Clinical trial NCT02433405: Serum Amyloid A Protein And Fetuin A Levels
Official title: Serum Amyloid A Protein And Fetuin A Protein Levels In Periodontal Health And Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Diseases
Keywords: Serum Amyloid A
Fetuin-A
gingival crevicular fluid
serum
periodontal diseases
Lead sponsor: Bulent Ecevit University
Sponsor class: OTHER
First posted: 2015-05-05
Enrollment: 60
Sex: ALL
Minimum age (years): 28
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

Brief 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.

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.

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

Primary outcomes:
measure: Serum Amyloid A (SAA) levels as an inflammatory marker in periodontal disease both in serum and GCF
timeFrame: Day 0
Secondary outcomes:
measure: Fetuin-A levels as an inflammatory marker in periodontal disease both in serum and GCF
timeFrame: Day 0
Other outcomes:
Locations:
Study officials:
affiliation: BULENT ECEVIT UNIVERSITY FACULTY OF DENTISTRY DEPARTMENT OF PERIODONTOLOGY
name: ÇİĞDEM COŞKUN TÜRER, PhD
role: PRINCIPAL_INVESTIGATOR
References: