Periodontal DiseasesNCT03507868
YKL-40 and IL-6 Levels in Periodontal Disease
An observational study of Periodontal Diseases, run by Zeynep Pinar KELES.
Trial summary
The primer aim of the study was to investigate saliva and gingival crevicular fluid (GCF) YKL-40 and also interleukin-6 (IL-6) levels in chronic periodontitis pathogenesis. Read more about this study
- Who is it for?
- Ages 26 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Nonsurgical periodontal therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Jan 2018
- 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 26 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: A total of 52 participants
Who may be able to join
- Group 1 Inclusion Criteria:
- No bone and attachment loss,
- GI=0, PPD≤3mm, CAL≤3mm
- Systematically healthy patients
- Group 2 Inclusion Criteria:
- GI>1, PPD≥5mm, CAL≥5mm with alveolar bone loss radiographically.
- Systematically healthy patients
Who cannot join
- Aggressive Periodontitis,
- 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 month
About this study
Official title: Effect of Non-Surgical Periodontal Therapy on Salivary and Gingival Crevicular Fluid YKL-40 and IL-6 Levels in Chronic Periodontitis
The primer aim of the study was to investigate saliva and gingival crevicular fluid (GCF) YKL-40 and also interleukin-6 (IL-6) levels in chronic periodontitis pathogenesis.
Read the detailed description
This study consisted of two groups: 26 periodontally healthy individuals and 26 generalized chronic periodontitis patients. Chronic periodontitis patients were received nonsurgical periodontal treatment. Clinical measurements were recorded, saliva and GCF samples were obtained before and at first and third months after periodontal therapy. Levels of YKL-40 and IL-6 in saliva and GCF were analyzed by enzyme-linked immunosorbent assay.
- Conditions
- Periodontal Diseases
- Being tested
- Nonsurgical periodontal therapy
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nonsurgical periodontal therapyProcedure or surgery
Nonsurgical periodontal therapy includes oral hygiene education and scaling and root planning approaches to eliminate microbial dental plaque that is the primary etiology of periodontal diseases.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Periodontally healthy individuals | |
| Group 2 | Chronic periodontitis patients Receives: Procedure: Nonsurgical periodontal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
YKL-40 levels
changes in YKL-40 levels after periodontal therapy
Measured: at first and third month after therapy
Secondary outcomes (1)
IL-6 levels
changes in IL-6 levels after periodontal therapy
Measured: at first and third month after therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study startSep 2016
- Primary completionApr 2017
- Study completionJan 2018
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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeynep Pinar KELES
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zeynep Pinar KELES, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507868
- Sponsor's protocol ID
- 2016/1003
- Status last verified
- Apr 2018
- First submitted
- 16 Apr 2018
- Last updated
- 25 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-Surgical Periodontal Therapy on Salivary and Gingival Crevicular Fluid YKL-40 and IL-6 Levels in Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT03507868
- Acronym / sponsor ID
- 2016/1003
- Conditions
- Periodontal Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Zeynep Pinar KELESUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 25 Apr 2018 (actual)
- 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 investigate saliva and gingival crevicular fluid (GCF) YKL-40 and also interleukin-6 (IL-6) levels in chronic periodontitis pathogenesis.
Detailed description
This study consisted of two groups: 26 periodontally healthy individuals and 26 generalized chronic periodontitis patients. Chronic periodontitis patients were received nonsurgical periodontal treatment. Clinical measurements were recorded, saliva and GCF samples were obtained before and at first and third months after periodontal therapy. Levels of YKL-40 and IL-6 in saliva and GCF were analyzed by enzyme-linked immunosorbent assay.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Periodontally healthy individuals |
| Group 2 | – | Procedure: Nonsurgical periodontal therapyChronic periodontitis patients |
Who may qualify
- Ages
- 26 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A total of 52 participants
Key inclusion criteria (7 listed)
- No bone and attachment loss,
- GI=0, PPD≤3mm, CAL≤3mm
- Systematically healthy patients
- GI>1, PPD≥5mm, CAL≥5mm with alveolar bone loss radiographically.
- Systematically healthy patients
Key exclusion criteria (5 listed)
- Aggressive Periodontitis,
- 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 month
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 |
|---|---|---|
| Nonsurgical periodontal therapyNonsurgical periodontal therapy includes oral hygiene education and scaling and root planning approaches to eliminate microbial dental plaque that is the primary etiology of periodontal diseases. | Procedure or surgery | Group 2 |
Primary outcome
YKL-40 levels
Time frame: at first and third month after therapy
changes in YKL-40 levels after periodontal therapy
1 secondary outcome
IL-6 levels
Time frame: at first and third month after therapy
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 25 Apr 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Diseases, run by Zeynep Pinar KELES.
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 7 inclusion and 5 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 25 Apr 2018. 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?
YKL-40 levels (time frame: at first and third month after therapy). 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 25 Apr 2018.