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

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ClinicalTrials.gov Identifier: NCT03775967
Recruitment Status : Recruiting
First Posted : December 14, 2018
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
sudhir rama varma, Ajman University

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


Condition or disease Intervention/treatment
Periodontal Disease 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.


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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Estimation of Sialic Acid and IL10 Levels in Stage 1 and 2 Periodontitis Patients
Actual Study Start Date : December 10, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : July 2019

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


Primary Outcome Measures :
  1. Sialic acid levels in stage 1 periodontitis [ Time Frame: From baseline to 3 months ]
    Sialic acid is measured by taking salivary samples(unstimulated) from stage 1 periodontitis patients

  2. Sialic acid levels in stage 2 periodontitis [ Time Frame: From baseline to 3 months ]
    Sialic acid is measured by taking salivary samples(unstimulated) from stage 2 periodontitis patients

  3. IL10 levels in stage 1 periodontitis [ Time Frame: From baseline to 3 months ]
    IL10 is measured by taking salivary samples(unstimulated) from stage 1 periodontitis patients

  4. IL10 levels in stage 2 periodontitis [ Time Frame: From baseline to 3 months ]
    IL10 is measured by taking salivary samples(unstimulated) from stage 2 periodontitis patients


Biospecimen Retention:   Samples Without DNA
Sialic acid and IL10 are assessed by taking salivary samples


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients attending the dental clinics in AB Shetty Institute of Dental sciences,Mangalore
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775967


Contacts
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Contact: sudhir r varma +971506595075 sudhir2002@hotmail.com

Locations
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India
AB shetty institute of dental sciences Recruiting
Mangalore, India
Contact: biju thomas, Phd    919448953418    bijunicy@yahoo.co.uk   
Contact: amitha ramesh, MDS    919448953418    amitha.ramesh@gmail.com   
Sponsors and Collaborators
Ajman University

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Responsible Party: sudhir rama varma, Assistant Professor, Ajman University
ClinicalTrials.gov Identifier: NCT03775967     History of Changes
Other Study ID Numbers: UGD-H-18-10-31-10
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by sudhir rama varma, Ajman University:
sialic acid
IL10
stage 1 periodontal disease
stage 2 periodontal disease

Additional relevant MeSH terms:
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Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases