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

NCT03775967 — Completed, 60 participants, Ajman University

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RegistryNCT03775967
StatusCompleted
Study typeObservational
Enrollment60 (Actual)
SponsorAjman University (Other)
ConditionsPeriodontal Disease
Interventionssialic acid, IL10 (Diagnostic test)
Datesstart 2018-10-10, primary completion 2019-01-10, completion 2019-02-10, first posted 2018-12-14, last updated 2019-11-26
Locations1 site in India

Related Papers Related Patents Related Grants Related Experts
All trials for Periodontal Disease All trials of sialic acid All trials of IL10

-Summary

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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+Detailed description

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.

+Arms and interventions

  • sialic acid (Diagnostic test): sialic acid level estimation in salivary samples
  • IL10 (Diagnostic test): IL10 estimation in salivary samples

+Outcome measures

Primary outcomes

  • Sialic acid levels in stage 1 periodontitis [From baseline to 3 months]: Sialic acid is measured by taking salivary samples(unstimulated) from stage 1 periodontitis patients
  • Sialic acid levels in stage 2 periodontitis [From baseline to 3 months]: Sialic acid is measured by taking salivary samples(unstimulated) from stage 2 periodontitis patients
  • IL10 levels in stage 1 periodontitis [From baseline to 3 months]: IL10 is measured by taking salivary samples(unstimulated) from stage 1 periodontitis patients
  • IL10 levels in stage 2 periodontitis [From baseline to 3 months]: IL10 is measured by taking salivary samples(unstimulated) from stage 2 periodontitis patients

+Eligibility

Sex: All, ages: 18 Years to 55 Years, accepts healthy volunteers

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

+Locations (1)

FacilityCityCountryStatus
AB shetty institute of dental sciencesMangaloreIndia