Periodontal DiseasesGCFNCT05325905
Analysis of Gingival Crevicular Fluid
An observational study of Periodontal Diseases, run by Bezmialem Vakif University.
Trial summary
The purpose of this study was to investigate and compare GCF interleukin-1β (IL-1β), interleukin-10 (IL-10), interleukin-36γ (IL-36γ) levels in patients with healthy (H), gingivitis (G) and chronic periodontitis (CP) status. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Gingival crevicular fluid sampling
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Jan 2017
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients were selected from among admitting to Dentistry Faculty of Selcuk University.
Who may be able to join
- Systemically healthy
- non-smokers,
- presence of at least 20 teeth in the mouth
Who cannot join
- receiving periodontal therapy in the last 6 months;
- receiving antibiotics or anti-inflammatory drugs in the last 6 months;
- currently pregnant or breastfeeding
- using a removable partial denture and removable or fixed orthodontic appliances.
About this study
Official title: Analysis of Gingival Crevicular Fluid IL-1β, IL-10, IL-36γ Cytokine Levels in Gingivitis and Periodontitis Patients
The purpose of this study was to investigate and compare GCF interleukin-1β (IL-1β), interleukin-10 (IL-10), interleukin-36γ (IL-36γ) levels in patients with healthy (H), gingivitis (G) and chronic periodontitis (CP) status.
Read the detailed description
Gingival crevicular fluid (GCF) is formed when fluid exudes from the vessels of the microcirculation into the inflamed periodontal tissue and into the sulcus or pocket. As the fluid traverses the inflamed tissue, it is thought to pick up enzymes and other molecules that participate in the destructive process, as well as products of cell and tissue degradation. Efforts to develop diagnostic tests based on host factors have been focused almost entirely on analysis of GCF.
The purpose of this study was to investigate and compare GCF interleukin-1β (IL-1β), interleukin-10 (IL-10), interleukin-36γ (IL-36γ) levels in patients with healthy (H), gingivitis (G) and chronic periodontitis (CP) status.
Systemically healthy and non-smokers 80 participants (30 males and 50 females) who were selected from among admitting to Dentistry Faculty of Selcuk University were included in this study. Clinical periodontal parameters were recorded and GCF samples were obtained. Samples were stored in -80 ˚C until analysis with Enzyme-Linked ImmunoSorbent Assay (ELISA).
- Conditions
- Periodontal Diseases
- Being tested
- Gingival crevicular fluid sampling
- Keywords
- pathogenesis, Gingival crevicular fluid, cytokine
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gingival crevicular fluid samplingDiagnostic test
GCF sampling and clinical periodontal measurements were performed
| Study group | Role | What they receive |
|---|---|---|
| Healthy | bleeding on probing (BoP) ≤ 10% of the sites, probing depth (PD) ≤ 3 mm and no indication of clinical attachment level (CAL) or radiographic bone loss Receives: Diagnostic Test: Gingival crevicular fluid sampling | |
| Gingivitis | gingival inflammation (BoP ≥ 10% of the sites, red-blue discoloration of the gingiva and edema) PD ≤ 4 mm and no clinical attachment or radiographic bone loss Receives: Diagnostic Test: Gingival crevicular fluid sampling | |
| Periodontitis | PD ≤ 5 mm, radiographic bone loss, and 3-4 mm CAL in at least 30% of the sites Receives: Diagnostic Test: Gingival crevicular fluid sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin-36γ (IL-36γ) levels in GCF
GCF samples were obtained from one interproximal site in each quadrant
Measured: Baseline
Secondary outcomes (6)
Probing depth (PD)
PD; from six sites (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual locations) of each tooth other than third molars.
Measured: Baseline
Clinical attachment level (CAL)
CAL; from six sites (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual locations) of each tooth other than third molars.
Measured: Baseline
Bleeding on Probing (BoP)
BoP, from six sites (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual locations) of each tooth other than third molars
Measured: Baseline
IL-10 and IL-1β levels in GCF
GCF samples were obtained from one interproximal site in each quadrant
Measured: Baseline
Plaque Index (PI)
PI; from six sites (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual locations) of each tooth other than third molars
Measured: Baseline
Gingival Index (GI)
GI; from six sites (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual locations) of each tooth other than third molars
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study startOct 2014
- Primary completionApr 2016
- Study completionJan 2017
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.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Collaborators
- Selcuk University
- Responsible party
- Principal investigator, Mehtikar Gursel, Bezmialem Vakif University
- Investigators
- Mehtikar Gürsel, Principal investigator, Bezmialem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325905
- Sponsor's protocol ID
- 2014/01
- Acronym
- GCF
- Status last verified
- Apr 2022
- First submitted
- 6 Apr 2022
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results will be shared if requested
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Gingival Crevicular Fluid IL-1β, IL-10, IL-36γ Cytokine Levels in Gingivitis and Periodontitis Patients
- ClinicalTrials.gov ID
- NCT05325905
- Acronym / sponsor ID
- GCF / 2014/01
- Conditions
- Periodontal Diseases
- Keywords
- pathogenesis, Gingival crevicular fluid, cytokine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Collaborators
- Selcuk University
- Study start
- Oct 2014 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 13 Apr 2022 (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 purpose of this study was to investigate and compare GCF interleukin-1β (IL-1β), interleukin-10 (IL-10), interleukin-36γ (IL-36γ) levels in patients with healthy (H), gingivitis (G) and chronic periodontitis (CP) status.
Detailed description
Gingival crevicular fluid (GCF) is formed when fluid exudes from the vessels of the microcirculation into the inflamed periodontal tissue and into the sulcus or pocket. As the fluid traverses the inflamed tissue, it is thought to pick up enzymes and other molecules that participate in the destructive process, as well as products of cell and tissue degradation. Efforts to develop diagnostic tests based on host factors have been focused almost entirely on analysis of GCF.
The purpose of this study was to investigate and compare GCF interleukin-1β (IL-1β), interleukin-10 (IL-10), interleukin-36γ (IL-36γ) levels in patients with healthy (H), gingivitis (G) and chronic periodontitis (CP) status.
Systemically healthy and non-smokers 80 participants (30 males and 50 females) who were selected from among admitting to Dentistry Faculty of Selcuk University were included in this study. Clinical periodontal parameters were recorded and GCF samples were obtained. Samples were stored in -80 ˚C until analysis with Enzyme-Linked ImmunoSorbent Assay (ELISA).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Diagnostic Test: Gingival crevicular fluid samplingbleeding on probing (BoP) ≤ 10% of the sites, probing depth (PD) ≤ 3 mm and no indication of clinical attachment level (CAL) or radiographic bone loss |
| Gingivitis | – | Diagnostic Test: Gingival crevicular fluid samplinggingival inflammation (BoP ≥ 10% of the sites, red-blue discoloration of the gingiva and edema) PD ≤ 4 mm and no clinical attachment or radiographic bone loss |
| Periodontitis | – | Diagnostic Test: Gingival crevicular fluid samplingPD ≤ 5 mm, radiographic bone loss, and 3-4 mm CAL in at least 30% of the sites |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were selected from among admitting to Dentistry Faculty of Selcuk University.
Key inclusion criteria (3 listed)
- Systemically healthy
- non-smokers,
- presence of at least 20 teeth in the mouth
Key exclusion criteria (4 listed)
- receiving periodontal therapy in the last 6 months;
- receiving antibiotics or anti-inflammatory drugs in the last 6 months;
- currently pregnant or breastfeeding
- using a removable partial denture and removable or fixed orthodontic appliances.
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 |
|---|---|---|
| Gingival crevicular fluid samplingGCF sampling and clinical periodontal measurements were performed | Diagnostic test | Gingivitis, Healthy, Periodontitis |
Primary outcome
Interleukin-36γ (IL-36γ) levels in GCF
Time frame: Baseline
GCF samples were obtained from one interproximal site in each quadrant
6 secondary outcomes
Probing depth (PD)
Time frame: Baseline
Clinical attachment level (CAL)
Time frame: Baseline
Bleeding on Probing (BoP)
Time frame: Baseline
IL-10 and IL-1β levels in GCF
Time frame: Baseline
Plaque Index (PI)
Time frame: Baseline
Gingival Index (GI)
Time frame: Baseline
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 13 Apr 2022.
- Individual participant dataSharing planned: No. Results will be shared if requested
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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.
Mehtikar Gürsel principal investigator
Bezmialem University
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Diseases, run by Bezmialem Vakif 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 3 inclusion and 4 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 13 Apr 2022. 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?
Interleukin-36γ (IL-36γ) levels in GCF (time frame: Baseline). 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 13 Apr 2022.