Periodontal DiseasesNCT02433405
Serum Amyloid A Protein And Fetuin A Levels
An observational study of Periodontal Diseases, run by Bulent Ecevit University.
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. Read more about this study
- Who is it for?
- Ages 28 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Fetuin-A and Serum Amyloid A
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population consisted totally 60 subjects whose age (28-45) and sex (33 men, 27 female) were matched.
Who may be able to join
None listed.
Who cannot join
- 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
About this study
Official title: Serum Amyloid A Protein And Fetuin A Protein Levels In Periodontal Health And Disease
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.
- Conditions
- Periodontal Diseases
- Being tested
- Fetuin-A, Serum Amyloid A
- Keywords
- Serum Amyloid A, Fetuin-A, gingival crevicular fluid, serum, periodontal diseases
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetuin-ABiological
Acute phase protein
Serum Amyloid ABiological
Acute phase protein
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Chronic Periodontitis-serum amyloid A, Fetuin-A Receives: Biological: Fetuin-A; Biological: Serum Amyloid A | |
| Group 2 | Plaque induced Gingivitis-serum amyloid A, Fetuin-A Receives: Biological: Fetuin-A; Biological: Serum Amyloid A | |
| Group 3 | Control Group-serum amyloid A, Fetuin-A Receives: Biological: Fetuin-A; Biological: Serum Amyloid A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Amyloid A (SAA) levels as an inflammatory marker in periodontal disease both in serum and GCF
Measured: Day 0
Secondary outcomes (1)
Fetuin-A levels as an inflammatory marker in periodontal disease both in serum and GCF
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startDec 2013
- Primary completionApr 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ÇİĞDEM COŞKUN TÜRER, Bulent Ecevit University
- Investigators
- ÇİĞDEM COŞKUN TÜRER, PhD, Principal investigator, BULENT ECEVIT UNIVERSITY FACULTY OF DENTISTRY DEPARTMENT OF PERIODONTOLOGY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02433405
- Sponsor's protocol ID
- SAAFA1
- Status last verified
- Apr 2015
- First submitted
- 24 Apr 2015
- Last updated
- 5 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Amyloid A Protein And Fetuin A Protein Levels In Periodontal Health And Disease
- ClinicalTrials.gov ID
- NCT02433405
- Acronym / sponsor ID
- SAAFA1
- Conditions
- Periodontal Diseases
- Keywords
- Serum Amyloid A, Fetuin-A, gingival crevicular fluid, serum, periodontal diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 5 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Biological: Fetuin-A, Biological: Serum Amyloid AChronic Periodontitis-serum amyloid A, Fetuin-A |
| Group 2 | – | Biological: Fetuin-A, Biological: Serum Amyloid APlaque induced Gingivitis-serum amyloid A, Fetuin-A |
| Group 3 | – | Biological: Fetuin-A, Biological: Serum Amyloid AControl Group-serum amyloid A, Fetuin-A |
Who may qualify
- Ages
- 28 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population consisted totally 60 subjects whose age (28-45) and sex (33 men, 27 female) were matched.
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fetuin-AAcute phase protein | Biological | Group 1, Group 2, Group 3 |
| Serum Amyloid AAcute phase protein | Biological | Group 1, Group 2, Group 3 |
Primary outcome
Serum Amyloid A (SAA) levels as an inflammatory marker in periodontal disease both in serum and GCF
Time frame: Day 0
1 secondary outcome
Fetuin-A levels as an inflammatory marker in periodontal disease both in serum and GCF
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ÇİĞDEM COŞKUN TÜRER, PhD principal investigator
BULENT ECEVIT UNIVERSITY FACULTY OF DENTISTRY DEPARTMENT OF PERIODONTOLOGY
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Diseases, run by Bulent Ecevit University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Amyloid A (SAA) levels as an inflammatory marker in periodontal disease both in serum and GCF (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2015.