PeriodontitisNCT06850987
Effect of Nonsurgical Periodontal Treatment on Apelin and Oxidative Stress Levels
An observational study of Periodontitis, run by Hatice Yemenoğlu at 1 site in Turkey (Türkiye).
Trial summary
Periodontitis is a multifactorial, chronic inflammatory disease triggered by microorganisms in the dental biofilm. The limited data of clinical periodontal measurements in the diagnosis of periodontitis have led to the search for more reliable biomarkers that can be used in the diagnosis and follow-up of periodontal… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- non surgical periodontal therapy, measurement of periodontal clinical parameters and Gingival crevicular fluid samples will be collected
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Aug 2024to 14 Jun 2025
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: periodontitis
Who may be able to join
- Being systemically healthy
- Not smoking
- Not using anti-inflammatory drugs in the last 3 months, antibiotics and systemic corticosteroids in the last 6 months
- Not being pregnant or lactating
- Not having received periodontal treatment in the last 6 months
- Having at least 20 teeth in the mouth
- Being diagnosed with periodontitis (Stage 1-2 and Stage 3-4) by the researcher
- Working groups will be formed based on the 2017 Periodontal Disease Classification
Who cannot join
- being periodontally healthy having systemic disease being pregnant and lactating smoking having periodontal treatment in the last 6 months having fewer than 20 teeth
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Recep Tayyip Erdoğan University Faculty of Dentistry
Rize, Turkey, 53020
About this study
Official title: Evaluation of the Effects of Nonsurgical Periodontal Treatment on Apelin and Oxidative Stress Levels in Individuals With Periodontitis
Periodontitis is a multifactorial, chronic inflammatory disease triggered by microorganisms in the dental biofilm. The limited data of clinical periodontal measurements in the diagnosis of periodontitis have led to the search for more reliable biomarkers that can be used in the diagnosis and follow-up of periodontal diseases. Apelin is another adipokine that has been investigated in a small number of studies so far; its receptor (apelin reseptor (APJ)) was first identified in 1993 and later isolated as a molecule in 1998. Studies have focused on this form of apelin-13 due to its high biological activity. Although apelin-13 is considered the most biologically active form, it has been shown that apelin-36 has a much higher binding affinity to APJ than apelin-13. Periodontitis is the most common cause of tooth loss in adults, and is associated with systemic conditions such as metabolic syndrome, diabetes mellitus, and cardiovascular disease. The elucidation of these possible interactions has been the focus of many studies. Apelin is associated with insulin secretion, as well as its effects on lipid and glucose metabolism. Studies in both humans and animals have shown that type 2 diabetes and obesity are typically associated with increased plasma apelin levels. Based on this observation, recent studies have shown that salivary and serum apelin levels are higher in individuals with chronic periodontitis and type 2 diabetes compared to healthy individuals. Considering all this information, the investigators considered that apelin may be a biomarker for periodontal diseases due to its inflammation-regulating effects as a result of the change in gingival crevicular fluid (GCF) apelin-13, apelin-36 and total oxidant status (TOS)/total antioxidant status (TAS) levels compared to the initial level after non-surgical periodontal treatment in systemically healthy and periodontitis individuals, considering the relationship of adipokines with periodontal disease in this study.
- Conditions
- Periodontitis
- Being tested
- non surgical periodontal therapy, measurement of periodontal clinical parameters, Gingival crevicular fluid samples will be collected
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non surgical periodontal therapyProcedure or surgery
All participants will have their non-surgical periodontal treatments completed after samples are taken and periodontal measurements are taken at the beginning.
measurement of periodontal clinical parametersOther
Periodontal measurements will be taken from all participants at baseline, 1 month, 3 months and 6 months
Gingival crevicular fluid samples will be collectedOther
Gingival crevicular fluid samples will be collected from all participants at baseline, 1 month, 3 months and 6 months
| Study group | Role | What they receive |
|---|---|---|
| Stage 1-2 periodontitis group | Not described Receives: Procedure: non surgical periodontal therapy; Other: measurement of periodontal clinical parameters; Other: Gingival crevicular fluid samples will be collected | |
| Stage 3-4 periodontitis group | Not described Receives: Procedure: non surgical periodontal therapy; Other: measurement of periodontal clinical parameters; Other: Gingival crevicular fluid samples will be collected |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal pocket depth
It will be calculated by measuring the distance between the gingival margin and the pocket base. Each tooth will be measured from six surfaces and averaged. higher scores indicate worse outcome.
Measured: at baseline, 1 month, 3 months and 6 months
clinical attachment loss
It will be calculated by measuring the distance between the cementoenamel border and the pocket base. It will be measured from the six surfaces of each tooth and the average will be taken. higher scores indicate worse outcome.
Measured: at baseline, 1 month, 3 months and 6 months
Secondary outcomes (4)
Apelin-13 level
Determination of the levels of apelin-13 from gingival crevicular fluid (GCF) samples will be done by ELISA method
Measured: at the beginning, at 1 month, at 3 months and at 6 months
Apelin-36 level
Determination of the levels of apelin-36 from gingival crevicular fluid (GCF) samples will be done by ELISA method
Measured: at baseline, 1 month, 3 months and 6 months
TOS (total oxidant status) level
Determination of the levels of TOS (total oxidant status) from gingival crevicular fluid (GCF) samples will be done by ELISA method
Measured: at baseline, 1 month, 3 months and 6 months
TAS (total antioxidant status) level
Determination of the levels of TAS (total antioxidant status) from gingival crevicular fluid (GCF) samples will be done by ELISA method
Measured: at baseline, 1 month, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start16 Aug 2024
- Primary completion14 May 2025
- Study completion14 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hatice Yemenoğlu
- Sponsor type
- University, hospital or other
- Collaborators
- Recep Tayyip Erdogan University Training and Research Hospital
- Responsible party
- Sponsor-investigator, Hatice Yemenoğlu, Recep Tayyip Erdogan University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850987
- Sponsor's protocol ID
- Recep TayyipErdoganUniversity
- Status last verified
- Jul 2025
- First submitted
- 16 Feb 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If deemed necessary, necessary information can be provided to protect patient confidentiality.
Publications
Aydogan GN, Yemenoglu H, Kose O, Bostan SA, Mataraci Karakas S, Yilmaz A. Effects of Non-Surgical Periodontal Therapy on Gingival Crevicular Fluid Apelin Isoforms and Oxidative Stress Markers in Periodontitis. Diagnostics (Basel). 2026 Aug 6;16(15):2484. doi: 10.3390/diagnostics16152484.
PubMed 42587720
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Nonsurgical Periodontal Treatment on Apelin and Oxidative Stress Levels in Individuals With Periodontitis
- ClinicalTrials.gov ID
- NCT06850987
- Acronym / sponsor ID
- Recep TayyipErdoganUniversity
- Conditions
- Periodontitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hatice YemenoğluUniversity, hospital or other
- Collaborators
- Recep Tayyip Erdogan University Training and Research Hospital
- Study start
- 16 Aug 2024 (actual)
- Primary completion
- 14 May 2025 (actual)
- Study completion
- 14 Jun 2025 (actual)
- First posted
- 28 Feb 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.
Periodontitis is a multifactorial, chronic inflammatory disease triggered by microorganisms in the dental biofilm. The limited data of clinical periodontal measurements in the diagnosis of periodontitis have led to the search for more reliable biomarkers that can be used in the diagnosis and follow-up of periodontal diseases. Apelin is another adipokine that has been investigated in a small number of studies so far; its receptor (apelin reseptor (APJ)) was first identified in 1993 and later isolated as a molecule in 1998. Studies have focused on this form of apelin-13 due to its high biological activity. Although apelin-13 is considered the most biologically active form, it has been shown that apelin-36 has a much higher binding affinity to APJ than apelin-13. Periodontitis is the most common cause of tooth loss in adults, and is associated with systemic conditions such as metabolic syndrome, diabetes mellitus, and cardiovascular disease. The elucidation of these possible interactions has been the focus of many studies. Apelin is associated with insulin secretion, as well as its effects on lipid and glucose metabolism. Studies in both humans and animals have shown that type 2 diabetes and obesity are typically associated with increased plasma apelin levels. Based on this observation, recent studies have shown that salivary and serum apelin levels are higher in individuals with chronic periodontitis and type 2 diabetes compared to healthy individuals. Considering all this information, the investigators considered that apelin may be a biomarker for periodontal diseases due to its inflammation-regulating effects as a result of the change in gingival crevicular fluid (GCF) apelin-13, apelin-36 and total oxidant status (TOS)/total antioxidant status (TAS) levels compared to the initial level after non-surgical periodontal treatment in systemically healthy and periodontitis individuals, considering the relationship of adipokines with periodontal disease in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stage 1-2 periodontitis group | – | Procedure: non surgical periodontal therapy, Other: measurement of periodontal clinical parameters, Other: Gingival crevicular fluid samples will be collected |
| Stage 3-4 periodontitis group | – | Procedure: non surgical periodontal therapy, Other: measurement of periodontal clinical parameters, Other: Gingival crevicular fluid samples will be collected |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- periodontitis
Key inclusion criteria (8 listed)
- Being systemically healthy
- Not smoking
- Not using anti-inflammatory drugs in the last 3 months, antibiotics and systemic corticosteroids in the last 6 months
- Not being pregnant or lactating
- Not having received periodontal treatment in the last 6 months
Key exclusion criteria (1 listed)
- being periodontally healthy having systemic disease being pregnant and lactating smoking having periodontal treatment in the last 6 months having fewer than 20 teeth
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 |
|---|---|---|
| non surgical periodontal therapyAll participants will have their non-surgical periodontal treatments completed after samples are taken and periodontal measurements are taken at the beginning. | Procedure or surgery | Stage 1-2 periodontitis group, Stage 3-4 periodontitis group |
| measurement of periodontal clinical parametersPeriodontal measurements will be taken from all participants at baseline, 1 month, 3 months and 6 months | Other | Stage 1-2 periodontitis group, Stage 3-4 periodontitis group |
| Gingival crevicular fluid samples will be collectedGingival crevicular fluid samples will be collected from all participants at baseline, 1 month, 3 months and 6 months | Other | Stage 1-2 periodontitis group, Stage 3-4 periodontitis group |
Primary outcome
Periodontal pocket depth
Time frame: at baseline, 1 month, 3 months and 6 months
It will be calculated by measuring the distance between the gingival margin and the pocket base. Each tooth will be measured from six surfaces and averaged. higher scores indicate worse outcome.
clinical attachment loss
Time frame: at baseline, 1 month, 3 months and 6 months
It will be calculated by measuring the distance between the cementoenamel border and the pocket base. It will be measured from the six surfaces of each tooth and the average will be taken. higher scores indicate worse outcome.
4 secondary outcomes
Apelin-13 level
Time frame: at the beginning, at 1 month, at 3 months and at 6 months
Apelin-36 level
Time frame: at baseline, 1 month, 3 months and 6 months
TOS (total oxidant status) level
Time frame: at baseline, 1 month, 3 months and 6 months
TAS (total antioxidant status) level
Time frame: at baseline, 1 month, 3 months and 6 months
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 30 Jul 2025.
- Derived from this study: PubMed 42587720Aydogan GN, Yemenoglu H, Kose O, Bostan SA, Mataraci Karakas S, Yilmaz A. Effects of Non-Surgical Periodontal Therapy on Gingival Crevicular Fluid Apelin Isoforms and Oxidative Stress Markers in Periodontitis. Diagnostics (Basel). 2026 Aug 6;16(15):2484. doi: 10.3390/diagnostics16152484.
- Individual participant dataSharing planned: Yes. If deemed necessary, necessary information can be provided to protect patient confidentiality.
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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, run by Hatice Yemenoğlu 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 8 inclusion and 1 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 30 Jul 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?
Periodontal pocket depth (time frame: at baseline, 1 month, 3 months and 6 months). 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?
On the ClinicalTrials.gov record for NCT06850987, which also lists 1 linked publication.
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 30 Jul 2025.