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Trial Title:
Different Modalities of Management of Odontogenic Keratocysts
NCT ID:
NCT06133764
Condition:
Odontogenic Cysts
Conditions: Official terms:
Odontogenic Cysts
Ethanol
Acetic Acid
Pharmaceutical Solutions
Conditions: Keywords:
Odontogenic cysts
Odontogenic Keratocysts
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
The patents will be divided into five groups according to the treatment modalities used
to treat their odontogenic cysts
Primary purpose:
Treatment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking description:
The patients, investigators, and outcomes assessor will not be informed about the study
Intervention:
Intervention type:
Procedure
Intervention name:
Enucleation+ Peripheral Ostectomy+Carnoy's solution chemical cauterization (E+CS + PO)
Description:
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.
Arm group label:
Enucleation + Peripheral ostectomy + Carnoy's solution chemical cauterization (E+ PO+ CS)
Other name:
(E + PO+ CS)
Intervention type:
Procedure
Intervention name:
Decompression/ marsupialization (D/M)
Description:
A surgical window will be created in the cyst wall to drain the contents while retaining
continuity between the cyst and the oral cavity
Arm group label:
Decompression/marsupialization (D/M)
Other name:
D/M
Intervention type:
Procedure
Intervention name:
Enucleation (E)
Description:
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).
Arm group label:
Enucleation (E)
Other name:
E
Intervention type:
Procedure
Intervention name:
Enucleation+Carnoy's solution (E+CS)
Description:
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).
Arm group label:
Enucleation+Carnoy's solution (E+CS)
Other name:
(E+CS)
Intervention type:
Procedure
Intervention name:
Enucleation+ Peripheral Ostectomy (E+ PO)
Description:
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).
Arm group label:
Enucleation+ Peripheral Ostectomy (E+PO)
Other name:
(E+PO)
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
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
10 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
College of Dentistry, Qassim University
Address:
City:
Buraydah
Zip:
1162
Country:
Saudi Arabia
Status:
Recruiting
Contact:
Last name:
Ghada A Khalifa, Professor
Phone:
504840248
Phone ext:
+966
Email:
dean.office@qudent.org
Contact backup:
Last name:
Alaa K Alanzi, Student
Phone:
532417017
Phone ext:
+966
Email:
411216430@qu.edu.sa
Investigator:
Last name:
Alaa K Alanzi, Student
Email:
Principal Investigator
Start date:
February 24, 2023
Completion date:
January 31, 2025
Lead sponsor:
Agency:
Qassim University
Agency class:
Other
Collaborator:
Agency:
Al-Azhar University
Agency class:
Other
Source:
Qassim University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06133764
