NCT06688851

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

Patient Specific Implants for the Decompression of Odontogenic Cysts

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Semmelweis University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Odontogenic Cysts
• Odontogenic Keratocyst

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-11-26
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2024-11-14
• Last updated: 2024-11-29

Locations

1 site across 1 country: Hungary