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

Qassim University

Status: Completed

Conditions: Odontogenic Cysts

Treatments: Procedure: Enucleation+ Peripheral Ostectomy (E+ PO); Procedure: Enucleation+Carnoy's solution (E+CS); Procedure: Enucleation+ Peripheral Ostectomy+Carnoy's solution chemical cauterization (E+CS + PO); Procedure: Decompression/ marsupialization (D/M); Procedure: Enucleation (E)

Study type: Interventional

Funder types: Other

Identifiers

NCT06133764

23-40-03

Details and patient eligibility

About

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

Full description

Since the middle of the 20th century, the odontogenic keratocyst (OKC) has been one of the maxillofacial region's most contentious pathological phenomena. It was initially misdiagnosed as a primordial cyst. After that, because of its severe clinical behavior and tendency to recur, it was no longer considered to be a part of its classification, also known as a odontogenic tumor. Then, In 2017, the OKC are re-classified as a cystic lesion. But still there is debate about their management. So, this study will be enrolled with the following objectives: to describe how odontogenic keratocysts are managed, to Discover the most favorable approach to manage OKC with the need to stop it from happening again To categorize the odontogenic keratocyst management outcomes into to the subsequent groups: (1) total resolution, (2) partial resolution; (3) Recurrence.

Enrollment: 50 patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All odontogenic keratocysts that are treated by the following surgical treatment modalities:

  1. Enucleation followed by peripheral ostectomy and Carnoy's solution
  2. Decompression/ marsupialization
  3. Enucleation
  4. Enucleation and Carnoy's solution
  5. Enucleation and Peripheral Ostectomy

• Follow-up period 10 years

Exclusion criteria

• Cases treated with resection
• Cases showed neoplastic transformation in their pathology
• Cyst Like lesions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 5 patient groups

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

Experimental group

Description:

The odontogenic keratocysts will be treated using enucleation, followed by peripheral ostectomy and then Carnoy's solution

Treatment:

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

Decompression/marsupialization (D/M)

Experimental group

Description:

The odontogenic keratocysts will be managed by either Decompression or marsupialization

Treatment:

Procedure: Decompression/ marsupialization (D/M)

Enucleation (E)

Experimental group

Description:

The odontogenic keratocysts will only be managed by Enucleation (E)

Treatment:

Procedure: Enucleation (E)

Enucleation+Carnoy's solution (E+CS)

Experimental group

Description:

odontogenic keratocysts will be managed by Enucleation, followed by Carnoy's solution

Treatment:

Procedure: Enucleation+Carnoy's solution (E+CS)

Enucleation+ Peripheral Ostectomy (E+PO)

Experimental group

Description:

The odontogenic keratocysts will be treated using Enucleation, followed by peripheral ostectomy (E+PO)

Treatment:

Procedure: Enucleation+ Peripheral Ostectomy (E+ PO)