Patient Specific Implants (PSIs) for the Decompression of Odontogenic Cysts
Patient Specific Implants for the Decompression of Odontogenic Cysts
1 other identifier
observational
20
1 country
1
Brief Summary
This study aims to assess the feasibility of the decompression of odontogenic cysts using Patient Specific Implants anchored subperiosteally using osteosynthesis screws.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2024
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2024
CompletedFirst Posted
Study publicly available on registry
November 14, 2024
CompletedStudy Start
First participant enrolled
November 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
April 24, 2026
April 1, 2026
3.1 years
November 12, 2024
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Secondary Outcomes (1)
Volumetric changes
6 months to 18 months. The timeframe of decompression.
Study Arms (1)
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.
Interventions
A CBCT scan is performed before the surgical intervention.
Under local anesthesia, a full-thickness flap is prepared and cystostomy is performed.
A sample of the cyst lining is sent for histologic diagnosis.
The PSI is fixed on the surface of the bone using osteosynthesis screws.
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.
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.
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 wall is sent for histopathologic examination.
Eligibility Criteria
Patients of the Department of Public Dental Health, Semmelweis University, presenting with odontogenic cysts of the jaws.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Public Dental Health
Budapest, Budapest, 1088, Hungary
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Márton Kivovics, Doctor of Dental Medicine
Department of Public Dental Health, Semmelweis University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associate professor
Study Record Dates
First Submitted
November 12, 2024
First Posted
November 14, 2024
Study Start
November 26, 2024
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
January 1, 2028
Last Updated
April 24, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- 1 year following the end date
- Access Criteria
- Immediately following publication. No end date.
Individual Participant Data (IPD) that underlie the results after de-identification.