NCT06833840

Brief Summary

The pathogenesis of odontogenic lesions remains unclear; however, a probable explanation may involve the existence of tumor stem cells (TSCs), which are thought to generate both benign and malignant tumors. The preservation of stem cells during early dental development is governed by many transcription factors, including sex-determining region Y (SRY)-box 2 (SOX-2). Numerous studies observed the increased expression of SOX2 in various benign and malignant tumors, as its impact on tumorigenesis varies according to tumor type. The purpose of this study is to assess the immunoexpression of the stem cell marker SOX2 in diverse types of odontogenic cysts and tumors in order to identify its prognostic significance and to show if it correlates to clinicopathologic parameters of those odontogenic lesions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 19, 2025

Completed
Last Updated

February 26, 2025

Status Verified

February 1, 2025

Enrollment Period

12 months

First QC Date

January 21, 2025

Last Update Submit

February 24, 2025

Conditions

Keywords

Ameloblastomaodontogenic keratocystdentigerous cystSOX2immunohistochemistry

Outcome Measures

Primary Outcomes (1)

  • SOX2 staining score

    Semi-quantitative method for subjectively scoring the immunohistochemical staining. Positive specimens were considered when the nucleus had brown staining.

    6 months

Study Arms (3)

Ameloblastoma group

patients diagnosed with ameloblastoma

Odontogenic keratocyst group

patients diagnosed with Odontogenic keratocyst

Dentigerous cyst group

patients diagnosed with Dentigerous cyst

Eligibility Criteria

Sexall(Gender-based eligibility)
Gender Eligibility Detailsmale and female
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients in the Outpatient Clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University.

You may qualify if:

  • \. Patients with benign odontogenic cysts and tumors which presented either in Maxilla or Mandible ( as indicated by incisional biopsies )

You may not qualify if:

  • Patients with systemic diseases that absolutely contraindicate surgical procedures.
  • Malignant odontogenic tumors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Mansoura University

Al Mansurah, Dakahlia Governorate, 12345, Egypt

Location

MeSH Terms

Conditions

Odontogenic CystsOdontogenic TumorsAmeloblastomaDentigerous Cyst

Condition Hierarchy (Ancestors)

Jaw CystsBone CystsCystsNeoplasmsJaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesNeoplasms by Histologic Type

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2025

First Posted

February 19, 2025

Study Start

April 1, 2022

Primary Completion

March 30, 2023

Study Completion

December 30, 2023

Last Updated

February 26, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations