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

RecruitingOBSERVATIONAL
Enrollment

20

Participants

Timeline

Start Date

November 26, 2024

Primary Completion Date

January 31, 2028

Study Completion Date

January 31, 2028

Conditions
Odontogenic CystsOdontogenic 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.

Trial Locations (1)

1088

RECRUITING

Department of Public Dental Health, Budapest

All Listed Sponsors
lead

Semmelweis University

OTHER