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

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

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

Study Overview

• Status: Completed
• Conditions: Odontogenic Cysts
• Intervention / Treatment: Procedure: Enucleation+ Peripheral Ostectomy+Carnoy's solution chemical cauterization (E+CS + PO); Procedure: Decompression/ marsupialization (D/M); Procedure: Enucleation (E); Procedure: Enucleation+Carnoy's solution (E+CS); Procedure: Enucleation+ Peripheral Ostectomy (E+ PO)

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Al-Qassim Region
    • Buraidah, Al-Qassim Region, Saudi Arabia, 1162
      • College of Dentistry, Qassim University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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.; Other Names: (E + PO+ CS)
Experimental: Decompression/marsupialization (D/M); The odontogenic keratocysts will be managed by either Decompression or marsupialization	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; Other Names: D/M
Experimental: Enucleation (E); The odontogenic keratocysts will only be managed by Enucleation (E)	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).; Other Names: E
Experimental: Enucleation+Carnoy's solution (E+CS); odontogenic keratocysts will be managed by Enucleation, followed by Carnoy's solution	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).; Other Names: (E+CS)
Experimental: Enucleation+ Peripheral Ostectomy (E+PO); The odontogenic keratocysts will be treated using Enucleation, followed by peripheral ostectomy (E+PO)	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).; Other Names: (E+PO)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Qassim University
• Collaborators: Al-Azhar University
• Investigators: Principal Investigator: Ghada A Khalifa, Professor, College of Dentistry, Qassim University, Saudi Arabia

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2023
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: November 13, 2023
• First Posted (Actual): November 15, 2023

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 4, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Odontogenic cysts; Odontogenic Keratocysts
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Neoplasms; Jaw Diseases; Cysts; Jaw Cysts; Bone Cysts; Odontogenic Cysts; Therapeutics; Mechanical Phenomena; Physical Phenomena; Pressure; Decompression; Eudragit E PO
• Other Study ID Numbers: 23-40-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data will be available on request by contact the principle investigator
• IPD Sharing Time Frame: 12 months after publication
• IPD Sharing Access Criteria: Contact the principle investigator via email: g.khalifa@qu.edu.sa
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No