Colposcopy in Detection of Oral Epithelial Dysplasia

Cairo University (CU)

Status: Unknown

Conditions: Intraepithelial Carcinoma

Treatments: Device: Digital colposcope

Study type: Interventional

Funder types: Other

Identifiers

NCT03075098

CEBD-CU-2017-03-1

Details and patient eligibility

About

The aim of this work is to detect the diagnostic accuracy of the intra-oral application of colposcope in diagnosing oral dysplastic lesions in comparison to biopsy taking and histopathological examination.

Full description

A- Roles and Responsibilities:

1. The Principle Supervisor: Dr. Mohsen Kazem (M.K.), Professor of Oral &Maxillofacial Pathology, Cairo University, will examine the taken biopsy histopathologically and determine the definitive diagnosis.
2. The Assistant Supervisor: Dr. Heba Dahmoush (H.D.), Professor of Oral & Maxillofacial Pathology, Cairo University, will examine the taken biopsy histopathologically and determine the definitive diagnosis.
3. The Principle Investigator: Sarah Ahmed Mohamed Mahmoud Badawy (S.B.), Assistant Lecturer of Oral &Maxillofacial Pathology, Cairo University, will read and put a colposcopic score for each participant individually.
4. Eman Desouky (E.D.) Sample size calculation; Statistician, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
5. Evidence Based Committee, Faculty of Dentistry, Cairo University: Help in reporting study protocol following STARD guidelines.
6. Ethics Committee, Faculty of Dentistry, Cairo University: Protocol reviewer of the diagnostic accuracy study in order to protect the right, safety, dignity and well-being of the participants.

B- Index test: The principle investigator (S.B.) will perform the index test using Digital Electronic Colposcope (Kernel, KN-2200, China). Before taking up the patients for Colposcopic evaluation and giving them a score, the normal Colposcopic findings will be standardized based on the Colposcopic criteria. Colposcopic criteria includes aceto uptake, surface pattern and clarity of demarcation of the mucosal lesions, vascular pattern, lesion size as well as Iodine staining.

C- Reference test:The reference standard; to reach a definitive diagnosis in oral dysplastic lesions, will be a representative biopsy and histopathological examination. M.K. and H.D. will examine the taken biopsy histopathologically, determine the definitive diagnosis and write the diagnosis in the Assessor chart.

Inclusion criteria:

• Patients seeking for diagnosis of clinically suspected oral dysplastic Leukoplakia or Erythroplakia
• Patients seeking for diagnosis of clinically suspected oral Carcinoma.

Exclusion criteria:

• Patients with secondary infection.
• Patients having other systemic diseases.
• Patients undergoing treatment for the lesions.

Enrollment: 25 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients seeking for diagnosis of clinically suspected oral dysplastic Leukoplakia or Erythroplakia
• Patients seeking for diagnosis of clinically suspected oral Carcinoma.

Exclusion criteria

• Patients with secondary infection.
• Patients having other systemic diseases.
• Patients undergoing treatment for the lesions.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

25 participants in 1 patient group

colposcopy of intraepithelial carcinoma

Experimental group

Description:

Digital colposcope will be used to detect the swede score of the lesion

Treatment:

Device: Digital colposcope