结局指标

主要结局

Facial swelling

时间窗: 7 postoperative days

To evaluate postoperative facial swelling after impacted third molar surgery by using a 3D facial scanner in two different groups: A-NSAID alone; B - corticosteroid + NSAID. Each patient will perform three sets of facial soft tissue evaluation: before surgery (t0); 2 days postoperatively (t2) and 7 days postoperatively (t7). The changes in facial soft tissue volume after surgery will be qualitatively and volumetrically evaluated by using the previously validated 3D assessment with a 3D facial scanner (Bellus3D, version 2.2.1; Inc. Los Gatos, CA, USA) connected to a smartphone (Xiaomi Mi A2 Lite, Android version 9) via USB. Facial swelling will be determined by quantifying volumetric changes by using the superposition methodology and the alignment by the best fit algorithm of the pre and postoperative images, with Geomagic® software (Geomagic Inc., North Carolina, USA)

次要结局

  • Postoperative Pain(7 postoperative days)
  • Patient's quality of life(7 postoperative days)

研究者

发起方
Implantology Institute
申办方类型
Other
责任方
Sponsor

研究点 (1)

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