Serum Amyloid A Protein And Fetuin A Levels

Periodontal Diseases Clinical Trial

Official title:

Serum Amyloid A Protein And Fetuin A Protein Levels In Periodontal Health And Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02433405
• Other study ID #: SAAFA1
• Status: Completed
• Phase: Phase 0
• First received: April 24, 2015
• Last updated: April 29, 2015
• Start date: December 2013
• Est. completion date: November 2014

Study information

• Verified date: April 2015
• Source: Bulent Ecevit University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 28 Years to 45 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Gingival Diseases
• Periodontal Diseases

Intervention

Biological:
• Fetuin-A
Acute phase protein
• Serum Amyloid A
Acute phase protein

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bulent Ecevit University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Amyloid A (SAA) levels as an inflammatory marker in periodontal disease both in serum and GCF		Day 0	Yes
Secondary	Fetuin-A levels as an inflammatory marker in periodontal disease both in serum and GCF		Day 0	Yes