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临床试验/NCT05253261
NCT05253261已完成不适用

Decompression of Odontogenic Cysts Using an Appliance Fabricated With a Fully Digital Workflow

Semmelweis University2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2021年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
Recurrence

研究概览

简要总结

The aim of this prospective case series is to present clinical results with cystostomy, decompression and final enucleation of odontogenic cysts using a decompression device fabricated with a full digital workflow and delivered on the day of cystostomy. The secondary purpose of our study is to present the volumetric changes of the odontogenic cysts treated by decompression.

详细描述

Cystostomy and decompression Patients rinse with 0.2% chlorhexidine solution for 1 min before surgery. Under local anesthesia, an envelope flap from marginal incision is elevated and teeth deemed for extraction are removed in an atraumatic manner. In those cases where the cyst may not be accessed from the sockets of the teeth removed osteotomies are carried out by round burs using a surgical handpiece (SURGmatic S11 L Pro , Kavo Dental, Brea, California, United States) and motor (MASTERsur LUX, Kavo Dental, Brea, California, United States) to create a bony window. A histological sample is collected from the cyst lining to confirm the initial diagnosis of odontogenic cyst. Wound margins are stabilized using single interrupted sutures. The decompression appliance is delivered in the same sitting. Patients are instructed on how to wear and clean their decompression device. Antibiotics (1 g amoxicillin-clavulanate twice a day for 5 days or, in case of side effects or known allergy to penicillin, 300 mg clindamycin 4 times a day for 4 days), non-steroid anti-inflammatory drugs (50 mg diclofenac 3 times a day for 3 days), and chlorhexidine mouthwash (twice a day for 21 days from the first day after surgery) are prescribed. Sutures are removed after 7 days

Postoperative imaging Postoperative CBCT examination is performed six months into the decompression period using the same scanning conditions as those used for the preoperative CBCT scan.

Data acquisition Pre- and postoperative CBCT reconstructions are registered by landmark registration using the 3DSlicer 4.10.2 (The Brigham and Women's Hospital, Inc., Boston, MA, USA) software. The volume of the odontogenic cysts before (Preoperative Volume) and following (Postoperative Volume) decompression are assessed by manual segmentation using the segment editor and segment statistics plug-in. Volume Reduction is calculated by subtracting the Postoperative Volume from the Preoperative Volume. Percentage of Volume Reduction is calculated as follows: Volume Reduction/Preoperative Volume X 100.

Decompression Decompression is maintained until the cyst reduces in volume to an extent, that enucleation may be performed with minimal risk of complications (damage to the anatomical landmarks blood vessels, nerves, roots of neighboring teeth, nasal cavity, maxillary sinuses). During the decompression period patients are recalled for clinical examination and radiographic control (panoramic radiographs) monthly.

Enucleation Following decompression enucleation of the remaining cyst is carried out under local anaesthesia.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
5 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of the Department of Community Dentistry, Semmelweis University, presenting with odontogenic cysts of the jaws that involved anatomical landmarks were included in the study.

排除标准

  • History of tumors or irradiation therapy in the head and neck region,
  • History of uncontrolled medical or psychiatric disorders,
  • Unwillingness to return for follow-up appointments.

研究组 & 干预措施

Odontogenic cyst treated by decompression with an appliance.

Experimental

Cystostomy procedure is carried out with the same day delivery of a decompression appliance fabricated with a fully digital workflow. Enucleation of the cyst is carried out following decompression.

干预措施: Preoperative Cone Beam Computed Tomography (CBCT) scan (Diagnostic Test)

Odontogenic cyst treated by decompression with an appliance.

Experimental

Cystostomy procedure is carried out with the same day delivery of a decompression appliance fabricated with a fully digital workflow. Enucleation of the cyst is carried out following decompression.

干预措施: tooth removal and cystostomy (Procedure)

Odontogenic cyst treated by decompression with an appliance.

Experimental

Cystostomy procedure is carried out with the same day delivery of a decompression appliance fabricated with a fully digital workflow. Enucleation of the cyst is carried out following decompression.

干预措施: Decompression (Procedure)

Odontogenic cyst treated by decompression with an appliance.

Experimental

Cystostomy procedure is carried out with the same day delivery of a decompression appliance fabricated with a fully digital workflow. Enucleation of the cyst is carried out following decompression.

干预措施: Postoperative Cone Beam Computed Tomography (CBCT) scan (Diagnostic Test)

Odontogenic cyst treated by decompression with an appliance.

Experimental

Cystostomy procedure is carried out with the same day delivery of a decompression appliance fabricated with a fully digital workflow. Enucleation of the cyst is carried out following decompression.

干预措施: Cyst Enucleation (Procedure)

结局指标

主要结局

Recurrence

时间窗: One year after enucleation

During follow up recurrence of the odontogenic cyst is observed

Success of the treatment of the odontogenic cyst by the approach described

时间窗: Decompression may take at least 6 months up to 18 months and lasts until the enucleation may be carried out with minimal risk of complicatios to anatomical landmarks included in the cyst.

The odontogenic cyst is resolved clinically and radiologically by bony healing

次要结局

  • Volumetric changes(6 months to 18 months. The timeframe of decompression.)

研究者

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

Marton Kivovics

Head of the Oral Surgery Unit

Semmelweis University

研究点 (2)

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