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

Primary Purpose

Odontogenic Cysts

Status
Recruiting
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Preoperative Cone Beam Computed Tomography (CBCT) scan
tooth removal and cystostomy
Decompression
Postoperative Cone Beam Computed Tomography (CBCT) scan
Cyst Enucleation
Sponsored by
Semmelweis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Odontogenic Cysts focused on measuring 3D printing, rapid prototyping, decompression, enucleation, cystostomy

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Semmelweis University Department of Community DentistryRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Odontogenic cyst treated by decompression with an appliance.

Arm Description

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.

Outcomes

Primary Outcome Measures

Success of the treatment of the odontogenic cyst by the approach described
The odontogenic cyst is resolved clinically and radiologically by bony healing
Recurrence
During follow up recurrence of the odontogenic cyst is observed

Secondary Outcome Measures

Volumetric changes
Volumetric changes of the cyst cavity during decompression.

Full Information

First Posted
February 15, 2022
Last Updated
May 31, 2023
Sponsor
Semmelweis University
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1. Study Identification

Unique Protocol Identification Number
NCT05253261
Brief Title
Decompression of Odontogenic Cysts Using an Appliance Fabricated With a Fully Digital Workflow
Official Title
Decompression of Odontogenic Cysts Using an Appliance Fabricated With a Fully Digital Workflow
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Semmelweis University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Odontogenic Cysts
Keywords
3D printing, rapid prototyping, decompression, enucleation, cystostomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Odontogenic cyst treated by decompression with an appliance.
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Preoperative Cone Beam Computed Tomography (CBCT) scan
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
tooth removal and cystostomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Decompression
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Postoperative Cone Beam Computed Tomography (CBCT) scan
Intervention Description
Postoperative CBCT examination is performed six months into the decompression period using the same scanning conditions as those used for the preoperative CBCT scan.
Intervention Type
Procedure
Intervention Name(s)
Cyst Enucleation
Intervention Description
Following the decompression period enucleation of the remaining cyst is carried out in local anaesthesia.
Primary Outcome Measure Information:
Title
Success of the treatment of the odontogenic cyst by the approach described
Description
The odontogenic cyst is resolved clinically and radiologically by bony healing
Time Frame
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.
Title
Recurrence
Description
During follow up recurrence of the odontogenic cyst is observed
Time Frame
One year after enucleation
Secondary Outcome Measure Information:
Title
Volumetric changes
Description
Volumetric changes of the cyst cavity during decompression.
Time Frame
6 months to 18 months. The timeframe of decompression.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Márton Kivovics, DMD MSc PhD
Phone
0036303780476
Email
kivovics.marton@dent.semmelweis-univ.hu
First Name & Middle Initial & Last Name or Official Title & Degree
Dorottya Pénzes, DMD MSc
Email
penzes.dorottya@dent.semmelweis-univ.hu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Márton Kivovics, DMD MSc PhD
Organizational Affiliation
Semmelweis University Department of Community Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Semmelweis University Department of Community Dentistry
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Márton Kivovics, DMD MSc PhD
Phone
0036303780476
Email
kivovics.marton@dent.semmelweis-univ.hu
First Name & Middle Initial & Last Name & Degree
Dorottya Pénzes, DMD MSc
Email
penzes.dorottya@dent.semmelweis-univ.hu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36116543
Citation
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.
Results Reference
derived

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

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