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

Recruiting

• Conditions: Odontogenic Cysts; Odontogenic Keratocyst

• Registration Number: NCT06688851
• Lead Sponsor: Semmelweis University

Brief 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.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-12
• Study First Submitted QC: 2024-11-12
• Study First Posted: 2024-11-14
• Study Start: 2024-11-26
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-28
• Primary Completion: 2028-01
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Success of the treatment of the odontogenic cyst by the approach described	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	One year after enucleation	During follow up recurrence of the odontogenic cyst is observed
Intra- and postoperative complications associated with surgery	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.

Secondary Outcome Measures

Name	Time	Method
Volumetric changes	6 months to 18 months. The timeframe of decompression.	Volumetric changes of the cyst cavity during decompression.

Trial Locations

Locations (1)

Department of Public Dental Health; 🇭🇺 Budapest, Hungary