Anti Oxidant Enzymes and Total Antioxidant Levels in Diabetes Mellitus Type II Patients and Healthy Individuals With Periodontitis

NCT04180332 | Completed DMC

• 1 other identifier: NU/CEC/Ph.D04/2010
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the role of antioxidants - superoxide dismutase, catalase, glutathione and total anti oxidant levels in the serum of chronic periodontitis patients and chronic periodontitis with DM Type II patients, then to compare it with healthy controls, to assess their possible role as biomarkers for chronic periodontitis and the possible systemic effects of periodontitis.

Conditions

Periodontal Diseases; Diabetes Mellitus; Enzyme Disorder

Keywords

superoxide dismutase; catalase; anti-oxidant; diabetes mellitus; type 2; periodontitis

Outcome Measures

Primary Outcomes (1)

• Catalase estimation

  The estimation will be carried out using ELISA biochemical assay

  From baseline to 5 months

Secondary Outcomes (1)

• Antioxidant estimation

  From baseline to 5 months

Study Arms (3)

Healthy

EXPERIMENTAL

The patients were healthy subjects without Periodontal disease or any systemic manifestation

Diagnostic Test: Blood sample

Periodontal disease without diabetes

EXPERIMENTAL

Patients with periodontal diseases without diabetes

Diagnostic Test: Blood sample

Periodontal disease with diabetes

EXPERIMENTAL

Patients with periodontal disease and diabetes

Diagnostic Test: Blood sample

Interventions

Blood sample DIAGNOSTIC_TEST

5ml of venous blood was taken from the ante cubital vein from each of the study subjects

Healthy; Periodontal disease with diabetes; Periodontal disease without diabetes

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• subjects with chronic periodontitis who did not have any systemic diseases were included in group I
• subjects with chronic periodontitis and diabetes mellitus type II, who were not suffering from any other systemic diseases were included in group II, The diabetic patients in group II were on oral medication (Metformin derivatives) and appropriate diet control measures, for a period of at least one year but not more than five years.
• subjects systemically healthy and not having any periodontal disease were included in group III.

You may not qualify if:

• Subjects were excluded if they had taken antibiotics any time in the last 4 weeks, or taken vitamin and mineral supplements or underwent periodontal treatment procedures in the course of the last 6 months.
• Tobacco users, alcoholics, pregnant as well as lactating women were also excluded from the study.

Sponsors & Collaborators

• Ajman University: lead

Study Sites (1)

AB shetty institute of dental sciences

Mangaluru, India

Location

MeSH Terms

Conditions

Periodontal Diseases; Diabetes Mellitus; Periodontitis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: None were masked
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: cross sectional study

Study Record Dates

• First Submitted: November 23, 2019
• First Posted: November 27, 2019
• Study Start: August 10, 2017
• Primary Completion: August 10, 2018
• Study Completion: August 10, 2018
• Last Updated: November 27, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)