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

NCT ID: NCT03775967

Last Updated: 2019-11-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-10
• Study Completion Date: 2019-02-10

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.

Conditions

Periodontal Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

sialic acid

sialic acid level estimation in salivary samples

Intervention Type: DIAGNOSTIC_TEST

IL10

IL10 estimation in salivary samples

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ajman University

OTHER

Sponsor Role: lead

Responsible Party

sudhir rama varma

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

AB shetty institute of dental sciences

Mangalore, , India

Countries

India

Other Identifiers

UGD-H-18-10-31-10

Identifier Type: -

Identifier Source: org_study_id