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

Sponsor
Fayoum University (Other)
Overall Status
Completed
CT.gov ID
NCT03830710
Collaborator
(none)
120
1
8
15

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Detection of molecular markers in saliva is superior to their detection in serum and other body fluids due to the fact of being an easy non-invasive tool requiring no training for its collection. Consequently, the aim of our work was to investigate salivary 8-OHdG and TAC in premalignant and malignant patients compared to normal subjects and to determine their diagnostic value for the malignant patients.

    Methodology:
    Study population:

    A total of 120 subjects were enrolled in the present study. The clinically tested and confirmed subjects included Group A: 30 patients diagnosed with oral leukoplakia Group B: 30 patients suffering from 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.

    Comprehensive oral diagnosis was done for all participating individuals. Biopsy specimens were obtained from various lesions where a surgical double wedge incisional biopsy was carried out to a depth of about 2mm. Specimens were sent for histopathological examination to confirm the clinical diagnosis.

    Salivary sample collection: Collection of whole unstimulated saliva from all participants was performed using standard techniques.Subjects refrained from eating, drinking, chewing gum etc., for at least ½ h before the evaluation.Samples were collected by asking individuals to swallow first, tilt their head forward and expectorate all saliva in a tube for 5 minutes without swallowing. After collection, all samples were immediately stored at -20ºC until assayed.

    Detection of salivary 8-OHdG: Saliva was centrifuged for 5 minutes at 5000 x g. The supernatant was removed for determination of 8- hydroxy-2'-deoxyguanosine using an ELISA kit provided by BioVision, USA (Catalog # K4160-100). 8-hydroxy-2'-deoxyguanosine is an oxidized derivative of deoxyguanosine and is one of the major products of DNA oxidation.

    Determination of salivary total antioxidative status/capacity (TAS/TAC) was done using ImAnOx (TAS/TAC) Kit provided by Immun Diagnostik, Germany. It is a photometric test system used for the determination of the total antioxidative status/capacity in EDTA-plasma, serum and other biological samples.

    The determination of the antioxidative capacity was performed by the reaction of antioxidants in the sample with a defined amount of exogenously provided hydrogen peroxide (H2O2). The antioxidants in the sample eliminate a certain amount of the provided H2O2. The residual H2O2 was determined photometrically by an enzymatic reaction which involves the conversion of TMB to a colored product. After addition of a stop solution, the samples were measured at 450 nm in a microtiter plate reader. The quantification was performed by the delivered calibrator. The difference between applied and measured peroxide concentration in a defined time period is proportional to the reactivity of the antioxidants of the sample (antioxidative capacity). Quantification was performed with the enclosed calibrator.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    120 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Detection of Salivary 8-Hydroxy-2-Deoxyguanosine and Total Antioxidant Capacity in Patients With Oral Premalignant and Malignant Lesions
    Actual Study Start Date :
    Apr 1, 2018
    Actual Primary Completion Date :
    Oct 1, 2018
    Actual Study Completion Date :
    Dec 1, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Salivary 8-OHdG [1 year]

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

    2. salivary TAC [1 year]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 63 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

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

    Exclusion Criteria:
    1. Pregnant or lactating females

    2. subjects having systemic disorder or taking medications;

    3. subjects who suffer from any other mucosal lesions.

    4. severe periodontal inflammation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sandy hassan shaaban Cairo Egypt

    Sponsors and Collaborators

    • Fayoum University

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Sandy Hassan, lecturer, Fayoum University
    ClinicalTrials.gov Identifier:
    NCT03830710
    Other Study ID Numbers:
    • 1234
    First Posted:
    Feb 5, 2019
    Last Update Posted:
    Feb 20, 2019
    Last Verified:
    Feb 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sandy Hassan, lecturer, Fayoum University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 20, 2019