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NCT Number: NCT06688851

Patient Specific Implants (PSIs) for the Decompression of Odontogenic Cysts

This study aims to assess the feasibility of the decompression of odontogenic cysts using Patient Specific Implants anchored subperiosteally using osteosynthesis screws.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Public Dental Health

Budapest, 1088, Hungary

Location status: Recruiting

Location contact

Márk Répási, Doctor of Dental Medicine

CONTACT

[email protected]

003614591500 ext. 60759

Márton Kivovics, Doctor of Dental Medicine

CONTACT

[email protected]

003614591500 ext. 60732

Márton Kivovics, Doctor of Dental Medicine

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preoperative Cone Beam Computed Tomography (CBCT) scan

Diagnostic Test

A CBCT scan is performed before the surgical intervention.

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.

Primary outcomes

  1. Success of the treatment of the odontogenic cyst by the approach described

    Time frame: 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.

    The odontogenic cyst is resolved clinically and radiologically by bony healing

  2. Recurrence

    Time frame: One year after enucleation

    During follow up recurrence of the odontogenic cyst is observed

  3. Intra- and postoperative complications associated with surgery

    Time frame: through study completion, an average of 1 years

    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.

Secondary outcomes

  1. Volumetric changes

    Time frame: 6 months to 18 months. The timeframe of decompression.

    Volumetric changes of the cyst cavity during decompression.

Study contacts

Contact information is provided by the study sponsor or research team.

Márk Répási, Doctor of Dental Medicine

CONTACT

[email protected]

003614591500 ext. 60759

Márton Kivovics, Doctor of Dental Medicine

CONTACT

[email protected]

003614591500 ext. 60732

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Registry information

Official study title

Patient Specific Implants for the Decompression of Odontogenic Cysts

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Nov 14, 2024
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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