Odontogenic CystsOKCsNCT06133764
Risk-Adapted Treatment Strategies for Odontogenic Keratocysts: A Long-Term Randomized Clinical Trial Quantifying Recurrence Reduction
A study testing Enucleation+ Peripheral Ostectomy+Carnoy's solution chemical cauterization (E+CS + PO), Decompression/ marsupialization (D/M) and Enucleation (E) in people with Odontogenic Cysts, run by Qassim University at 1 site in Saudi Arabia.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Odontogenic Cysts
- What is being tested?
- Enucleation+ Peripheral Ostectomy+Carnoy's solution chemical cauterization (E+CS + PO), Decompression/ marsupialization (D/M) and Enucleation (E)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 24 Feb 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cases treated with resection
- Cases showed neoplastic transformation in their pathology
- Cyst Like lesions
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
College of Dentistry, Qassim University
Buraidah, Al-Qassim Region, 1162
About this study
Official title: 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
Read the 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.
- Conditions
- Odontogenic Cysts
- Being tested
- Enucleation+ Peripheral Ostectomy+Carnoy's solution chemical cauterization (E+CS + PO), Decompression/ marsupialization (D/M), Enucleation (E), Enucleation+Carnoy's solution (E+CS), Enucleation+ Peripheral Ostectomy (E+ PO)
- Keywords
- Odontogenic cysts, Odontogenic Keratocysts
- Medical subject headings
- Odontogenic Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enucleation+ Peripheral Ostectomy+Carnoy's solution chemical cauterization (E+CS + PO)Procedure or surgery
Also called (E + PO+ CS)
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)Procedure or surgery
Also called 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
Enucleation (E)Procedure or surgery
Also called 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).
Enucleation+Carnoy's solution (E+CS)Procedure or surgery
Also called (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).
Enucleation+ Peripheral Ostectomy (E+ PO)Procedure or surgery
Also called (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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Decompression/ marsupialization (D/M) |
| Enucleation (E) | Experimental | The odontogenic keratocysts will only be managed by Enucleation (E) Receives: Procedure: Enucleation (E) |
| Enucleation+Carnoy's solution (E+CS) | Experimental | odontogenic keratocysts will be managed by Enucleation, followed by Carnoy's solution Receives: 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) Receives: Procedure: Enucleation+ Peripheral Ostectomy (E+ PO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing period
The bone filling will monitored by using computed tomography scans
Measured: 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
Measured: At the end of the postoperative ninth month
Recurrence rate
The new occurrence of the previously removed odontogenic keratocyst will be documented
Measured: At the end of the postoperative fifth year
Recurrence rate
The new occurrence of the previously removed odontogenic keratocyst will be documented
Measured: At the end of the postoperative tenth year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start24 Feb 2023
- Primary completion30 Jun 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Odontogenic CystsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patents will be divided into five groups according to the treatment modalities used to treat their odontogenic cysts
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qassim University
- Sponsor type
- University, hospital or other
- Collaborators
- Al-Azhar University
- Responsible party
- Principal investigator, Ghada Amin Khalifa, PhD, Qassim University
- Investigators
- Ghada A Khalifa, Professor, Principal investigator, College of Dentistry, Qassim University, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133764
- Sponsor's protocol ID
- 23-40-03
- Acronym
- OKCs
- Status last verified
- Dec 2025
- First submitted
- 8 Nov 2023
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be available on request by contact the principle investigator
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Odontogenic Keratocyst Treated With Various Modalities Over a 10-year
- ClinicalTrials.gov ID
- NCT06133764
- Acronym / sponsor ID
- OKCs / 23-40-03
- Conditions
- Odontogenic Cysts
- Keywords
- Odontogenic cysts, Odontogenic Keratocysts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Qassim UniversityUniversity, hospital or other
- Collaborators
- Al-Azhar University
- Study start
- 24 Feb 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 15 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- The patents will be divided into five groups according to the treatment modalities used to treat their odontogenic cysts
| Arm | Type | Receives |
|---|---|---|
| Enucleation + Peripheral ostectomy + Carnoy's solution chemical cauterization (E+ PO+ CS) | Experimental | Procedure: Enucleation+ Peripheral Ostectomy+Carnoy's solution chemical cauterization (E+CS + PO)The odontogenic keratocysts will be treated using enucleation, followed by peripheral ostectomy and then Carnoy's solution |
| Decompression/marsupialization (D/M) | Experimental | Procedure: Decompression/ marsupialization (D/M)The odontogenic keratocysts will be managed by either Decompression or marsupialization |
| Enucleation (E) | Experimental | Procedure: Enucleation (E)The odontogenic keratocysts will only be managed by Enucleation (E) |
| Enucleation+Carnoy's solution (E+CS) | Experimental | Procedure: Enucleation+Carnoy's solution (E+CS)odontogenic keratocysts will be managed by Enucleation, followed by Carnoy's solution |
| Enucleation+ Peripheral Ostectomy (E+PO) | Experimental | Procedure: Enucleation+ Peripheral Ostectomy (E+ PO)The odontogenic keratocysts will be treated using Enucleation, followed by peripheral ostectomy (E+PO) |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- All odontogenic keratocysts that are treated by the following surgical treatment modalities:
- Follow-up period 10 years
Key exclusion criteria (3 listed)
- Cases treated with resection
- Cases showed neoplastic transformation in their pathology
- Cyst Like lesions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enucleation+ Peripheral Ostectomy+Carnoy's solution chemical cauterization (E+CS + PO)Also: (E + PO+ CS)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. | Procedure or surgery | Enucleation + Peripheral ostectomy + Carnoy's solution chemical cauterization (E+ PO+ CS) |
| Decompression/ marsupialization (D/M)Also: D/MA surgical window will be created in the cyst wall to drain the contents while retaining continuity between the cyst and the oral cavity | Procedure or surgery | Decompression/marsupialization (D/M) |
| Enucleation (E)Also: EThe 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). | Procedure or surgery | Enucleation (E) |
| Enucleation+Carnoy's solution (E+CS)Also: (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). | Procedure or surgery | Enucleation+Carnoy's solution (E+CS) |
| Enucleation+ Peripheral Ostectomy (E+ PO)Also: (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). | Procedure or surgery | Enucleation+ Peripheral Ostectomy (E+PO) |
Primary outcome
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
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 fifth year
The new occurrence of the previously removed odontogenic keratocyst will be documented
Recurrence rate
Time frame: At the end of the postoperative tenth year
The new occurrence of the previously removed odontogenic keratocyst will be documented
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: Yes. All data will be available on request by contact the principle investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ghada A Khalifa, Professor principal investigator
College of Dentistry, Qassim University, Saudi Arabia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enucleation+ Peripheral Ostectomy+Carnoy's solution chemical cauterization (E+CS + PO), Decompression/ marsupialization (D/M) and Enucleation (E) in people with Odontogenic Cysts, run by Qassim University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing period (time frame: Starting from the postoperative third month up to the postoperative ninth month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.