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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03775967
Enrollment
60
Registered
2018-12-14
Start date
2018-10-10
Completion date
2019-02-10
Last updated
2019-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Disease

Keywords

sialic acid, IL10, stage 1 periodontal disease, stage 2 periodontal disease

Brief 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

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.

Interventions

DIAGNOSTIC_TESTsialic acid

sialic acid level estimation in salivary samples

DIAGNOSTIC_TESTIL10

IL10 estimation in salivary samples

Sponsors

Ajman University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
IL10 levels in stage 2 periodontitisFrom baseline to 3 monthsIL10 is measured by taking salivary samples(unstimulated) from stage 2 periodontitis patients
Sialic acid levels in stage 1 periodontitisFrom baseline to 3 monthsSialic acid is measured by taking salivary samples(unstimulated) from stage 1 periodontitis patients
Sialic acid levels in stage 2 periodontitisFrom baseline to 3 monthsSialic acid is measured by taking salivary samples(unstimulated) from stage 2 periodontitis patients
IL10 levels in stage 1 periodontitisFrom baseline to 3 monthsIL10 is measured by taking salivary samples(unstimulated) from stage 1 periodontitis patients

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026