Using custom implants to decompress jaw cysts
Patient Specific Implants for the Decompression of Odontogenic Cysts
This study is testing whether custom-made implants can help reduce jaw cysts and promote healing in patients with these cysts.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Semmelweis University Academic / other |
| Locations | 1 site (Budapest, Budapest) |
| Trial ID | NCT06688851 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility of using Patient Specific Implants (PSIs) for the decompression of odontogenic cysts. Patients undergo preoperative imaging, including digital impressions and CBCT scans, to design and produce PSIs using advanced 3D printing technology. The implants are anchored to the bone and allow for the continuous drainage of cystic fluid, promoting bone regeneration. Monthly follow-ups and imaging are conducted to monitor the progress of cyst volume reduction.
Who should consider this trial
Good fit: Ideal candidates are patients with odontogenic cysts of the jaws that involve anatomical landmarks and are seeking treatment at the Department of Public Dental Health, Semmelweis University.
Not a fit: Patients with uncontrolled major systemic diseases, oral cancer, or those on medications affecting bone metabolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the treatment of odontogenic cysts, leading to improved outcomes and reduced need for more invasive surgeries.
How similar studies have performed: While the use of PSIs is a novel approach in this context, similar studies in other areas of dental surgery have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Budapest, Budapest
- Department of Public Dental Health — Budapest, Budapest, Hungary (Recruiting)
Study contacts
- Principal investigator: Márton Kivovics, Doctor of Dental Medicine — Department of Public Dental Health, Semmelweis University
- Study coordinator: Márton Kivovics, Doctor of Dental Medicine
- Email: kivovics.marton@semmelweis.hu
- Phone: 003614591500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.