- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02433405
Serum Amyloid A Protein And Fetuin A Levels
Serum Amyloid A Protein And Fetuin A Protein Levels In Periodontal Health And Disease
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group 1
Chronic Periodontitis-serum amyloid A, Fetuin-A
|
Acute phase protein
Acute phase protein
|
|
Group 2
Plaque induced Gingivitis-serum amyloid A, Fetuin-A
|
Acute phase protein
Acute phase protein
|
|
Group 3
Control Group-serum amyloid A, Fetuin-A
|
Acute phase protein
Acute phase protein
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Serum Amyloid A (SAA) levels as an inflammatory marker in periodontal disease both in serum and GCF
Time Frame: Day 0
|
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Fetuin-A levels as an inflammatory marker in periodontal disease both in serum and GCF
Time Frame: Day 0
|
Day 0
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: ÇİĞDEM COŞKUN TÜRER, PhD, BULENT ECEVIT UNIVERSITY FACULTY OF DENTISTRY DEPARTMENT OF PERIODONTOLOGY
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAAFA1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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