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Clinical Trials/NCT06133764
NCT06133764CompletedNot Applicable

Analysis of Odontogenic Keratocyst Treated With Various Modalities Over a 10-year

Qassim University1 site in 1 country50 target enrollmentStarted: February 24, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
Measurement of the bony cavity

Study Overview

Brief 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

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Masking Description

The patients, investigators, and outcomes assessor will not be informed about the study

Eligibility Criteria

Ages
10 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •All odontogenic keratocysts that are treated by the following surgical treatment modalities:
  • •Enucleation followed by peripheral ostectomy and Carnoy's solution
  • •Decompression/ marsupialization
  • •Enucleation
  • •Enucleation and Carnoy's solution
  • •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

Arms & Interventions

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

Experimental

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

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

Decompression/marsupialization (D/M)

Experimental

The odontogenic keratocysts will be managed by either Decompression or marsupialization

Intervention: Decompression/ marsupialization (D/M) (Procedure)

Enucleation (E)

Experimental

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

Intervention: Enucleation (E) (Procedure)

Enucleation+Carnoy's solution (E+CS)

Experimental

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

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

Enucleation+ Peripheral Ostectomy (E+PO)

Experimental

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

Intervention: Enucleation+ Peripheral Ostectomy (E+ PO) (Procedure)

Outcomes

Primary Outcomes

Measurement of the bony cavity

Time Frame: At the end of the postoperative ninth month

A presence of radiolucent area in the computed tomography scans

Recurrence rate

Time Frame: At the end of the postoperative tenth year

The new occurrence of the previously removed odontogenic keratocyst will be documented

Healing period

Time Frame: Starting from the postoperative third month up to the postoperative ninth month

The bone filling will monitored by using computed tomography scans

Recurrence rate

Time Frame: At the end of the postoperative fifth year

The new occurrence of the previously removed odontogenic keratocyst will be documented

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ghada Amin Khalifa, PhD

Professor of Maxillofacial Surgery and Diagnostic Science

Qassim University

Study Sites (1)

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