Periodontal DiseasesNCT06561802
Evaluation of GCF And Salivary Ferritin, ALP And MMP-8 Levels of Individuals With Different Periodontal Diseases
A study testing GCF and saliva obtaining in people with Periodontal Diseases, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this clinical study was to determine the levels of ferritin, alkaline phosphatase and matrix metalloproteinase-8 in the gingival crevicular fluid (GCF) and saliva samples were collected from 60 systemically healthy, non-smoker periodontitis (P group, n = 20), gingivitis (G group, n = 20) and periodontally… 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 and saliva obtaining
- Type of treatment
- Injection or infusion
- 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 30 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
- 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, Çiğli, 35640
About this study
Official title: Evaluation Of Gingival Crevicular Fluid And Salivary Ferritin, Alkaline Phosphatase And Matrix Metalloproteinase-8 Levels Of Individuals With Different Periodontal Diseases
The aim of this clinical study was to determine the levels of ferritin, alkaline phosphatase and matrix metalloproteinase-8 in the gingival crevicular fluid (GCF) and saliva samples were collected from 60 systemically healthy, non-smoker periodontitis (P group, n = 20), gingivitis (G group, n = 20) and periodontally healthy individuals (S group, n = 20) and all clinical parameters were recorded for all groups at baseline. GCF and serum samplings and clinical records were also repeated at 1st and 3rd months visitsfor only P group. Ferritin, MMP8, and ALP levels in samples were determined by enzyme-linked immunosorbent assay (ELISA).
- Conditions
- Periodontal Diseases
- Being tested
- GCF and saliva 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 and saliva obtainingDiagnostic test
The patient was asked to sit upright and tilt his/her head forward to collect saliva samples. İn this way, unstimulated saliva was allowed to accumulate in the floor of the mouth. The accumulated saliva was collected in a sterile container. It was then transferred to a propylene tube. The tubes were centrifuged and the clear part at the top of the tube was taken with a sterile syringe and transferred to a different propylene tube with 0.5 ml in each tube. Also, 4 samples of gingival crevicular fluid, 1 from each quadrant of the patient's jaw, were collected by means of paper strips and put into propylene tube. Tubes were stored at -80ºC until the day of analysis.
| Study group | Role | What they receive |
|---|---|---|
| periodontally healthy | Experimental | Full-mouth clinical periodontal measurements recorded and GCF and saliva obtained. Receives: Diagnostic Test: GCF and saliva obtaining |
| gingivitis | Experimental | Full-mouth clinical periodontal measurements recorded and GCF and saliva obtained. Receives: Diagnostic Test: GCF and saliva obtaining |
| periodontitis | Experimental | Full-mouth clinical periodontal measurements recorded and GCF and saliva obtained. Receives: Diagnostic Test: GCF and saliva obtaining |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total amount of Ferritin in GCF and saliva
Measured: 24 hours after taking the clinical measurements at the first visit
The total amount of ALP in GCF and saliva
Measured: 24 hours after taking the clinical measurements at the first visit
Secondary outcomes (1)
The total amount of MMP-8 in GCF and saliva
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 posted20 Aug 2024
- Study start1 Apr 2019
- Primary completion17 Sep 2019
- Study completion30 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
- 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, Erim Bozkurt, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561802
- Sponsor's protocol ID
- 2019-TDR-SABE-0009
- Status last verified
- Aug 2024
- First submitted
- 16 Aug 2024
- Last updated
- 21 Aug 2024
- 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 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Gingival Crevicular Fluid And Salivary Ferritin, Alkaline Phosphatase And Matrix Metalloproteinase-8 Levels Of Individuals With Different Periodontal Diseases
- ClinicalTrials.gov ID
- NCT06561802
- Acronym / sponsor ID
- 2019-TDR-SABE-0009
- 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
- 17 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 20 Aug 2024 (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 clinical study was to determine the levels of ferritin, alkaline phosphatase and matrix metalloproteinase-8 in the gingival crevicular fluid (GCF) and saliva samples were collected from 60 systemically healthy, non-smoker periodontitis (P group, n = 20), gingivitis (G group, n = 20) and periodontally healthy individuals (S group, n = 20) and all clinical parameters were recorded for all groups at baseline. GCF and serum samplings and clinical records were also repeated at 1st and 3rd months visitsfor only P group. Ferritin, MMP8, and ALP levels in samples were determined by enzyme-linked immunosorbent assay (ELISA).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| periodontally healthy | Experimental | Diagnostic Test: GCF and saliva obtainingFull-mouth clinical periodontal measurements recorded and GCF and saliva obtained. |
| gingivitis | Experimental | Diagnostic Test: GCF and saliva obtainingFull-mouth clinical periodontal measurements recorded and GCF and saliva obtained. |
| periodontitis | Experimental | Diagnostic Test: GCF and saliva obtainingFull-mouth clinical periodontal measurements recorded and GCF and saliva obtained. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Systemically healthy
- 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 and saliva obtainingThe patient was asked to sit upright and tilt his/her head forward to collect saliva samples. İn this way, unstimulated saliva was allowed to accumulate in the floor of the mouth. The accumulated saliva was collected in a sterile container. It was then transferred to a propylene tube. The tubes were centrifuged and the clear part at the top of the tube was taken with a sterile syringe and transferred to a different propylene tube with 0.5 ml in each tube. Also, 4 samples of gingival crevicular fluid, 1 from each quadrant of the patient's jaw, were collected by means of paper strips and put into propylene tube. Tubes were stored at -80ºC until the day of analysis. | Diagnostic test | gingivitis, periodontally healthy, periodontitis |
Primary outcome
The total amount of Ferritin in GCF and saliva
Time frame: 24 hours after taking the clinical measurements at the first visit
The total amount of ALP in GCF and saliva
Time frame: 24 hours after taking the clinical measurements at the first visit
1 secondary outcome
The total amount of MMP-8 in GCF and saliva
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 21 Aug 2024.
- Individual participant dataSharing planned: Yes
Related trials for Periodontal Diseases
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
Thermosensitive Hyaluronic Gel With Octenidine as an Adjunctive to Subgingival Instrumentation
Periodontal Disease
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
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 and saliva 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 21 Aug 2024. 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 Ferritin in GCF and saliva (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 21 Aug 2024.