8-Hydroxy-2-Deoxyguanosine ,Total Antioxidant Capacity in Oral Premalignant and Malignant Lesions

NCT03830710 | Completed DMC

• 1 other identifier: 1234
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: Investigating the level of salivary 8-hydroxy-2-deoxyguanosine (8-OHdG) and total antioxidant capacity (TAC) in oral premalignant and malignant lesions in order to determine their diagnostic value for the malignant patients. Design: 120 subjects diagnosed with oral leukoplakia, oral lichen planus (OLP) and oral squamous cell carcinoma (OSCC) along with healthy control subjects were included. Salivary samples from all participants were collected. 8-OHdG was measured by ELISA technique and the TAC level was assessed by a photometric test system.

Conditions

Premalignant Lesion

Keywords

Squamous cell carcinoma; 8-hydroxy-2- deoxyguanosine; Antioxidant

Outcome Measures

Primary Outcomes (2)

• Salivary 8-OHdG

  8-OHdG have a critical role in the pathogenesis of malignant lesions

  1 year

• salivary TAC

  OSCC might be used as a tool to help diagnosis of OSCC but not to differentiate between various malignant grades

  1 year

Study Arms (4)

Group A

30 patients diagnosed with oral leukoplakia

Group B

30 patients diagnosed with oral lichen planus

Group C

30 patients having oral squamous cell carcinoma with the tongue being the most commonly affected site

Group D

30 age and gender matched individuals having no oral mucosal lesions acting as a control group

Eligibility Criteria

• Age: 35 Years - 63 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The included subjects were all assessed medically according to the modified Cornell Medical index (Kerr \& Millard, 1965).

You may qualify if:

• All included individuals were not under any current medication, suffering from any systemic condition or having any other oral mucosal disorder.

You may not qualify if:

• Pregnant or lactating females
• subjects having systemic disorder or taking medications;
• subjects who suffer from any other mucosal lesions.
• severe periodontal inflammation

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

Sandy hassan shaaban

Cairo, Egypt

Location

MeSH Terms

Conditions

Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: February 5, 2019
• Study Start: April 1, 2018
• Primary Completion: October 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 20, 2019

Record last verified: 2019-02

Locations

EG (1)