PeriodontitisNCT07201142
Gingival Crevicular Fluid and Salivary Levels of GDF-15, Smad2, Smad5, Smad6, and IL-6 in Patients With Periodontitis
An observational study of Periodontitis and Periodontal Disease, run by Melis Yilmaz at 1 site in Turkey (Türkiye).
Trial summary
The dysregulation of the transforming growth factor-beta signaling pathway can lead to inflammation and tissue destruction in the pathogenesis of periodontitis. This study aims to evaluate the levels of GDF-15, Smad 2, Smad 5, Smad 6, and IL-6 in gingival crevicular fluid (GCF) and saliva between individuals with… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Periodontal Disease
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Apr 2023to 17 Dec 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population comprised individuals who presented to the Department of Periodontology at Istanbul Medipol University between April and October 2023 for dental consultation or treatment.
Who may be able to join
- being over 18 years of age;
- having at least 20 natural teeth excluding third molars;
- being systemically healthy
Who cannot join
- under 18 years of age;
- had used antibiotics
- had used nonsteroidal anti-inflammatory drugs, corticosteroids, immunosuppressants, beta-blockers, calcium channel blockers, anticoagulants, or hormonal contraceptives within the past 6 months;
- had systemic diseases such as diabetes mellitus, rheumatoid arthritis, cardiovascular diseases, epilepsy, renal or hepatic disorders, or viral infections like HIV/AIDS;
- pregnant or breastfeeding;
- current smokers or had a history of alcoholism;
Show all 9Show fewer
- had received nonsurgical periodontal therapy within the last 6 months or surgical periodontal treatment within the last 12 months;
- had fewer than 20 natural teeth (excluding third molars);
- had fixed orthodontic appliances.
Trial locations and contacts
1 site in 1 country.
About this study
The dysregulation of the transforming growth factor-beta signaling pathway can lead to inflammation and tissue destruction in the pathogenesis of periodontitis. This study aims to evaluate the levels of GDF-15, Smad 2, Smad 5, Smad 6, and IL-6 in gingival crevicular fluid (GCF) and saliva between individuals with periodontitis and periodontal healthy controls and to evaluate the relationship of these biomarkers with clinical periodontal parameters. This study aims to investigate the levels of GDF-15, Smad2, Smad5, Smad6, and IL-6 in GCF and saliva samples from individuals with periodontitis and periodontally healthy controls, as well as to assess the associations of these biomarkers with clinical periodontal parameters. A total of 44 systemically healthy individuals, including 22 patients diagnosed with stage III/grade B periodontitis and 22 periodontal healthy individuals, were included in the study. Clinical periodontal parameters (plaque index (PI), probing depth (PD), clinical attachment level (CAL), and bleeding on probing (BOP)) were recorded. GDF-15, Smad 2, Smad 5, Smad 6, and IL-6 levels in saliva and GCF were analyzed using the ELISA method.
- Conditions
- Periodontitis, Periodontal Disease
- Medical subject headings
- Periodontitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Periodontitis | Not described | |
| Control | Periodontally Healthy |
What is being measured
The primary outcome is the main question the study is designed to answer.
GCF GDF-15, GCF IL-6, GCF SMAD 2, GCF Smad 5, GCF Smad 6
Measured: September 2023 to February 2024
Saliva GDF-15, Saliva IL-6, Saliva SMAD 2, Saliva Smad 5, Saliva Smad 6,
Measured: September 2023 to Februart-y 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start3 Apr 2023
- Primary completion14 Nov 2024
- Study completion17 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melis Yilmaz
- Sponsor type
- University, hospital or other
- Collaborators
- Medipol University
- Responsible party
- Sponsor-investigator, Melis Yilmaz, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201142
- Sponsor's protocol ID
- 1097/22.12.2022
- Status last verified
- May 2025
- First submitted
- 30 May 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gingival Crevicular Fluid and Salivary Levels of GDF-15, Smad2, Smad5, Smad6, and IL-6 in Patients With Periodontitis
- ClinicalTrials.gov ID
- NCT07201142
- Acronym / sponsor ID
- 1097/22.12.2022
- Conditions
- Periodontitis, Periodontal Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Melis YilmazUniversity, hospital or other
- Collaborators
- Medipol University
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 14 Nov 2024 (actual)
- Study completion
- 17 Dec 2024 (actual)
- First posted
- 1 Oct 2025 (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 dysregulation of the transforming growth factor-beta signaling pathway can lead to inflammation and tissue destruction in the pathogenesis of periodontitis. This study aims to evaluate the levels of GDF-15, Smad 2, Smad 5, Smad 6, and IL-6 in gingival crevicular fluid (GCF) and saliva between individuals with periodontitis and periodontal healthy controls and to evaluate the relationship of these biomarkers with clinical periodontal parameters. This study aims to investigate the levels of GDF-15, Smad2, Smad5, Smad6, and IL-6 in GCF and saliva samples from individuals with periodontitis and periodontally healthy controls, as well as to assess the associations of these biomarkers with clinical periodontal parameters. A total of 44 systemically healthy individuals, including 22 patients diagnosed with stage III/grade B periodontitis and 22 periodontal healthy individuals, were included in the study. Clinical periodontal parameters (plaque index (PI), probing depth (PD), clinical attachment level (CAL), and bleeding on probing (BOP)) were recorded. GDF-15, Smad 2, Smad 5, Smad 6, and IL-6 levels in saliva and GCF were analyzed using the ELISA method.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periodontitis | – | – |
| Control | – | –Periodontally Healthy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprised individuals who presented to the Department of Periodontology at Istanbul Medipol University between April and October 2023 for dental consultation or treatment.
Key inclusion criteria (3 listed)
- being over 18 years of age;
- having at least 20 natural teeth excluding third molars;
- being systemically healthy
Key exclusion criteria (9 listed)
- under 18 years of age;
- had used antibiotics
- had used nonsteroidal anti-inflammatory drugs, corticosteroids, immunosuppressants, beta-blockers, calcium channel blockers, anticoagulants, or hormonal contraceptives within the past 6 months;
- had systemic diseases such as diabetes mellitus, rheumatoid arthritis, cardiovascular diseases, epilepsy, renal or hepatic disorders, or viral infections like HIV/AIDS;
- pregnant or breastfeeding;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
GCF GDF-15, GCF IL-6, GCF SMAD 2, GCF Smad 5, GCF Smad 6
Time frame: September 2023 to February 2024
Saliva GDF-15, Saliva IL-6, Saliva SMAD 2, Saliva Smad 5, Saliva Smad 6,
Time frame: September 2023 to Februart-y 2024
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 Oct 2025.
- Individual participant dataSharing planned: No
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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?
An observational study of Periodontitis and Periodontal Disease, run by Melis Yilmaz 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 3 inclusion and 9 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 Oct 2025. 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?
GCF GDF-15, GCF IL-6, GCF SMAD 2, GCF Smad 5, GCF Smad 6 (time frame: September 2023 to February 2024). 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 Oct 2025.