Patient Specific Implants (PSIs) for the Decompression of Odontogenic Cysts

April 21, 2026 updated by: Marton Kivovics, Semmelweis University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Hungary
    • Budapest
      • Budapest, Budapest, Hungary, 1088
        • Recruiting
        • Department of Public Dental Health
        • Contact:
        • Contact:
        • Principal Investigator:
          • Márton Kivovics, Doctor of Dental Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients of the Department of Public Dental Health, Semmelweis University, presenting with odontogenic cysts of the jaws.

Description

Inclusion Criteria:

-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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Procedure: Cystostomy
Under local anesthesia, a full-thickness flap is prepared and cystostomy is performed.
Device: Patient Specific Implant
The PSI is fixed on the surface of the bone using osteosynthesis screws.
Procedure: Cyst decompression
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.
Diagnostic test: Preoperative Cone Beam Computed Tomography (CBCT) scan
A CBCT scan is performed before the surgical intervention.
Diagnostic test: Histology to confirm the initial diagnosis
A sample of the cyst lining is sent for histologic diagnosis.
Diagnostic test: CBCT
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.
Procedure: Enucleation
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.
Diagnostic test: Histology performed on the entire lining of the cyst
The residual cyst wall is sent for histopathologic examination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: One year after enucleation
During follow up recurrence of the odontogenic cyst is observed
One year after enucleation
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.
through study completion, an average of 1 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volumetric changes
Time Frame: 6 months to 18 months. The timeframe of decompression.
Volumetric changes of the cyst cavity during decompression.
6 months to 18 months. The timeframe of decompression.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semmelweis University

Investigators

  • Principal Investigator: Márton Kivovics, Doctor of Dental Medicine, Department of Public Dental Health, Semmelweis University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2024

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

November 12, 2024

First Submitted That Met QC Criteria

November 12, 2024

First Posted (Actual)

November 14, 2024

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEDCD55

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual Participant Data (IPD) that underlie the results after de-identification.

IPD Sharing Time Frame

1 year following the end date

IPD Sharing Access Criteria

Immediately following publication. No end date.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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