Mouth DiseasesNCT05435131
Evaluation of Biomarkers Levels in Gingival Crevicular Fluid, Saliva and Serum for Different Periodontal Diseases
A study testing GCF obtaining, Saliva Obtaining and Serum obtaining in people with Mouth Diseases and Periodontal Inflammation, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is; detection of interleukin(IL)-38, IL-36 gamma(γ) , IL-17 and matrix metalloproteinase(MMP)-9 levels in gingival crevicular fluid (GCF), saliva and serum 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 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mouth Diseases, Periodontal Inflammation, Periodontal Diseases
- What is being tested?
- GCF obtaining, Saliva Obtaining and Serum obtaining
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 11 Jan 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older 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.
- For the periodontitis group that has not received periodontal treatment in the last 6 months
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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Akdeniz University Faculty of Dentistry
Antalya, 07070
About this study
Official title: Evaluation of Interleukin (IL)-38, IL-36-gamma, IL-17 and Matrix Metalloproteinase-9 Levels in Gingival Crevicular Fluid, Saliva and Serum for Periodontal Health, Gingivitis and Periodontitis
The aim of this study is; detection of interleukin(IL)-38, IL-36 gamma(γ) , IL-17 and matrix metalloproteinase(MMP)-9 levels in gingival crevicular fluid (GCF), saliva and serum 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 were obtained from 90 systemically healthy non-smoker individuals with periodontitis (P, n=30), gingivitis(G, n=30) and healthy periodontium (S, n=30). 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 IL-38, IL-36γ, IL-17 and MMP-9 levels in the biological samples.
- Being tested
- GCF obtaining, Saliva Obtaining, Serum obtaining
- Medical subject headings
- Mouth Diseases, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GCF obtainingDiagnostic test
GCF obtaining: 2 GCF samples, 1 from the interproximal surface of 2 different teeth that bleeding on probing(-), were taken from each participant
Saliva ObtainingDiagnostic test
Saliva obtaining: 1,5 ml unstimulated whole saliva collected from each participant
Serum obtainingDiagnostic test
Serum obtaining : 8 ml of venous blood was collected from each participant and collecting blood centrifuged to obtain serum
| Study group | Role | What they receive |
|---|---|---|
| Periodontal Health | Experimental | Full-mouth clinical periodontal measurements recorded and GCF, saliva serum obtained. Receives: Diagnostic Test: GCF obtaining; Diagnostic Test: Saliva Obtaining; Diagnostic Test: Serum obtaining |
| Gingivitis | Experimental | Full-mouth clinical periodontal measurements recorded and GCF, saliva serum obtained. Receives: Diagnostic Test: GCF obtaining; Diagnostic Test: Saliva Obtaining; Diagnostic Test: Serum obtaining |
| Stage II grade B Periodontitis | Experimental | Full-mouth clinical periodontal measurements recorded and GCF, saliva serum obtained. Receives: Diagnostic Test: GCF obtaining; Diagnostic Test: Saliva Obtaining; Diagnostic Test: Serum obtaining |
| Stage III grade B Periodontitis | Experimental | Full-mouth clinical periodontal measurements recorded and GCF, saliva serum obtained. Receives: Diagnostic Test: GCF obtaining; Diagnostic Test: Saliva Obtaining; Diagnostic Test: Serum obtaining |
| Stage III grade C Periodontitis | Experimental | Full-mouth clinical periodontal measurements recorded and GCF, saliva serum obtained. Receives: Diagnostic Test: GCF obtaining; Diagnostic Test: Saliva Obtaining; Diagnostic Test: Serum obtaining |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of Interleukin-38 (pg/ml) in GCF, saliva and serum fluid
Measured: 24 hours after taking the clinical measurements at the first visit
Levels of Interleukin-36 gamma (pg/ml) in GCF, saliva and serum fluid
Measured: 24 hours after taking the clinical measurements at the first visit
Secondary outcomes (2)
Levels of Interleukin-17 (pg/ml) in GCF, saliva and serum fluid
Measured: 24 hours after taking the clinical measurements at the first visit
Levels of Matrix Metalloproteinase-9 (ng/ml) in GCF, saliva and serum fluid
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 posted28 Jun 2022
- Study start1 Jun 2020
- Primary completion11 Jan 2021
- Study completion11 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mouth DiseasesStudies of the same condition, open and under way.
- More trials run by Akdeniz 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
- 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, saliva and serum were obtained from 90 systemically healthy non-smoker individuals with stage II grade B (P1, n=9), stage III grade B (P2, n=11) , stage III grade C (n=10), gingivitis (G, n=30) and healthy periodontium (S, n=30).
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilal Korkmaz, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435131
- Sponsor's protocol ID
- Hkorkmaz
- Status last verified
- Jun 2022
- First submitted
- 22 Jun 2022
- Last updated
- 1 Jul 2022
- 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 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Interleukin (IL)-38, IL-36-gamma, IL-17 and Matrix Metalloproteinase-9 Levels in Gingival Crevicular Fluid, Saliva and Serum for Periodontal Health, Gingivitis and Periodontitis
- ClinicalTrials.gov ID
- NCT05435131
- Acronym / sponsor ID
- Hkorkmaz
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 11 Jan 2021 (actual)
- Study completion
- 11 Jan 2021 (actual)
- First posted
- 28 Jun 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 aim of this study is; detection of interleukin(IL)-38, IL-36 gamma(γ) , IL-17 and matrix metalloproteinase(MMP)-9 levels in gingival crevicular fluid (GCF), saliva and serum 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 were obtained from 90 systemically healthy non-smoker individuals with periodontitis (P, n=30), gingivitis(G, n=30) and healthy periodontium (S, n=30). 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 IL-38, IL-36γ, IL-17 and MMP-9 levels in the biological samples.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- 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, saliva and serum were obtained from 90 systemically healthy non-smoker individuals with stage II grade B (P1, n=9), stage III grade B (P2, n=11) , stage III grade C (n=10), gingivitis (G, n=30) and healthy periodontium (S, n=30).
| Arm | Type | Receives |
|---|---|---|
| Periodontal Health | Experimental | Diagnostic Test: GCF obtaining, Diagnostic Test: Saliva Obtaining, Diagnostic Test: Serum obtainingFull-mouth clinical periodontal measurements recorded and GCF, saliva serum obtained. |
| Gingivitis | Experimental | Diagnostic Test: GCF obtaining, Diagnostic Test: Saliva Obtaining, Diagnostic Test: Serum obtainingFull-mouth clinical periodontal measurements recorded and GCF, saliva serum obtained. |
| Stage II grade B Periodontitis | Experimental | Diagnostic Test: GCF obtaining, Diagnostic Test: Saliva Obtaining, Diagnostic Test: Serum obtainingFull-mouth clinical periodontal measurements recorded and GCF, saliva serum obtained. |
| Stage III grade B Periodontitis | Experimental | Diagnostic Test: GCF obtaining, Diagnostic Test: Saliva Obtaining, Diagnostic Test: Serum obtainingFull-mouth clinical periodontal measurements recorded and GCF, saliva serum obtained. |
| Stage III grade C Periodontitis | Experimental | Diagnostic Test: GCF obtaining, Diagnostic Test: Saliva Obtaining, Diagnostic Test: Serum obtainingFull-mouth clinical periodontal measurements recorded and GCF, saliva serum obtained. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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 obtainingGCF obtaining: 2 GCF samples, 1 from the interproximal surface of 2 different teeth that bleeding on probing(-), were taken from each participant | Diagnostic test | Gingivitis, Periodontal Health, Stage II grade B Periodontitis, Stage III grade B Periodontitis, Stage III grade C Periodontitis |
| Saliva ObtainingSaliva obtaining: 1,5 ml unstimulated whole saliva collected from each participant | Diagnostic test | Gingivitis, Periodontal Health, Stage II grade B Periodontitis, Stage III grade B Periodontitis, Stage III grade C Periodontitis |
| Serum obtainingSerum obtaining : 8 ml of venous blood was collected from each participant and collecting blood centrifuged to obtain serum | Diagnostic test | Gingivitis, Periodontal Health, Stage II grade B Periodontitis, Stage III grade B Periodontitis, Stage III grade C Periodontitis |
Primary outcome
Levels of Interleukin-38 (pg/ml) in GCF, saliva and serum fluid
Time frame: 24 hours after taking the clinical measurements at the first visit
Levels of Interleukin-36 gamma (pg/ml) in GCF, saliva and serum fluid
Time frame: 24 hours after taking the clinical measurements at the first visit
2 secondary outcomes
Levels of Interleukin-17 (pg/ml) in GCF, saliva and serum fluid
Time frame: 24 hours after taking the clinical measurements at the first visit
Levels of Matrix Metalloproteinase-9 (ng/ml) in GCF, saliva and serum fluid
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 1 Jul 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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, Saliva Obtaining and Serum obtaining in people with Mouth Diseases and Periodontal Inflammation, run by Akdeniz 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 7 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 1 Jul 2022. 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?
Levels of Interleukin-38 (pg/ml) in GCF, saliva and serum fluid (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 1 Jul 2022.