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Completed

NCT Number: NCT06133764

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

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

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Key information

Conditions

Odontogenic Cysts Bone Cysts Cysts Jaw Cysts Jaw Diseases Musculoskeletal Diseases Neoplasms Stomatognathic Diseases

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

College of Dentistry, Qassim University

Buraidah, Al-Qassim Region, 1162, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: (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

Other names: 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).

Other names: 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).

Other names: (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).

Other names: (E+PO)

Primary outcomes

  1. 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

  2. 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

  3. Recurrence rate

    Time frame: At the end of the postoperative fifth year

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

  4. Recurrence rate

    Time frame: At the end of the postoperative tenth year

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

Sponsors and collaborators

Lead sponsor

Qassim University

Other

Collaborators

  • Al-Azhar University

Registry information

Official study title

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

Acronym: OKCs

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 15, 2023
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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