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Risk-Based Selection of Treatment Modalities for Odontogenic Keratocysts: A 10-Year Randomized Clinical Trial

NCT ID: NCT06133764

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-24

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Odontogenic Cysts

Keywords

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Odontogenic cysts Odontogenic Keratocysts

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The patents will be divided into five groups according to the treatment modalities used to treat their odontogenic cysts
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
The patients, investigators, and outcomes assessor will not be informed about the study

Study Groups

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

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

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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.

Decompression/marsupialization (D/M)

The odontogenic keratocysts will be managed by either Decompression or marsupialization

Group Type EXPERIMENTAL

Decompression/ marsupialization (D/M)

Intervention Type PROCEDURE

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

Enucleation (E)

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

Group Type EXPERIMENTAL

Enucleation (E)

Intervention Type PROCEDURE

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).

Enucleation+Carnoy's solution (E+CS)

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

Group Type EXPERIMENTAL

Enucleation+Carnoy's solution (E+CS)

Intervention Type PROCEDURE

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).

Enucleation+ Peripheral Ostectomy (E+PO)

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

Group Type EXPERIMENTAL

Enucleation+ Peripheral Ostectomy (E+ PO)

Intervention Type PROCEDURE

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).

Interventions

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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.

Intervention Type 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

Intervention Type 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).

Intervention Type 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).

Intervention Type 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).

Intervention Type PROCEDURE

Other Intervention Names

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(E + PO+ CS) D/M E (E+CS) (E+PO)

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role collaborator

Qassim University

OTHER

Sponsor Role lead

Responsible Party

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Ghada Amin Khalifa, PhD

Professor of Maxillofacial Surgery and Diagnostic Science

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ghada A Khalifa, Professor

Role: PRINCIPAL_INVESTIGATOR

College of Dentistry, Qassim University, Saudi Arabia

Locations

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College of Dentistry, Qassim University

Buraidah, Al-Qassim Region, Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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23-40-03

Identifier Type: -

Identifier Source: org_study_id