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

Periodontal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03775967
• Other study ID #: UGD-H-18-10-31-10
• Status: Completed
• Start date: October 10, 2018
• Est. completion date: February 10, 2019

Study information

• Verified date: November 2019
• Source: Ajman University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 10, 2019
• Est. primary completion date: January 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontal Disease
• Periodontal Diseases
• Periodontitis

Intervention

Diagnostic Test:
• sialic acid
sialic acid level estimation in salivary samples
• IL10
IL10 estimation in salivary samples

Locations

Country	Name	City	State
India	AB shetty institute of dental sciences	Mangalore

Sponsors (1)

Lead Sponsor	Collaborator
Ajman University

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	IL10 levels in stage 1 periodontitis	IL10 is measured by taking salivary samples(unstimulated) from stage 1 periodontitis patients	From baseline to 3 months
Primary	IL10 levels in stage 2 periodontitis	IL10 is measured by taking salivary samples(unstimulated) from stage 2 periodontitis patients	From baseline to 3 months