Risk-Adapted Treatment Strategies for Odontogenic Keratocysts: A Long-Term Randomized Clinical Trial Quantifying Recurrence Reduction

Summary

Background The odontogenic keratocysts (OKCs) have been one of the maxillofacial region's most contentious pathological phenomena. Decompression/marsupialization (D/M), enucleation (E), enucleation + chemical cauterization with Carnoy's solution (E+CS), enucleation + peripheral ostectomy (E + PO), as opposed to enucleation + chemical cauterization with Carnoy's solution + peripheral ostectomy (E + CS + PO), were used during surgery to ensure that no epithelial remnants were left behind.

Rationale Through the management of OKC a recurrence could occur, the effectiveness of Decompression/marsupialization (D/M), Enucleation (E), Enucleation+Carnoy's solution chemical cauterization (E+CS), Enucleation+peripheral ostectomy (E+PO), Enucleation+Carnoy's solution chemical cauterization + peripheral ostectomy (E+CS + PO), will be analyzed

Conditions

• Odontogenic Cysts

Interventions

PROCEDURE

Enucleation+ Peripheral Ostectomy+Carnoy's solution chemical cauterization (E+CS + PO)

The enucleation procedures, which were meticulously carried out in order to remove the odontogenic keratocyst in one piece without breaking its lining or leaving any epithelial remnants.The peripheral ostectomy treatment will be carried out with a large spherical bur and plenty of irrigation.After filling the bone cavity with more sterile gauze, the Carnoy's solution was slowly injected into it with a plastic syringe. The gauze was continuously injected with CS until it was fully saturated without leaking too much into the surrounding tissues. The CS was held in place for 3 minutes.

PROCEDURE

Decompression/ marsupialization (D/M)

A surgical window will be created in the cyst wall to drain the contents while retaining continuity between the cyst and the oral cavity

PROCEDURE

Enucleation (E)

The enucleation will be accomplished in the same manner that it will be performed in the group of Enucleation+ Peripheral Ostectomy+Carnoy's solution chemical cauterization (E+ PO+ CS).

PROCEDURE

Enucleation+Carnoy's solution (E+CS)

Both enucleation and Carnoy's solution will be carried out as planned in the group Enucleation+ Peripheral Ostectomy+Carnoy's solution chemical cauterization (E+ PO+ CS).

PROCEDURE

Enucleation+ Peripheral Ostectomy (E+ PO)

Both enucleation and peripheral ostectomy will be carried out as planned in the group Enucleation+ Peripheral Ostectomy+ Carnoy's solution chemical cauterization (E+ PO+ CS).

Sponsors & Collaborators

• Al-Azhar University

  collaborator OTHER

• Qassim University

  lead OTHER

Principal Investigators

• Ghada A Khalifa, Professor · College of Dentistry, Qassim University, Saudi Arabia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

10 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-02-24

Primary Completion

2024-06-30

Completion

2024-12-31

Countries

• Saudi Arabia

Study Locations