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

NCT03775967 | Completed DMC

• 1 other identifier: UGD-H-18-10-31-10
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Periodontal Disease

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

Interventions

sialic acid DIAGNOSTIC_TEST

sialic acid level estimation in salivary samples

IL10 DIAGNOSTIC_TEST

IL10 estimation in salivary samples

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• All the subjects should be within the age group of 18 to 55 years
• subject should have atleast 18 natural teeth excluding third molars.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ajman University: lead

Study Sites (1)

AB shetty institute of dental sciences

Mangalore, India

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sialic acid and IL10 are assessed by taking salivary samples

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: December 14, 2018
• Study Start: October 10, 2018
• Primary Completion: January 10, 2019
• Study Completion: February 10, 2019
• Last Updated: November 26, 2019

Record last verified: 2019-11

Locations

IN (1)