Clinical trial · Observational
Patient Specific Implants (PSIs) for the Decompression of Odontogenic Cysts
Patient Specific Implants for the Decompression of Odontogenic Cysts
NCT06688851CI-TRIAL-00109314recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to assess the feasibility of the decompression of odontogenic cysts using Patient Specific Implants anchored subperiosteally using osteosynthesis screws.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Odontogenic Cysts | — | UNRESOLVED | — |
| Odontogenic Keratocyst | — | UNRESOLVED | — |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CBCT | Diagnostic Test | — | UNRESOLVED |
| Cyst decompression | Procedure | — | UNRESOLVED |
| Cystostomy | Procedure | — | UNRESOLVED |
| Enucleation | Procedure | — | UNRESOLVED |
| Histology performed on the entire lining of the cyst | Diagnostic Test | — | UNRESOLVED |
| Histology to confirm the initial diagnosis | Diagnostic Test | — | UNRESOLVED |
| Patient Specific Implant | Device | — | UNRESOLVED |
| Preoperative Cone Beam Computed Tomography (CBCT) scan | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Management of the odontogenic cyst using a Patient Specific Implant (PSI)
- description
- 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.
- interventionNames
- Diagnostic Test: Preoperative Cone Beam Computed Tomography (CBCT) scan
- Procedure: Cystostomy
- Diagnostic Test: Histology to confirm the initial diagnosis
- Device: Patient Specific Implant
- Procedure: Cyst decompression
- Diagnostic Test: CBCT
- Procedure: Enucleation
- Diagnostic Test: Histology performed on the entire lining of the cyst
Primary outcomes (3)
- measure
- Success of the treatment of the odontogenic cyst by the approach described
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.