Odontogenic CystsNCT05253261
Decompression of Odontogenic Cysts Using an Appliance Fabricated With a Fully Digital Workflow
A study testing Preoperative Cone Beam Computed Tomography (CBCT) scan, tooth removal and cystostomy and Decompression in people with Odontogenic Cysts, run by Semmelweis University at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Odontogenic Cysts
- What is being tested?
- Preoperative Cone Beam Computed Tomography (CBCT) scan, tooth removal and cystostomy and Decompression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteHungary
- Study dates
- 1 Jan 2021to 15 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Semmelweis University Department of Community Dentistry
Budapest, Budapest, 1088
About this study
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.
Read the 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
- Being tested
- Preoperative Cone Beam Computed Tomography (CBCT) scan, tooth removal and cystostomy, Decompression, Postoperative Cone Beam Computed Tomography (CBCT) scan, Cyst Enucleation
- Keywords
- 3D printing, rapid prototyping, decompression, enucleation, cystostomy
- Medical subject headings
- Odontogenic Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Cone Beam Computed Tomography (CBCT) scanDiagnostic 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).
tooth removal and cystostomyProcedure or surgery
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.
DecompressionProcedure or surgery
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.
Postoperative Cone Beam Computed Tomography (CBCT) scanDiagnostic 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.
Cyst EnucleationProcedure or surgery
Following the decompression period enucleation of the remaining cyst is carried out in local anaesthesia.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of the treatment of the odontogenic cyst by the approach described
The odontogenic cyst is resolved clinically and radiologically by bony healing
Measured: 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
Measured: One year after enucleation
Secondary outcomes (1)
Volumetric changes
Volumetric changes of the cyst cavity during decompression.
Measured: 6 months to 18 months. The timeframe of decompression.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start1 Jan 2021
- Primary completion31 Mar 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Odontogenic CystsStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marton Kivovics, Semmelweis University
- Investigators
- Márton Kivovics, DMD MSc PhD, Principal investigator, Semmelweis University Department of Community Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253261
- Sponsor's protocol ID
- 2020/109DD
- Status last verified
- Apr 2026
- First submitted
- 15 Feb 2022
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36116543
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decompression of Odontogenic Cysts Using an Appliance Fabricated With a Fully Digital Workflow
- ClinicalTrials.gov ID
- NCT05253261
- Acronym / sponsor ID
- 2020/109DD
- Conditions
- Odontogenic Cysts
- Keywords
- 3D printing, rapid prototyping, decompression, enucleation, cystostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 23 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Odontogenic cyst treated by decompression with an appliance. | Experimental | 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 EnucleationCystostomy 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. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative Cone Beam Computed Tomography (CBCT) scanCBCT 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). | Diagnostic test | Odontogenic cyst treated by decompression with an appliance. |
| tooth removal and cystostomySurgical 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 or surgery | Odontogenic cyst treated by decompression with an appliance. |
| DecompressionThe 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. | Procedure or surgery | Odontogenic cyst treated by decompression with an appliance. |
| Postoperative Cone Beam Computed Tomography (CBCT) scanPostoperative CBCT examination is performed six months into the decompression period using the same scanning conditions as those used for the preoperative CBCT scan. | Diagnostic test | Odontogenic cyst treated by decompression with an appliance. |
| Cyst EnucleationFollowing the decompression period enucleation of the remaining cyst is carried out in local anaesthesia. | Procedure or surgery | Odontogenic cyst treated by decompression with an appliance. |
Primary outcome
Success of the treatment of the odontogenic cyst by the approach described
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.
The odontogenic cyst is resolved clinically and radiologically by bony healing
Recurrence
Time frame: One year after enucleation
During follow up recurrence of the odontogenic cyst is observed
1 secondary outcome
Volumetric changes
Time frame: 6 months to 18 months. The timeframe of decompression.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Derived from this study: PubMed 36116543Kivovics 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Márton Kivovics, DMD MSc PhD principal investigator
Semmelweis University Department of Community Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative Cone Beam Computed Tomography (CBCT) scan, tooth removal and cystostomy and Decompression in people with Odontogenic Cysts, run by Semmelweis University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of the treatment of the odontogenic cyst by the approach described (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05253261, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.