Neoplasms

Symptoms and General Pathology

All Conditions

Musculoskeletal Diseases

Mouth and Tooth Diseases

Cysts

Odontogenic Cysts

Jaw Cysts

Bone Cysts

Jaw Diseases

Stomatognathic Diseases

Pharmaceutical Solutions

All Drugs and Chemicals

Antineoplastic Agents

Fluorouracil

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Enucleation of OKC followed by local application of 5% 5-fluorouracil cream. Drug will be applied on the gauze left in the enucleation defect for 24 hours, after which the gauze will be removed.

Enucleation of OKC followed by local application Carnoy solution. Carnoy solution will be applied into the cystic cavity for 5 minutes and bone defect will be treated by Carnoy solution for 3 minutes immediately after the enucleation.

Enucleation is complete removal of the cyst from the bony defect of the jaw affected by the lesion. Osteotomy is performed to allow access to the cyst, cystic wall is detached from the bone and removed completely.

Enucleation

Lesions clinically abd radiographically consistent with OKC will be submitted for histological examination to confirm the diagnosis of OKC

incisional biopsy

5% 5-fluorouracil cream will be applied immediately after the enucleation to the cystic cavity for 24 hours

Application of 5-fluorouracil

Carnoy solution will be applied during the enucleation as described previously

Application of Carnoy solution

Miroslav Andric

The goal of this clinical trial is to compare surgical treatment outcomes of odontogenic keratocysts (OKC) treated with enucleation and local application of Carnoy's solution or 5% 5-fluorouracil. The main questions it aims to answer are:

1. What is the recurrence rate of OKC treated with enucleation and local application of 5% 5-fluorouracil cream in the period of three and five years after the treatment
2. What is the recurrence rate of OKC treated with enucleation and local application of Carnoy's solution in the period of three and five years after the treatment
3. Is there a difference in the recurrence rate between these two groups
4. What is the frequency of sensitivity disorders in the innervation zone of inferior alveolar and infraorbital nerves in both groups

Participants will be assigned to one of two groups after Histopathological verification (HP verification).They will be treated with enucleation and local application of Carnoy's solution or 5% 5-fluorouracil depending on group. After surgical treatment they will be monitored in accordance to standard treatment protocols for patients with OKC.

Usage of 5-fluorouracil and Carnoy's Solution in Surgical Treatment of Odontogenic Keratocysts

Usage of 5-fluorouracil and Carnoy's Solution in Surgical Treatment of Odontogenic Keratocysts - Randomized, Controlled Clinical Study

Number of participants with histologically verified OKC in site of previously treated OKC

dysesthesia and hypoesthesia in the surgical site

University of Belgrade

Professor of Oral Surgery and Implantology

Skin and Connective Tissue Diseases

Rare Diseases

Lichen Planus, Oral

Lichen Planus

Mouth Neoplasms

Precancerous Conditions

Leukoplakia

Leukoplakia, Oral

Lichenoid Eruptions

Exanthema

Skin Diseases

Skin Diseases, Papulosquamous

Head and Neck Neoplasms

Mouth Diseases

Pathological Conditions, Anatomical

Oral Cancer

Lip and Oral Cavity Cancer

Oral Leukoplakia

patients diagnosed clinically and histopathologically with oral cancer who have yet to receive any treatment.

patients diagnosed clinically and histopathologically with oral potentially malignant lesions who have not yet to receive treatment or had a month wash-out period from any previous treatment.

healthy individuals who will be examined clinically through conventional visual and tactile examination to ensure no oral lesions are present and through thorough medical history

Gamma-synuclein salivary levels measured using ELISA assay

Salivary Gamma-synuclein

A) Biopsy (reference standard): biopsy for group 1 will be performed by specialists in the national cancer institute.

B) Biopsy for oral potentially malignant lesions will be performed by the candidate from the most representative region.

Incisional biopsy

Conventional visual and tactile examination using light and mirror

Conventional visual and tactile examination

Fat'heya Zahran

Noha Azab

Synucleins are a family of small, highly conserved proteins found in vertebrates and are specially abundant in neurons particularly in presynaptic terminals (Surguchov et al., 2001). Gamma-synuclein is the third member of the synuclein family, and is predominantly found in the cytosol of tumor cells and functions both intra- and extra-cellularly. It is involved in the pathogenesis of different types of cancer and some neurodegenerative diseases (Liu et al., 2018). Smoking - a major risk factor for oral cancer and its progression - and nicotine-containing products were found to time-dependently up-regulate the Gamma-synuclein expression in cancer cells (Hsu et al., 2020a).

Gamma-synuclein is released from tumor cells and was found to be elevated in tumors such as urinary bladder cancer (Liu et al., 2016), colorectal cancer, gastric adenocarcinomas and esophageal cancer (Liu et al., 2012). It is present in blood, serum, cerebrospinal fluid and saliva. The detection of extracellular synucleins in body fluids can reveal the first steps of the disease thus it can be used as a potential tool for early cancer detection (Surguchov, 2016).

This study aims to identify the diagnostic accuracy of Gamma-synuclein in differentiating between oral malignant lesions and oral premalignant lesions.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Usage of 5-fluorouracil and Carnoy's Solution in Surgical Treatment of Odontogenic Keratocysts	NCT06096220	Odontogenic Ker...	Enucleation incisional biop... Application of ... Application of ...	18 Years - 70 Years	University of Belgrade
Diagnostic Accuracy of Salivary Gamma-synuclein in Oral Malignant and Premalignant Lesions	NCT04732741	Oral Cancer Oral Lichen Pla... Oral Leukoplaki... Premalignant Le...	Salivary Gamma-... Incisional biop... Conventional vi...	20 Years - 80 Years	Cairo University

Spots Global Cancer Trial Database for incisional biopsy