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

NCT06133764 | Completed

• 1 other identifier: 23-40-03
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Odontogenic Cysts

Keywords

Odontogenic cysts; Odontogenic Keratocysts

Outcome Measures

Primary Outcomes (4)

• Healing period

  The bone filling will monitored by using computed tomography scans

  Starting from the postoperative third month up to the postoperative ninth month

• Measurement of the bony cavity

  A presence of radiolucent area in the computed tomography scans

  At the end of the postoperative ninth month

• Recurrence rate

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

  At the end of the postoperative fifth year

• Recurrence rate

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

  At the end of the postoperative tenth year

Study Arms (5)

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

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

Decompression/marsupialization (D/M)

EXPERIMENTAL

The odontogenic keratocysts will be managed by either Decompression or marsupialization

Procedure: Decompression/ marsupialization (D/M)

Enucleation (E)

EXPERIMENTAL

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

Procedure: Enucleation (E)

Enucleation+Carnoy's solution (E+CS)

EXPERIMENTAL

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

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

Enucleation+ Peripheral Ostectomy (E+PO)

EXPERIMENTAL

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

Procedure: Enucleation+ Peripheral Ostectomy (E+ PO)

Interventions

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

Also known as: (E + PO+ CS)

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

Decompression/ marsupialization (D/M) 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

Also known as: D/M

Decompression/marsupialization (D/M)

Enucleation (E) 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).

Also known as: E

Enucleation (E)

Enucleation+Carnoy's solution (E+CS) 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).

Also known as: (E+CS)

Enucleation+Carnoy's solution (E+CS)

Enucleation+ Peripheral Ostectomy (E+ PO) 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).

Also known as: (E+PO)

Enucleation+ Peripheral Ostectomy (E+PO)

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Qassim University: lead
• Al-Azhar University: collaborator

Study Sites (1)

College of Dentistry, Qassim University

Buraidah, Al-Qassim Region, 1162, Saudi Arabia

Location

MeSH Terms

Conditions

Odontogenic Cysts

Interventions

Decompression; Eudragit E PO

Condition Hierarchy (Ancestors)

Jaw Cysts; Bone Cysts; Cysts; Neoplasms; Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Pressure; Mechanical Phenomena; Physical Phenomena

Study Officials

• Ghada A Khalifa, Professor

  College of Dentistry, Qassim University, Saudi Arabia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patients, investigators, and outcomes assessor will not be informed about the study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Maxillofacial Surgery and Diagnostic Science

Model Details: The patents will be divided into five groups according to the treatment modalities used to treat their odontogenic cysts

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 15, 2023
• Study Start: February 24, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 12 months after publication
• Access Criteria: Contact the principle investigator via email: g.khalifa@qu.edu.sa

Locations

SA (1)