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Periodontal DiseasesNCT04180332

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

A study testing Blood sample in people with Periodontal Diseases and Diabetes Mellitus, run by Ajman University at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
Blood sample
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteIndia
Study dates
10 Aug 2017to 10 Aug 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

India1 site
  • AB shetty institute of dental sciences

    Mangaluru

Other trials in India

About this study

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.

Read the 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.

Being tested
Blood sample
Keywords
superoxide dismutase, catalase, anti-oxidant, diabetes mellitus, type 2, periodontitis
Medical subject headings
Periodontal Diseases, Diabetes Mellitus, Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood sampleDiagnostic test

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

Study groups in NCT04180332
Study groupRoleWhat they receive
HealthyExperimentalThe patients were healthy subjects without Periodontal disease or any systemic manifestation
Receives: Diagnostic Test: Blood sample
Periodontal disease without diabetesExperimentalPatients with periodontal diseases without diabetes
Receives: Diagnostic Test: Blood sample
Periodontal disease with diabetesExperimentalPatients with periodontal disease and diabetes
Receives: Diagnostic Test: Blood sample

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Catalase estimation

    The estimation will be carried out using ELISA biochemical assay

    Measured: From baseline to 5 months

Secondary outcomes (1)
  1. Antioxidant estimation

    To assess anti-oxidant kevels using ELISA assay

    Measured: From baseline to 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2019
  2. Study start10 Aug 2017
  3. Primary completion10 Aug 2018
  4. Study completion10 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
cross sectional study
Masking
None (open label)
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04180332
Sponsor's protocol ID
NU/CEC/Ph.D04/2010
Status last verified
Nov 2019
First submitted
23 Nov 2019
Last updated
27 Nov 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Blood sample in people with Periodontal Diseases and Diabetes Mellitus, run by Ajman University at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Catalase estimation (time frame: From baseline to 5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2019.

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