Periodontal DiseaseNCT02750956
Endocan, VEGF and TNF-alpha Levels in Periodontal Disease and After Treatment
An observational study of Periodontal Disease, run by Bulent Ecevit University.
Trial summary
The primer aim of the study was to determine serum and gingival crevicular fluid (GCF) endocan levels in periodontal diseases pathogenesis supported with vascular endothelial growth factor (VEGF) and tumor necrosis factor alpha (TNF-α) levels. Read more about this study
- Who is it for?
- Ages 25 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Disease
- What is being tested?
- Non-surgical periodontal treatment
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Mar 2016
- 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 40 individuals
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: Effect of Non-surgical Periodontal Treatment on Gingival Crevicular Fluid and Serum Endocan, Vascular Endothelial Growth Factor-A and Tumor Necrosis Factor Alpha Levels
The primer aim of the study was to determine serum and gingival crevicular fluid (GCF) endocan levels in periodontal diseases pathogenesis supported with vascular endothelial growth factor (VEGF) and tumor necrosis factor alpha (TNF-α) levels.
Read the detailed description
The study consist of three groups: periodontally healthy individuals (group 1; n = 20), individuals with generalized chronic periodontitis (group 2; n = 20), the same patients with chronic periodontitis after they had been treated with scaling and root planing (SRP) were considered as Group 3. Clinical measurements were recorded; GCF and serum samples were obtained from each participant before and 6 weeks after therapy. Endocan, VEGF-A and TNF-α levels were measured by enzyme-linked immunosorbent assay.
- Conditions
- Periodontal Disease
- Being tested
- Non-surgical periodontal treatment
- Keywords
- endocan protein, VEGF A, TNF-alpha, after 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 treatmentProcedure 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 individuals | |
| Group 2 | Patients with chronic periodontitis Receives: Procedure: Non-surgical periodontal treatment | |
| Group 3 | the same patients in group 2 after they had been treated with scaling and root planing (SRP) were considered as Group 3. Receives: Procedure: Non-surgical periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endocan levels
Change after periodontal treatment
Measured: 6 weeks
Secondary outcomes (2)
VEGF levels
Change after periodontal treatment
Measured: 6 weeks
TNF-alpha levels
Change after periodontal treatment
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startJun 2015
- Primary completionDec 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies 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
- 40 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, Principal investigator, BULENT ECEVIT UNIVERSITY FACULTY OF DENTISTRY DEPARTMENT OF PERIODONTOLOGY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02750956
- Sponsor's protocol ID
- Endocan
- Status last verified
- Apr 2016
- First submitted
- 19 Apr 2016
- Last updated
- 26 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-surgical Periodontal Treatment on Gingival Crevicular Fluid and Serum Endocan, Vascular Endothelial Growth Factor-A and Tumor Necrosis Factor Alpha Levels
- ClinicalTrials.gov ID
- NCT02750956
- Acronym / sponsor ID
- Endocan
- Conditions
- Periodontal Disease
- Keywords
- endocan protein, VEGF A, TNF-alpha, after treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 26 Apr 2016 (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 primer aim of the study was to determine serum and gingival crevicular fluid (GCF) endocan levels in periodontal diseases pathogenesis supported with vascular endothelial growth factor (VEGF) and tumor necrosis factor alpha (TNF-α) levels.
Detailed description
The study consist of three groups: periodontally healthy individuals (group 1; n = 20), individuals with generalized chronic periodontitis (group 2; n = 20), the same patients with chronic periodontitis after they had been treated with scaling and root planing (SRP) were considered as Group 3. Clinical measurements were recorded; GCF and serum samples were obtained from each participant before and 6 weeks after therapy. Endocan, VEGF-A and TNF-α levels were measured by enzyme-linked immunosorbent assay.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Periodontal healthy individuals |
| Group 2 | – | Procedure: Non-surgical periodontal treatmentPatients with chronic periodontitis |
| Group 3 | – | Procedure: Non-surgical periodontal treatmentthe same patients in group 2 after they had been treated with scaling and root planing (SRP) were considered as Group 3. |
Who may qualify
- Ages
- 25 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Total of 40 individuals
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 treatmentNon-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 2, Group 3 |
Primary outcome
Endocan levels
Time frame: 6 weeks
Change after periodontal treatment
2 secondary outcomes
VEGF levels
Time frame: 6 weeks
TNF-alpha levels
Time frame: 6 weeks
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 Apr 2016.
- Individual participant dataSharing planned: No
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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 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 Disease, 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 Apr 2016. 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?
Endocan levels (time frame: 6 weeks). 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 Apr 2016.