Patient Specific Implants (PSIs) for the Decompression of Odontogenic Cysts
NCT ID: NCT06688851
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
20 participants
OBSERVATIONAL
2024-11-26
2028-01-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Preoperative Cone Beam Computed Tomography (CBCT) scan
A CBCT scan is performed before the surgical intervention.
Cystostomy
Under local anesthesia, a full-thickness flap is prepared and cystostomy is performed.
Histology to confirm the initial diagnosis
A sample of the cyst lining is sent for histologic diagnosis.
Patient Specific Implant
The PSI is fixed on the surface of the bone using osteosynthesis screws.
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.
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.
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.
Histology performed on the entire lining of the cyst
The residual cyst wall is sent for histopathologic examination.
Interventions
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Preoperative Cone Beam Computed Tomography (CBCT) scan
A CBCT scan is performed before the surgical intervention.
Cystostomy
Under local anesthesia, a full-thickness flap is prepared and cystostomy is performed.
Histology to confirm the initial diagnosis
A sample of the cyst lining is sent for histologic diagnosis.
Patient Specific Implant
The PSI is fixed on the surface of the bone using osteosynthesis screws.
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.
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.
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.
Histology performed on the entire lining of the cyst
The residual cyst wall is sent for histopathologic examination.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Semmelweis University
OTHER
Responsible Party
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Marton Kivovics
associate professor
Principal Investigators
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Márton Kivovics, Doctor of Dental Medicine
Role: PRINCIPAL_INVESTIGATOR
Department of Public Dental Health, Semmelweis University
Locations
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Department of Public Dental Health
Budapest, Budapest, Hungary
Countries
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Central Contacts
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Facility Contacts
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Márton Kivovics, Doctor of Dental Medicine
Role: backup
Other Identifiers
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SEDCD55
Identifier Type: -
Identifier Source: org_study_id