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

Study Overview

• Status: Completed
• Conditions: Periodontal Disease
• Intervention / Treatment: Diagnostic test: sialic acid; Diagnostic test: IL10

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• India
  • Mangalore, India
    • AB shetty Institute of dental sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients attending the dental clinics in AB Shetty Institute of Dental sciences,Mangalore

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sialic acid levels in stage 1 periodontitis	Sialic acid is measured by taking salivary samples(unstimulated) from stage 1 periodontitis patients	From baseline to 3 months
Sialic acid levels in stage 2 periodontitis	Sialic acid is measured by taking salivary samples(unstimulated) from stage 2 periodontitis patients	From baseline to 3 months
IL10 levels in stage 1 periodontitis	IL10 is measured by taking salivary samples(unstimulated) from stage 1 periodontitis patients	From baseline to 3 months
IL10 levels in stage 2 periodontitis	IL10 is measured by taking salivary samples(unstimulated) from stage 2 periodontitis patients	From baseline to 3 months

Collaborators and Investigators

• Sponsor: Ajman University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 10, 2018
• Primary Completion (ACTUAL): January 10, 2019
• Study Completion (ACTUAL): February 10, 2019

Study Registration Dates

• First Submitted: December 12, 2018
• First Submitted That Met QC Criteria: December 13, 2018
• First Posted (ACTUAL): December 14, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 26, 2019
• Last Update Submitted That Met QC Criteria: November 23, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: IL10; sialic acid; stage 1 periodontal disease; stage 2 periodontal disease
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontitis; Periodontal Diseases
• Other Study ID Numbers: UGD-H-18-10-31-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No