Periodontal DiseasesVLNCT02615626
Visfatin Levels Before and After Periodontal Treatment
An observational study of Periodontal Diseases, run by Bulent Ecevit University.
Trial summary
The purpose of this study was to evaluate visfatin levels in different stages of periodontal diseases and health, moreover the effect of non-surgical periodontal therapy on visfatin levels in Gingival Crevicular Fluid (GCF) and Serum. Read more about this study
- Who is it for?
- Ages 25 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Non-surgical Periodontal Treatment.
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Jan 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 25 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Total of 45 patients
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: Gingival Crevicular Fluid and Serum Levels of Visfatin in Periodontal Diseases Before and After Non-surgical Periodontal Treatment
The purpose of this study was to evaluate visfatin levels in different stages of periodontal diseases and health, moreover the effect of non-surgical periodontal therapy on visfatin levels in Gingival Crevicular Fluid (GCF) and Serum.
Read the detailed description
Total of 45 patients were divided into three groups based on their clinical and radiographical examination. Group 1 chronic periodontitis (n: 15), group 2 plaque induced gingivitis (n: 15) and group 3 Periodontal health (n: 15). GCF and serum samples were collected before treatment and 1, 3, 6 months after treatment and were assayed using enzyme linked immunosorbent assay kit.
- Conditions
- Periodontal Diseases
- Being tested
- Non-surgical Periodontal Treatment.
- Keywords
- Visfatin, GCF, serum, Non-surgical Periodontal Treatment.
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical Periodontal Treatment.Procedure or surgery
Non-surgical periodontal therapy is an anti-infective therapy which includes both mechanical and chemotherapeutic approaches to minimize or eliminate microbial biofilm, the primary etiology of gingivitis and periodontitis
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Periodontal healthy Receives: Procedure: Non-surgical Periodontal Treatment. | |
| Group 2 | Gingivitis, Non-surgical Periodontal Treatment Receives: Procedure: Non-surgical Periodontal Treatment. | |
| Group 3 | Chronic Periodontitis, Non-surgical Periodontal Treatment Receives: Procedure: Non-surgical Periodontal Treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visfatin levels: Change after periodontal treatment both in serum and GCF
Measured: baseline, 1, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study startMay 2012
- Primary completionOct 2013
- Study completionJan 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 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, Ph.D, Principal investigator, BULENT ECEVIT UNIVERSITY FACULTY OF DENTISTRY DEPARTMENT OF PERIODONTOLOGY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02615626
- Sponsor's protocol ID
- VLandPT
- Acronym
- VL
- Status last verified
- Nov 2015
- First submitted
- 23 Nov 2015
- Last updated
- 26 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gingival Crevicular Fluid and Serum Levels of Visfatin in Periodontal Diseases Before and After Non-surgical Periodontal Treatment
- ClinicalTrials.gov ID
- NCT02615626
- Acronym / sponsor ID
- VL / VLandPT
- Conditions
- Periodontal Diseases
- Keywords
- Visfatin, GCF, serum, Non-surgical Periodontal Treatment.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 26 Nov 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 visfatin levels in different stages of periodontal diseases and health, moreover the effect of non-surgical periodontal therapy on visfatin levels in Gingival Crevicular Fluid (GCF) and Serum.
Detailed description
Total of 45 patients were divided into three groups based on their clinical and radiographical examination. Group 1 chronic periodontitis (n: 15), group 2 plaque induced gingivitis (n: 15) and group 3 Periodontal health (n: 15). GCF and serum samples were collected before treatment and 1, 3, 6 months after treatment and were assayed using enzyme linked immunosorbent assay kit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Non-surgical Periodontal Treatment.Periodontal healthy |
| Group 2 | – | Procedure: Non-surgical Periodontal Treatment.Gingivitis, Non-surgical Periodontal Treatment |
| Group 3 | – | Procedure: Non-surgical Periodontal Treatment.Chronic Periodontitis, Non-surgical Periodontal Treatment |
Who may qualify
- Ages
- 25 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Total of 45 patients
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 |
|---|---|---|
| Non-surgical Periodontal Treatment.Non-surgical periodontal therapy is an anti-infective therapy which includes both mechanical and chemotherapeutic approaches to minimize or eliminate microbial biofilm, the primary etiology of gingivitis and periodontitis | Procedure or surgery | Group 1, Group 2, Group 3 |
Primary outcome
Visfatin levels: Change after periodontal treatment both in serum and GCF
Time frame: baseline, 1, 3 and 6 months
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 26 Nov 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, Ph.D 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 26 Nov 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?
Visfatin levels: Change after periodontal treatment both in serum and GCF (time frame: baseline, 1, 3 and 6 months). 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 26 Nov 2015.