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This study aims to assess the feasibility of the decompression of odontogenic cysts using Patient Specific Implants anchored subperiosteally using osteosynthesis screws.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative Cone Beam Computed Tomography (CBCT) scan | Diagnostic Test | A CBCT scan is performed before the surgical intervention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Success of the treatment of the odontogenic cyst by the approach described | 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 | During follow up recurrence of the odontogenic cyst is observed | One year after enucleation |
| Intra- and postoperative complications associated with surgery | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Volumetric changes | Volumetric changes of the cyst cavity during decompression. | 6 months to 18 months. The timeframe of decompression. |
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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:
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Patients of the Department of Public Dental Health, Semmelweis University, presenting with odontogenic cysts of the jaws.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Márton Kivovics, Doctor of Dental Medicine | Contact | 003614591500 | 60732 | kivovics.marton@semmelweis.hu |
| Márk Répási, Doctor of Dental Medicine | Contact | 003614591500 | 60759 | repasi.mark@semmelweis.hu |
| Name | Affiliation | Role |
|---|---|---|
| Márton Kivovics, Doctor of Dental Medicine | Department of Public Dental Health, Semmelweis University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Public Dental Health | Recruiting | Budapest | Budapest | 1088 | Hungary |
Individual Participant Data (IPD) that underlie the results after de-identification.
1 year following the end date
Immediately following publication. No end date.
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| Cystostomy | Procedure | Under local anesthesia, a full-thickness flap is prepared and cystostomy is performed. |
|
| Histology to confirm the initial diagnosis | Diagnostic Test | A sample of the cyst lining is sent for histologic diagnosis. |
|
| Patient Specific Implant | Device | The PSI is fixed on the surface of the bone using osteosynthesis screws. |
|
| Cyst decompression | Procedure | 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. |
|
| CBCT | Diagnostic Test | 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. |
|
| Enucleation | Procedure | 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. |
|
| Histology performed on the entire lining of the cyst | Diagnostic Test | The residual cyst wall is sent for histopathologic examination. |
|
| ID | Term |
|---|---|
| D009807 | Odontogenic Cysts |
| ID | Term |
|---|---|
| D007570 | Jaw Cysts |
| D001845 | Bone Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D011877 | Radionuclide Imaging |
| D003559 | Cystostomy |
| D015353 | Eye Enucleation |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003947 | Diagnostic Techniques, Radioisotope |
| D010030 | Ostomy |
| D013514 | Surgical Procedures, Operative |
| D014547 | Urinary Diversion |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
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