NCT05253261

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Semmelweis University · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. Patients are recalled for clinical examination and radiographic control (panoramic radiographs) a year after enucleation to determine whether recurrence of the odontogenic cyst occurs or not.

Conditions

• Odontogenic Cysts

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Preoperative Cone Beam Computed Tomography (CBCT) scan	CBCT scans (Green X, Vatech, Hwaseong, Korea) are carried out prior to cystostomies. The scanning conditions are constant at 200 µm isotropic voxel size with 360° rotation, 94 kV tube voltage, 7.2 mA tube current and 9 s exposure time with a 15 × 8 cm field of view field of view (FOV).
PROCEDURE	tooth removal and cystostomy	Surgical interventions are carried out in local anaesthesia. If it is deemed that a tooth or teeth included in the odontogenic cyst is of hopeless prognosis, it is removed at the time of cystostomy procedure. During cystostomy a bony window is created to accessthe cyst. The lining of the cyst is opened to accomodate the tube of the decompression appliance. A sample from the lining of the cyst is sent for histologic evaluation to confirm the diagnosis of odontogenic cyst.
PROCEDURE	Decompression	The decompression appliances is delivered in the same sitting as the cystostomy. Patients are instructed on how to wear and clean their decompression device and are recalled for clinical examinations.
DIAGNOSTIC_TEST	Postoperative Cone Beam Computed Tomography (CBCT) scan	Postoperative CBCT examination is performed six months into the decompression period using the same scanning conditions as those used for the preoperative CBCT scan.
PROCEDURE	Cyst Enucleation	Following the decompression period enucleation of the remaining cyst is carried out in local anaesthesia.

Timeline

• Start date: 2021-01-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2022-02-23
• Last updated: 2024-07-24

Locations

1 site across 1 country: Hungary