Clinical trial NCT03775967: Estimation of Sialic Acid and IL10 Levels in Stage 1 and 2 Periodontitis Patients
Official title: Estimation of Sialic Acid and IL10 Levels in Stage 1 and 2 Periodontitis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Disease
Keywords: sialic acid
IL10
stage 1 periodontal disease
stage 2 periodontal disease
Lead sponsor: Ajman University
Sponsor class: OTHER
First posted: 2018-12-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients attending the dental clinics in AB Shetty Institute of Dental sciences,Mangalore

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.

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

Primary outcomes:
measure: Sialic acid levels in stage 1 periodontitis
timeFrame: From baseline to 3 months
measure: Sialic acid levels in stage 2 periodontitis
timeFrame: From baseline to 3 months
measure: IL10 levels in stage 1 periodontitis
timeFrame: From baseline to 3 months
measure: IL10 levels in stage 2 periodontitis
timeFrame: From baseline to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mangalore
country: India
facility: AB shetty institute of dental sciences
Study officials:
References: