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

NCT05253261 | Completed

• 1 other identifier: 2020/109DD
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Odontogenic Cysts

Keywords

3D printing; rapid prototyping; decompression; enucleation; cystostomy

Outcome Measures

Primary Outcomes (2)

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

  The odontogenic cyst is resolved clinically and radiologically by bony healing

  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.

• Recurrence

  During follow up recurrence of the odontogenic cyst is observed

  One year after enucleation

Secondary Outcomes (1)

• Volumetric changes

  6 months to 18 months. The timeframe of decompression.

Study Arms (1)

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.

Diagnostic Test: Preoperative Cone Beam Computed Tomography (CBCT) scan; Procedure: tooth removal and cystostomy; Procedure: Decompression; Diagnostic Test: Postoperative Cone Beam Computed Tomography (CBCT) scan; Procedure: Cyst Enucleation

Interventions

Preoperative Cone Beam Computed Tomography (CBCT) scan DIAGNOSTIC_TEST

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).

Odontogenic cyst treated by decompression with an appliance.

tooth removal and cystostomy PROCEDURE

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.

Odontogenic cyst treated by decompression with an appliance.

Decompression PROCEDURE

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.

Odontogenic cyst treated by decompression with an appliance.

Postoperative Cone Beam Computed Tomography (CBCT) scan DIAGNOSTIC_TEST

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

Odontogenic cyst treated by decompression with an appliance.

Cyst Enucleation PROCEDURE

Following the decompression period enucleation of the remaining cyst is carried out in local anaesthesia.

Odontogenic cyst treated by decompression with an appliance.

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Semmelweis University Department of Community Dentistry

Budapest, Budapest, 1088, Hungary

Location

Related Publications (1)

• Kivovics M, Penzes D, Moldvai J, Mijiritsky E, Nemeth O. A custom-made removable appliance for the decompression of odontogenic cysts fabricated using a digital workflow. J Dent. 2022 Nov;126:104295. doi: 10.1016/j.jdent.2022.104295. Epub 2022 Sep 15.

  PMID: 36116543 DERIVED

MeSH Terms

Conditions

Odontogenic Cysts

Interventions

Radionuclide Imaging; Tooth Extraction; Cystostomy; Decompression

Condition Hierarchy (Ancestors)

Jaw Cysts; Bone Cysts; Cysts; Neoplasms; Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Radioisotope; Oral Surgical Procedures; Surgical Procedures, Operative; Dentistry; Ostomy; Urinary Diversion; Urologic Surgical Procedures; Urogenital Surgical Procedures; Therapeutics; Pressure; Mechanical Phenomena; Physical Phenomena

Study Officials

• Márton Kivovics, DMD MSc PhD

  Semmelweis University Department of Community Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Oral Surgery Unit

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: February 23, 2022
• Study Start: January 1, 2021
• Primary Completion: March 31, 2026
• Study Completion: April 15, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)