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CompletedNCT02433405Updated May 5, 2015

Serum Amyloid A Protein And Fetuin A Levels

An observational study in Periodontal Diseases, sponsored by Bulent Ecevit University. Completed. Open to participants aged 28 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-05.

Sponsored by Bulent Ecevit University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
60
Ages
28 Years to 45 Years
Sex
All
01

Study summary

The purpose of this study was to evaluate acute phase proteins (APPs) Fetuin-A and Serum Amyloid A (SAA) levels in gingival crevicular fluid (GCF) and serum samples in periodontal health and disease.

Read the detailed description

The study population consisted totally 60 subjects consulted to Bulent Ecevit University, Faculty of Dentistry, Department of Periodontology whose age and sex were matched.

According to study design, subjects were divided into three groups based on their periodontal parameters. Patients suffering from chronic periodontitis formed the group 1 (n: 20), patients with plaque induced gingivitis formed the group 2 (n:20) and periodontal healthy patients were inserted in group 3 (n:20).

After gently drying the area, GCF was sampled with filter paper using the intracrevicular method (Periopaper, ProFlow, Inc., Amityville, New York, USA).Two milliliters (ml) of peripheral blood was collected from each individual with sterile syringe from the antecubital fossa by venipuncture, and to separate serum component sample centrifuged at 3000g for 5 min, and immediately stored at -40°C until assayed.

The quantity of Fetuin-A and SAA protein concentration in the samples were analyzed by sandwich enzyme-linked immunosorbent assay (ELISA) procedures using commercially available kits.

The Spearman's rank correlation test was used to detect the relationship between GCF and serum SAA and Fetuin-A with GI and CAL. All tests were performed using statistical software (SPSS Inc., version 22.0, Chicago, IL, USA). The mean ± standard deviation with mean rank values were calculated for each parameter, based on the patients as the statistical unit. P \< 0.05 was considered to be statistically significant.

02

Conditions studied

  • Periodontal Diseases

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Keywords

  • Serum Amyloid A
  • Fetuin-A
  • gingival crevicular fluid
  • serum
  • periodontal diseases
03

In context

Periodontal Diseases

855 studies on the registry are indexed under Periodontal Diseases; 189 are open to participants now.

This study's enrollment of 60 is below the median of 100 across 300 observational studies indexed under Periodontal Diseases.

Browse Periodontal Diseases studies →

Lead sponsor

Bulent Ecevit University is the lead sponsor of 47 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
28 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

The study population consisted totally 60 subjects whose age (28-45) and sex (33 men, 27 female) were matched.

Eligibility criteria

Group 1 Inclusion Criteria:

  • GI>1, PPD≥5mm, CAL≥5mm with alveolar bone loss radiographically.
  • Systematically healthy patients

Group 2 Inclusion Criteria:

  • No alveolar bone and attachment loss
  • Inflammation signs such as redness, edema and increased BOP levels,
  • GI≥2, PPD≤3mm, CAL≤3mm.
  • Systematically healthy patients

Group 3 Inclusion Criteria:

  • No bone and attachment loss,
  • GI=0, PPD≤3mm, CAL≤3mm
  • Systematically healthy patients

Exclusion Criteria for all groups:

  • Aggressive Periodontitis,
  • Oral pathologies,
  • Patients with any other systemic diseases,
  • Pregnant women and those in the lactation period,
  • Patients with smoking habit and taking medication
  • Patients received periodontal therapy in last 6 months
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
60 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Group 1

    Chronic Periodontitis-serum amyloid A, Fetuin-A

    Biological: Fetuin-A · Biological: Serum Amyloid A

  • Group 2

    Plaque induced Gingivitis-serum amyloid A, Fetuin-A

    Biological: Fetuin-A · Biological: Serum Amyloid A

  • Group 3

    Control Group-serum amyloid A, Fetuin-A

    Biological: Fetuin-A · Biological: Serum Amyloid A

Interventions

  • BiologicalFetuin-A

    Acute phase protein

  • BiologicalSerum Amyloid A

    Acute phase protein

06

What researchers measure

Primary outcomes

  1. Serum Amyloid A (SAA) levels as an inflammatory marker in periodontal disease both in serum and GCF

    Time frame: Day 0

Secondary outcomes

  1. Fetuin-A levels as an inflammatory marker in periodontal disease both in serum and GCF

    Time frame: Day 0

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02433405
Lead sponsor
Bulent Ecevit University
Responsible party
ÇİĞDEM COŞKUN TÜRER (Dr., Bulent Ecevit University) — Principal investigator
First posted
May 5, 2015
Start date
Dec 2013
Primary completion
Apr 2014
Completion
Nov 2014
Last update
May 5, 2015

Study contacts

ÇİĞDEM COŞKUN TÜRER, PhD
principal investigator · BULENT ECEVIT UNIVERSITY FACULTY OF DENTISTRY DEPARTMENT OF PERIODONTOLOGY

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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