Odontogenic CystsNCT06688851
Patient Specific Implants (PSIs) for the Decompression of Odontogenic Cysts
An observational study of Odontogenic Cysts and Odontogenic Keratocyst, run by Semmelweis University at 1 site in Hungary.
Trial summary
This study aims to assess the feasibility of the decompression of odontogenic cysts using Patient Specific Implants anchored subperiosteally using osteosynthesis screws. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Odontogenic Cysts, Odontogenic Keratocyst
- What is being tested?
- Preoperative Cone Beam Computed Tomography (CBCT) scan, Cystostomy and Histology to confirm the initial diagnosis
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteHungary
- Study dates
- 26 Nov 2024to Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of the Department of Public Dental Health, Semmelweis University, presenting with odontogenic cysts of the jaws.
Who may be able to join
- -Patients of the Department of Public Dental Health, Semmelweis University, presenting with odontogenic cysts of the jaws that involve anatomical landmarks are included in the study.
Who cannot join
- Patients who have uncontrolled major systemic diseases as classified by the American Society of Anesthesiologists (ASA grades III-IV)
- Cancer of the oral cavity
- History of irradiation therapy in the head and neck region within the previous five years,
- History of uncontrolled psychiatric disorders,
- Unwillingness to return for follow-up appointments.
- Patients on medications interfering with bone metabolism, including steroid therapy and antiresorptive medication
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Márton Kivovics, Doctor of Dental Medicine contact
Hungary1 site, 1 recruiting
- Recruiting
Department of Public Dental Health
Budapest, Budapest, 1088
Márton Kivovics, Doctor of Dental Medicine, 003614591500 ext. 60732, kivovics.marton@semmelweis.hu
Márk Répási, Doctor of Dental Medicine, 003614591500 ext. 60759, repasi.mark@semmelweis.hu
About this study
Official title: Patient Specific Implants for the Decompression of Odontogenic Cysts
This study aims to assess the feasibility of the decompression of odontogenic cysts using Patient Specific Implants anchored subperiosteally using osteosynthesis screws.
Read the detailed description
Preoperative Imaging and PSIs The digital impression of the dentition or the edentulous jaw is captured using an intraoral scanner and a CBCT scan is performed for each patient enrolled in the study.
Standard Tessellation Language (STL) and Digital Imaging and Communications in Medicine (DICOM) files are imported and registered in the software used for designing the Patient Specific Implants (PSI). The PSI consists of a plate that enables the fixation of the appliance subperiosteally on the bone using osteosynthesis screws and a tube allowing the continuous discharge of the cystic liquid into the oral cavity. The decreased pressure within the cyst enables bone regeneration during the decompression period.
The PSI is produced using Selective Laser Melting (SLM) technology with Titanium. Before the surgical procedure, the PSI undergoes disinfection and sterilization.
Surgical Interventions Under local anesthesia, a full-thickness flap is prepared and cystostomy is performed. A sample of the cyst lining is sent for histological diagnosis. The PSI is fixed on the surface of the bone using osteosynthesis screws. The flap is sutured around the tube of the PSI. After one week the sutures are removed.
Patients are recalled monthly for controls and panoramic X-rays are performed to monitor the decompression.
A post-operative CBCT scan is conducted six months after cystostomy to assess whether the cyst volume has sufficiently decreased for enucleation to be performed with minimal risk of damaging anatomical landmarks.
Under local anesthesia, a full-thickness flap is raised and the PSI is removed by unscrewing the osteosynthesis screws. The wall of the cyst is completely enucleated and the flap is sutured. The residual cyst lining is sent for histopathologic examination.
Data acquisition The complications are documented in the patient's chart after surgical interventions and during follow-up appointments. The volume of the cyst is measured on the CBCT reconstructions before and after decompression to evaluate the effectiveness of the approach described.
- Conditions
- Odontogenic Cysts, Odontogenic Keratocyst
- Being tested
- Preoperative Cone Beam Computed Tomography (CBCT) scan, Cystostomy, Histology to confirm the initial diagnosis, Patient Specific Implant, Cyst decompression
- Keywords
- cyst decompression, enucleation, customized implant, Patient Specific Implat (PSI)
- 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
A CBCT scan is performed before the surgical intervention.
CystostomyProcedure or surgery
Under local anesthesia, a full-thickness flap is prepared and cystostomy is performed.
Histology to confirm the initial diagnosisDiagnostic test
A sample of the cyst lining is sent for histologic diagnosis.
Patient Specific ImplantDevice
The PSI is fixed on the surface of the bone using osteosynthesis screws.
Cyst decompressionProcedure or surgery
The PSI enables the discharge of the cystic liquid into the oral cavity. The resulting decrease in cystic pressure induces bone healing. Patients are recalled monthly for controls and panoramic X-rays are performed to monitor the decompression.
CBCTDiagnostic test
Post-operative CBCT is performed six months after cystostomy to assess whether the cyst volume has been sufficiently reduced for enucleation, minimizing the risk of damage to anatomical landmarks.
EnucleationProcedure or surgery
Under local anesthesia a full-thickness flap is raised and the PSI is removed by unscrewing the osteosynthesis screws. The wall of the cyst is completely enucleated and the flap is sutured.
Histology performed on the entire lining of the cystDiagnostic test
The residual cyst wall is sent for histopathologic examination.
| Study group | Role | What they receive |
|---|---|---|
| Management of the odontogenic cyst using a Patient Specific Implant (PSI) | Patients diagnosed with odontogenic cysts are included in this study. Cone Beam Computed Tomography (CBCT) and Intraoral Scans are performed and registered in a software for the design of Patient Specific Implants (PSI). A customized implant is designed and manufactured using Selective Laser Melting (SLM). Under local anesthesia, cystostomy is performed, and the wall of the cyst is sampled for histological diagnosis. The PSI is anchored subperiosteally on the bone using osteosynthesis screws. After a 6-month-long decompression period a CBCT scan is performed to determine whether enucleation of the cyst is feasible. Enucleation of the cyst is performed and the remaining cyst lining is sent for histopathological examination. Receives: Diagnostic Test: Preoperative Cone Beam Computed Tomography (CBCT) scan; Procedure: Cystostomy; Diagnostic Test: Histology to confirm the initial diagnosis; Device: Patient Specific Implant; Procedure: Cyst decompression; Diagnostic Test: CBCT; Procedure: Enucleation; Diagnostic Test: Histology performed on the entire lining of the cyst |
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
Intra- and postoperative complications associated with surgery
Number of cases where bleeding, damage to neighboring teeth, roots, and anatomical structures, nerve damage, antro-oral communication or fistula, antro-nasal communication or fistula, inflammation is observed during follow up.
Measured: through study completion, an average of 1 years
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 posted14 Nov 2024
- Study start26 Nov 2024
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marton Kivovics, Semmelweis University
- Investigators
- Márton Kivovics, Doctor of Dental Medicine, Principal investigator, Department of Public Dental Health, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688851
- Sponsor's protocol ID
- SEDCD55
- Status last verified
- Apr 2026
- First submitted
- 12 Nov 2024
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual Participant Data (IPD) that underlie the results after de-identification.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Specific Implants for the Decompression of Odontogenic Cysts
- ClinicalTrials.gov ID
- NCT06688851
- Acronym / sponsor ID
- SEDCD55
- Conditions
- Odontogenic Cysts, Odontogenic Keratocyst
- Keywords
- cyst decompression, enucleation, customized implant, Patient Specific Implat (PSI)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 26 Nov 2024 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 14 Nov 2024 (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.
This study aims to assess the feasibility of the decompression of odontogenic cysts using Patient Specific Implants anchored subperiosteally using osteosynthesis screws.
Detailed description
Preoperative Imaging and PSIs The digital impression of the dentition or the edentulous jaw is captured using an intraoral scanner and a CBCT scan is performed for each patient enrolled in the study.
Standard Tessellation Language (STL) and Digital Imaging and Communications in Medicine (DICOM) files are imported and registered in the software used for designing the Patient Specific Implants (PSI). The PSI consists of a plate that enables the fixation of the appliance subperiosteally on the bone using osteosynthesis screws and a tube allowing the continuous discharge of the cystic liquid into the oral cavity. The decreased pressure within the cyst enables bone regeneration during the decompression period.
The PSI is produced using Selective Laser Melting (SLM) technology with Titanium. Before the surgical procedure, the PSI undergoes disinfection and sterilization.
Surgical Interventions Under local anesthesia, a full-thickness flap is prepared and cystostomy is performed. A sample of the cyst lining is sent for histological diagnosis. The PSI is fixed on the surface of the bone using osteosynthesis screws. The flap is sutured around the tube of the PSI. After one week the sutures are removed.
Patients are recalled monthly for controls and panoramic X-rays are performed to monitor the decompression.
A post-operative CBCT scan is conducted six months after cystostomy to assess whether the cyst volume has sufficiently decreased for enucleation to be performed with minimal risk of damaging anatomical landmarks.
Under local anesthesia, a full-thickness flap is raised and the PSI is removed by unscrewing the osteosynthesis screws. The wall of the cyst is completely enucleated and the flap is sutured. The residual cyst lining is sent for histopathologic examination.
Data acquisition The complications are documented in the patient's chart after surgical interventions and during follow-up appointments. The volume of the cyst is measured on the CBCT reconstructions before and after decompression to evaluate the effectiveness of the approach described.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Management of the odontogenic cyst using a Patient Specific Implant (PSI) | – | Diagnostic Test: Preoperative Cone Beam Computed Tomography (CBCT) scan, Procedure: Cystostomy, Diagnostic Test: Histology to confirm the initial diagnosis, Device: Patient Specific Implant, Procedure: Cyst decompression, Diagnostic Test: CBCT, Procedure: Enucleation, Diagnostic Test: Histology performed on the entire lining of the cystPatients diagnosed with odontogenic cysts are included in this study. Cone Beam Computed Tomography (CBCT) and Intraoral Scans are performed and registered in a software for the design of Patient Specific Implants (PSI). A customized implant is designed and manufactured using Selective Laser Melting (SLM). Under local anesthesia, cystostomy is performed, and the wall of the cyst is sampled for histological diagnosis. The PSI is anchored subperiosteally on the bone using osteosynthesis screws. After a 6-month-long decompression period a CBCT scan is performed to determine whether enucleation of the cyst is feasible. Enucleation of the cyst is performed and the remaining cyst lining is sent for histopathological examination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of the Department of Public Dental Health, Semmelweis University, presenting with odontogenic cysts of the jaws.
Key inclusion criteria (1 listed)
- -Patients of the Department of Public Dental Health, Semmelweis University, presenting with odontogenic cysts of the jaws that involve anatomical landmarks are included in the study.
Key exclusion criteria (6 listed)
- Patients who have uncontrolled major systemic diseases as classified by the American Society of Anesthesiologists (ASA grades III-IV)
- Cancer of the oral cavity
- History of irradiation therapy in the head and neck region within the previous five years,
- History of uncontrolled 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) scanA CBCT scan is performed before the surgical intervention. | Diagnostic test | Management of the odontogenic cyst using a Patient Specific Implant (PSI) |
| CystostomyUnder local anesthesia, a full-thickness flap is prepared and cystostomy is performed. | Procedure or surgery | Management of the odontogenic cyst using a Patient Specific Implant (PSI) |
| Histology to confirm the initial diagnosisA sample of the cyst lining is sent for histologic diagnosis. | Diagnostic test | Management of the odontogenic cyst using a Patient Specific Implant (PSI) |
| Patient Specific ImplantThe PSI is fixed on the surface of the bone using osteosynthesis screws. | Device | Management of the odontogenic cyst using a Patient Specific Implant (PSI) |
| Cyst decompressionThe PSI enables the discharge of the cystic liquid into the oral cavity. The resulting decrease in cystic pressure induces bone healing. Patients are recalled monthly for controls and panoramic X-rays are performed to monitor the decompression. | Procedure or surgery | Management of the odontogenic cyst using a Patient Specific Implant (PSI) |
| CBCTPost-operative CBCT is performed six months after cystostomy to assess whether the cyst volume has been sufficiently reduced for enucleation, minimizing the risk of damage to anatomical landmarks. | Diagnostic test | Management of the odontogenic cyst using a Patient Specific Implant (PSI) |
| EnucleationUnder local anesthesia a full-thickness flap is raised and the PSI is removed by unscrewing the osteosynthesis screws. The wall of the cyst is completely enucleated and the flap is sutured. | Procedure or surgery | Management of the odontogenic cyst using a Patient Specific Implant (PSI) |
| Histology performed on the entire lining of the cystThe residual cyst wall is sent for histopathologic examination. | Diagnostic test | Management of the odontogenic cyst using a Patient Specific Implant (PSI) |
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
Intra- and postoperative complications associated with surgery
Time frame: through study completion, an average of 1 years
Number of cases where bleeding, damage to neighboring teeth, roots, and anatomical structures, nerve damage, antro-oral communication or fistula, antro-nasal communication or fistula, inflammation is observed during follow up.
1 secondary outcome
Volumetric changes
Time frame: 6 months to 18 months. The timeframe of decompression.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: Yes. Individual Participant Data (IPD) that underlie the results after de-identification.
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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.
Márton Kivovics, Doctor of Dental Medicine contact
Márton Kivovics, Doctor of Dental Medicine principal investigator
Department of Public Dental Health, Semmelweis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Odontogenic Cysts and Odontogenic Keratocyst, 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 6 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: looking for participants now, as of the sponsor's last update on 24 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Márton Kivovics, Doctor of Dental Medicine (003614591500 ext. 60732, kivovics.marton@semmelweis.hu), or a site near the patient. 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 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2026.