Anti Oxidant Enzymes and Total Antioxidant Levels in Diabetes Mellitus Type II Patients and Healthy Individuals With Periodontitis
Primary Purpose
Periodontal Diseases, Diabetes Mellitus, Enzyme Disorder
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Blood sample
Sponsored by
About this trial
This is an interventional diagnostic trial for Periodontal Diseases focused on measuring superoxide dismutase, catalase, anti-oxidant, diabetes mellitus, type 2, periodontitis
Eligibility Criteria
Inclusion Criteria:
- 100 subjects with chronic periodontitis who did not have any systemic diseases were included in group I
- 100 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.
- 100 subjects systemically healthy and not having any periodontal disease were included in group III.
Exclusion Criteria:
- 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.
Sites / Locations
- AB shetty institute of dental sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Healthy
Periodontal disease without diabetes
Periodontal disease with diabetes
Arm Description
The patients were healthy subjects without Periodontal disease or any systemic manifestation
Patients with periodontal diseases without diabetes
Patients with periodontal disease and diabetes
Outcomes
Primary Outcome Measures
Catalase estimation
The estimation will be carried out using ELISA biochemical assay
Secondary Outcome Measures
Antioxidant estimation
To assess anti-oxidant kevels using ELISA assay
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04180332
Brief Title
Anti Oxidant Enzymes and Total Antioxidant Levels in Diabetes Mellitus Type II Patients and Healthy Individuals With Periodontitis
Official Title
Anti Oxidant Enzymes and Total Antioxidant Levels in Diabetes Mellitus Type II Patients and Healthy Individuals With Periodontitis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
August 10, 2017 (Actual)
Primary Completion Date
August 10, 2018 (Actual)
Study Completion Date
August 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajman University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
This was a cross sectional study involving 300 subjects ,30-60 years of age. 80% was calculated as the power of the study and error was set at 5%. The ethical clearance for the study was obtained from the University central ethics committee. A consent form, was given to all the subjects, which was explained to them and a written consent was taken before enrolling them. As per the prepared case history format, case history was taken for all the subjects who were part of the study The body mass index (BMI) was assessed and subjects who were overweight & obese, with a BMI above 25 , were not included in the study.7 Of the total of 300 subjects,100 subjects who did not have any systemic diseases were included in group I and III, and 100 subjects with 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.
Group I and II patients had chronic generalized severe periodontitis.8 Subjects in group III were systemically healthy and not suffering from any periodontal disease. A single trained investigator examined the periodontal status of all the subjects. Any other type of periodontitis was not included in the study.
Subjects were excluded if they had taken antibiotics any time in the last 4 weeks. Vitamin and mineral supplement intake and those who underwent periodontal treatment procedures in the course of the last 6 months were eliminated from the study. Tobacco users, alcoholics, pregnant as well as lactating women were not included in the study.
Only subjects who had a a RBS score of less than 120 and HbA1c score of less than 7 were accepted in the study.
Then a periodontal examination was carried out, the status of the periodontal condition was determined, and the subjects were alloted to the three groups by the single trained investigator,patient was also referred to a physician to determine the systemic condition.
Following this the patients were allotted to the various groups as per the inclusion criteria. Patients not fulfilling the various criteria were excluded from the study.
5ml of venous blood was taken from the ante cubital vein from each of the study subjects. The blood from each of the subjects was centrifuged and then stored at -20°C. The serum samples were then analysed for the various anti oxidants.
Statistical Analysis Statistical analysis of the data was done using SPSS version 17 software. The comparison of the means of the 2 groups was done using the students 'T' test. Analysis of variance (ANOVA) two tailed test was used to compare the means of more than 2 groups. HSD tukey test with ANOVA jointly,was used to find means that were significantly different from one another. 'p' value (level of significance) less than 0.05 was taken to be statistically significant.
Biochemical Study:
5 ml venous blood which was taken from each study subject was divided into 2 parts. 2 ml of it was collected in EDTA coated vacutainer tubes and 2 ml in plain tubes. The blood in the EDTA coated tubes was used to assess GSH & SOD. The blood in the plain tubes was used to assess the CAT and total antioxidant levels . It was centrifuged and the serum obtained was stored at - 200C for subsequent analysis Superoxide dismutase, glutathione and catalase were assessed by u.v double beam spectrophotometer and total anti-oxidant levels by spectrophotometer.
Total antioxidant capacity of serum was determined by the phosphomolybdenum method . The estimation of superoxide dismutase enzyme was carried out by Beauchamp and Frodovich method. The catalase activity was assessed using the Hydrogen Peroxide reduction method and estimation of glutathione was by the DTNB method.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases, Diabetes Mellitus, Enzyme Disorder
Keywords
superoxide dismutase, catalase, anti-oxidant, diabetes mellitus, type 2, periodontitis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
cross sectional study
Masking
None (Open Label)
Masking Description
None were masked
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy
Arm Type
Experimental
Arm Description
The patients were healthy subjects without Periodontal disease or any systemic manifestation
Arm Title
Periodontal disease without diabetes
Arm Type
Experimental
Arm Description
Patients with periodontal diseases without diabetes
Arm Title
Periodontal disease with diabetes
Arm Type
Experimental
Arm Description
Patients with periodontal disease and diabetes
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood sample
Intervention Description
5ml of venous blood was taken from the ante cubital vein from each of the study subjects
Primary Outcome Measure Information:
Title
Catalase estimation
Description
The estimation will be carried out using ELISA biochemical assay
Time Frame
From baseline to 5 months
Secondary Outcome Measure Information:
Title
Antioxidant estimation
Description
To assess anti-oxidant kevels using ELISA assay
Time Frame
From baseline to 5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
100 subjects with chronic periodontitis who did not have any systemic diseases were included in group I
100 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.
100 subjects systemically healthy and not having any periodontal disease were included in group III.
Exclusion Criteria:
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.
Facility Information:
Facility Name
AB shetty institute of dental sciences
City
Mangaluru
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
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Anti Oxidant Enzymes and Total Antioxidant Levels in Diabetes Mellitus Type II Patients and Healthy Individuals With Periodontitis
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