Periodontal DiseasesNCT04777487
Evaluation of Biomarker Levels in Gingival Crevicular Fluid of Patients With Different Periodontal Diseases
A study testing GCF obtaining in people with Periodontal Diseases, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
Objectives: The aim of this study is; detection of peptidyl arginine deiminase4 (PAD4), galectin-3 and tumor necrosis factor alpha (TNF-α) levels in gingival crevicular fluid (GCF) samples of periodontally healthy, gingivitis and periodontitis patients and the possible correlation between these values and clinical… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- GCF obtaining
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2019to 25 Sep 2019
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy (The determination of healthy volunteers will be based on the statements of the patients in the anamnesis. No additional examinations will be made.)
- At least twenty permanent teeth in the mouth
- Non-smoker
- No medication for continuous use
- Those who have not used antibiotics, anti-inflammatory and systemic corticosteroid drugs in the last 6 months.
- Not in pregnancy or lactation period.
Show all 10Show fewer
- For the periodontitis group that has not received periodontal treatment in the last 6 months
- For the periodontitis group; According to the evaluation made in 6 regions of each tooth, individuals with 30% or more bleeding on probing area, at least 2 teeth not adjacent to each quarter jaw with a depth of 5 mm or more and 4 mm or more attachment loss, coronal 1/3 and more on radiography (horizontal and / or vertical) bone loss
- For the gingivitis group; According to the evaluation made in 6 regions of each tooth, individuals with 10% or more bleeding on probing area, having a probing depth of less than 4mm and no attachment loss
- For healthy group; According to the evaluation made in 6 regions of each tooth,individuals with less than 10% bleeding on probing area, having a probing depth less than 4mm and no loss of attachment were included in the study.
Who cannot join
- Any oral or systemic disease
- Regularly using a systemic medication
- During pregnancy or lactation
- Received periodontal treatment within the last 6 months.
- Those who received antibiotic, anti-inflammatory or systemic corticosteroid medication in the last 6 months
- Smokers are not included in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Katip Çelebi University Department of Periodontology
Izmir
About this study
Official title: Evaluation of Peptidyl Arginine Deiminase 4 (PAD4), Galectin-3 and TNF-α Levels in Gingival Crevicular Fluid of Patients With Different Periodontal Diseases
Objectives: The aim of this study is; detection of peptidyl arginine deiminase4 (PAD4), galectin-3 and tumor necrosis factor alpha (TNF-α) levels in gingival crevicular fluid (GCF) samples of periodontally healthy, gingivitis and periodontitis patients and the possible correlation between these values and clinical parameters of periodontal diseases. Materials and methods: Samples of GCF were obtained from 60systemically healthy non-smoker individuals with periodontitis (P, n=20), gingivitis(G, n=20) and healthy periodontium (S, n=20). Full-mouth clinical periodontal measurements including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), gingival index (GI) and plaque index (PI) were also recorded. Enzyme-linked immunosorbent assay (ELISA) was used to determine PAD4, galectin-3 and TNF-α levels in the biological samples.
- Conditions
- Periodontal Diseases
- Being tested
- GCF obtaining
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GCF obtainingDiagnostic test
4 samples of gingival crevicular fluid, 1 from each quadrant of the patient's jaw, were collected by means of paper strips.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Periodontium | Experimental | Full-mouth clinical periodontal measurements recorded and GCF obtained. Receives: Diagnostic Test: GCF obtaining |
| Gingivitis | Experimental | Full-mouth clinical periodontal measurements recorded and GCF obtained. Receives: Diagnostic Test: GCF obtaining |
| Periodontitis | Experimental | Full-mouth clinical periodontal measurements recorded and GCF obtained. Receives: Diagnostic Test: GCF obtaining |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total amount of Galectin-3 in GCF
The total amount of Galectin-3 in GCF
Measured: 24 hours after taking the clinical measurements at the first visit
The total amount of PAD4 in GCF
The total amount of PAD4 in GCF
Measured: 24 hours after taking the clinical measurements at the first visit
Secondary outcomes (1)
The total amount of TNF-α in GCF
The total amount of TNF-α in GCF
Measured: 24 hours after taking the clinical measurements at the first visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start1 Apr 2019
- Primary completion25 Sep 2019
- Study completion25 Sep 2019
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- According to full-mouth clinical periodontal measurements including probing depth (PD), clinical attachment level (CAL),bleeding on probing (BOP), gingival index (GI) and plaque index (PI) samples of GCF were obtained from 60 systemically healthy non-smoker individuals with periodontitis (P, n=20), gingivitis(G, n=20) and healthy periodontium (S, n=20).
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hazal Akkaya, Izmir Katip Celebi University
- Investigators
- Mehmet Sağlam, Study director, Izmir Katip Çelebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777487
- Sponsor's protocol ID
- 2019-TDU-DİŞF-0008
- Status last verified
- Mar 2021
- First submitted
- 27 Feb 2021
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Peptidyl Arginine Deiminase 4 (PAD4), Galectin-3 and TNF-α Levels in Gingival Crevicular Fluid of Patients With Different Periodontal Diseases
- ClinicalTrials.gov ID
- NCT04777487
- Acronym / sponsor ID
- 2019-TDU-DİŞF-0008
- Conditions
- Periodontal Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 25 Sep 2019 (actual)
- Study completion
- 25 Sep 2019 (actual)
- First posted
- 2 Mar 2021 (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.
Objectives: The aim of this study is; detection of peptidyl arginine deiminase4 (PAD4), galectin-3 and tumor necrosis factor alpha (TNF-α) levels in gingival crevicular fluid (GCF) samples of periodontally healthy, gingivitis and periodontitis patients and the possible correlation between these values and clinical parameters of periodontal diseases. Materials and methods: Samples of GCF were obtained from 60systemically healthy non-smoker individuals with periodontitis (P, n=20), gingivitis(G, n=20) and healthy periodontium (S, n=20). Full-mouth clinical periodontal measurements including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), gingival index (GI) and plaque index (PI) were also recorded. Enzyme-linked immunosorbent assay (ELISA) was used to determine PAD4, galectin-3 and TNF-α levels in the biological samples.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- According to full-mouth clinical periodontal measurements including probing depth (PD), clinical attachment level (CAL),bleeding on probing (BOP), gingival index (GI) and plaque index (PI) samples of GCF were obtained from 60 systemically healthy non-smoker individuals with periodontitis (P, n=20), gingivitis(G, n=20) and healthy periodontium (S, n=20).
| Arm | Type | Receives |
|---|---|---|
| Healthy Periodontium | Experimental | Diagnostic Test: GCF obtainingFull-mouth clinical periodontal measurements recorded and GCF obtained. |
| Gingivitis | Experimental | Diagnostic Test: GCF obtainingFull-mouth clinical periodontal measurements recorded and GCF obtained. |
| Periodontitis | Experimental | Diagnostic Test: GCF obtainingFull-mouth clinical periodontal measurements recorded and GCF obtained. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Systemically healthy (The determination of healthy volunteers will be based on the statements of the patients in the anamnesis. No additional examinations will be made.)
- At least twenty permanent teeth in the mouth
- Non-smoker
- No medication for continuous use
- Those who have not used antibiotics, anti-inflammatory and systemic corticosteroid drugs in the last 6 months.
Key exclusion criteria (6 listed)
- Any oral or systemic disease
- Regularly using a systemic medication
- During pregnancy or lactation
- Received periodontal treatment within the last 6 months.
- Those who received antibiotic, anti-inflammatory or systemic corticosteroid medication in the last 6 months
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 |
|---|---|---|
| GCF obtaining4 samples of gingival crevicular fluid, 1 from each quadrant of the patient's jaw, were collected by means of paper strips. | Diagnostic test | Gingivitis, Healthy Periodontium, Periodontitis |
Primary outcome
The total amount of Galectin-3 in GCF
Time frame: 24 hours after taking the clinical measurements at the first visit
The total amount of Galectin-3 in GCF
The total amount of PAD4 in GCF
Time frame: 24 hours after taking the clinical measurements at the first visit
The total amount of PAD4 in GCF
1 secondary outcome
The total amount of TNF-α in GCF
Time frame: 24 hours after taking the clinical measurements at the first visit
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 2 Mar 2021.
- Individual participant dataSharing planned: Yes
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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.
Mehmet Sağlam study director
Izmir Katip Çelebi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GCF obtaining in people with Periodontal Diseases, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
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 10 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 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The total amount of Galectin-3 in GCF (time frame: 24 hours after taking the clinical measurements at the first visit). The study lists 2 primary outcomes in all. 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 2 Mar 2021.