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NCT Number: NCT03775967

Estimation of Sialic Acid and IL10 Levels in Stage 1 and 2 Periodontitis Patients

Sialic acid (SA) is the generic term given to a family of acetylated derivatives of neuraminic acid. SA is a 9 carbon monosaccharide. An important function of host SA is to regulate innate immunity. SA is present in several acute phase proteins which are known to be associated with periodontitis. There exists a need for a biomarker, for early detection of disease evolution and more robust therapy efficacy measurements. Till date, there is very little data regarding simultaneous estimation and comparison of total SA content in saliva. IL-10, an anti-inflammatory cytokine, regulates the synthesis of pro-inflammatory cytokines such as IL-1, -2, -6 and stimulates protective antibody production. IL-10 is expressed in both healthy and diseased human periodontal tissues and is reported to be reduced in patients infected with Aggregatibacter actinomycetemcomitans.

The present study was therefore undertaken with an aim, to not only assess the levels of TSA(Total sialic acid levels),but also of IL 10 levels in saliva from stage 1(mild) to stage 2(moderate) periodontitis patients

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Key information

Conditions

Periodontal Disease Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

AB shetty institute of dental sciences

Mangalore, India

About this study

Selection of patients by grading the patients according to criteria stage 1 and 2 Periodontitis

Obtaining consent from patients participating in the study

Collection of saliva-unstimulated whole saliva, the samples will be stored at -20 degree Centigrade and later placed in a 1.5ml centrifuge tubes which will be placed in a vacuum cool box indicated for laboratory samples and transported to the lab for investigations. It will be centrifuged at 2500 rpm for 10 mins,stored at -80 deg C. SA(sialic acid) levels will be determined by thiobarbutic acid method of aminoff and ELISA methods. SA levels will be measured in mg/dl,IL10 as in direct measurement.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All the subjects should be within the age group of 18 to 55 years
  • subject should have atleast 18 natural teeth excluding third molars.

Exclusion criteria

  • History of periodontal debridement or periodontal surgery in preceding six months or any antimicrobial therapy, anti-inflammatory drugs.
  • corticosteroids, in previous three months
  • systemically compromised individuals
  • smokers
  • pregnant and lactating women
  • Medical history for absence of systemic disorders such as diabetes mellitus
  • cardiovascular diseases
  • pneumonia
  • tuberculosis
  • rheumatoid arthritis

Treatment and study plan

sialic acid

Diagnostic Test

sialic acid level estimation in salivary samples

IL10

Diagnostic Test

IL10 estimation in salivary samples

Primary outcomes

  1. Sialic acid levels in stage 1 periodontitis

    Time frame: From baseline to 3 months

    Sialic acid is measured by taking salivary samples(unstimulated) from stage 1 periodontitis patients

  2. Sialic acid levels in stage 2 periodontitis

    Time frame: From baseline to 3 months

    Sialic acid is measured by taking salivary samples(unstimulated) from stage 2 periodontitis patients

  3. IL10 levels in stage 1 periodontitis

    Time frame: From baseline to 3 months

    IL10 is measured by taking salivary samples(unstimulated) from stage 1 periodontitis patients

  4. IL10 levels in stage 2 periodontitis

    Time frame: From baseline to 3 months

    IL10 is measured by taking salivary samples(unstimulated) from stage 2 periodontitis patients

Sponsors and collaborators

Lead sponsor

Ajman University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 14, 2018
Registry last updated
Nov 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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