Health TrialsbyHealthPanel

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

ConditionsOdontogenic CystsOdontogenic Keratocyst
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSemmelweis University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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,

Trial population

Patients of the Department of Public Dental Health, Semmelweis University, presenting with odontogenic cysts of the jaws.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Preoperative Cone Beam Computed Tomography (CBCT) scan

    Diagnostic test

    A CBCT scan is performed before the surgical intervention.

  • Cystostomy

    Procedure/Surgery

    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/Surgery

    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/Surgery

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Management of the odontogenic cyst using a Patient Specific Implant (PSI)8 interventions

Trial outcomes

Primary outcomes

1

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

The odontogenic cyst is resolved clinically and radiologically by bony healing

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.
2

Recurrence

During follow up recurrence of the odontogenic cyst is observed

Time frame
One year after enucleation
3

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.

Time frame
through study completion, an average of 1 years

Secondary outcomes

1

Volumetric changes

Volumetric changes of the cyst cavity during decompression.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Semmelweis University

Lead sponsor

Source ClinicalTrials.gov
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