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

NCT06688851 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2026-04-24

No results posted yet for this study

Summary

This study aims to assess the feasibility of the decompression of odontogenic cysts using Patient Specific Implants anchored subperiosteally using osteosynthesis screws.

Conditions

  • Odontogenic Cysts
  • Odontogenic Keratocyst

Interventions

DIAGNOSTIC_TEST

Preoperative Cone Beam Computed Tomography (CBCT) scan

A CBCT scan is performed before the surgical intervention.

PROCEDURE

Cystostomy

Under local anesthesia, a full-thickness flap is prepared and cystostomy is performed.

DIAGNOSTIC_TEST

Histology to confirm the initial diagnosis

A sample of the cyst lining is sent for histologic diagnosis.

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

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.

Sponsors & Collaborators

  • Semmelweis University

    lead OTHER

Principal Investigators

  • Márton Kivovics, Doctor of Dental Medicine · Department of Public Dental Health, Semmelweis University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-26
Primary Completion
2028-01-31
Completion
2028-01-31

Countries

  • Hungary

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06688851 on ClinicalTrials.gov