Assessment of Salivary Biomarker Levels in Individuals With Various Periodontal Diseases

An observational study of Periodontal Diseases, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The aim of this study is to compare the salivary levels of HIF-2 alpha, MMP-9, and TRAP-5b among healthy individuals, patients with gingivitis, and patients with periodontitis; to examine the relationship between these levels and clinical parameters; and to determine their effectiveness in distinguishing periodontal… Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Periodontal Diseases
What is being tested?: saliva obtaining
Type of treatment: Injection or infusion
How many people: 60 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 10 Jul 2025to 1 Apr 2026
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
Healthy volunteers accepted
Adult, Older adult

Study population: Systemically healthy, nonsmoking adults were recruited from individuals attending the Department of Periodontology, Faculty of Dentistry, İzmir Katip Çelebi University. Participants were classified into periodontal health, gingivitis, and periodontitis groups according to the 2017 Classification of Periodontal and Peri-implant Diseases and Conditions. Each group included 20 participants, for a total sample of 60 individuals.

Who may be able to join

Systemically healthy (The identification of healthy volunteers will be based on patients' self-reported medical history; no additional diagnostic tests will be conducted.)
Having at least twenty permanent teeth in the mouth
Non-smoker
Not on any continuous medication
No use of antibiotics, anti-inflammatory drugs, or systemic corticosteroids in the last 6 months
Not pregnant or lactating

Show all 9Show fewer

No periodontal treatment within the last 6 months
Willing to participate in the study and having signed the "Informed Consent Form"
Between 18 and 65 years of age

Who cannot join

Having any oral or systemic disease
Being on regular systemic medication
Being pregnant or in the lactation period
Having received periodontal treatment within the last 6 months
Having used antibiotics, anti-inflammatory drugs, or systemic corticosteroids in the last 6 months
Smoking
Being under 18 years of age

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Izmir Katip Celebi University Faculty of Dentistry
Izmir, Cigli, 35640

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of Salivary Hypoxia-Inducible Factor -2 Alpha, Matrix Metalloproteinase-9 and Tartrate-Resistant Acid Phosphatase-5b Levels in Individuals With Different Periodontal Diseases

Periodontal health is defined as the absence of signs of inflammation. Gingivitis is an inflammation of the gums and, if left untreated, can progress to periodontitis, a more severe condition characterized by the destruction of the supporting structures of the teeth. In this destruction, the host immune response to bacterial products and various inflammatory mediators (cytokines, MMPs) play a role.

MMP-9 plays a significant role in the progression of inflammation and tissue damage. HIF-2 alpha is a factor that regulates bone formation and resorption and is activated in hypoxic or inflammatory environments. TRAP-5b is a specific marker of osteoclast activity and bone resorption. In the literature, there is no study that evaluates these three biomarkers together in saliva samples in the context of periodontal disease.

This study aims to investigate the changes in these salivary biomarkers in the presence of periodontal disease, their diagnostic potential, and their relationship with clinical parameters. The findings may also provide insights for future treatments targeting these cytokine pathways.

Conditions: Periodontal Diseases
Being tested: saliva obtaining
Keywords: periodontitis, gingivitis, saliva, HIF-2a, TRAP-5b, MMP-9, ELISA
Medical subject headings: Periodontal Diseases, Periodontitis, Gingivitis, Erythrocytosis, Familial, 4

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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 salivav 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. Tubes were stored at -80ºC until the day of analysis.

Study groups in NCT07025291
Study group	Role	What they receive
healthy periodontium		According to the evaluation made in 6 areas of each tooth, 20 individuals who showed bleeding on probing in less than 10% of the area, had a probing depth of less than 4 mm and had no attachment loss will be included in the study. Receives: Diagnostic Test: saliva obtaining
Gingivitis		According to the evaluation made in 6 areas of each tooth, 20 individuals who showed bleeding on probing in more than 10% of the area, had a probing depth of less than 4 mm and had no attachment loss will be included in the study. Receives: Diagnostic Test: saliva obtaining
periodontitis		According to the evaluation made in 6 areas of each tooth, 20 individuals who showed bleeding on probing in 30% or more areas, who had a probing pocket depth of 5 mm or more and attachment loss of 4 mm or more in at least 2 non-adjacent teeth in each quadrant jaw, and who had coronal 1/3 or more (horizontal and/or vertical) bone loss on radiographs will be included in the study. Receives: Diagnostic Test: saliva obtaining

What is being measured

The primary outcome is the main question the study is designed to answer.

Salivary HIF-2α levels
the total amount of HIF-2α in saliva
Measured: 24 hours after taking the clinical measurements at the first visit
Salivary TRAP-5b levels
the total amount of TRAP-5b in saliva
Measured: 24 hours after taking the clinical measurements at the first visit
Salivary MMP-9 levels
the total amount of MMP-9 in saliva
Measured: 24 hours after taking the clinical measurements at the first visit

Secondary outcomes (5)

probing depth
With the help of a periodontal probe, the distance between the gingival margin and the sulcus/pocket base will be measured from six points of the tooth: mesiobuccal, midbuccal, distobuccal, mesiopalatinal/lingual, mid buccal/palatinal and distobuccal/palatinal. During the measurement, care will be taken to ensure that the probe is parallel to the long axis of the tooth and that excessive force is not applied. The values will be summed and divided by 6 to calculate the average PD for each patient.
Measured: During the first 1 day visit
clinical attachment level
With the help of a periodontal probe, the distance between the enamel-cement border and the sulcus/pocket base will be measured at six points of the tooth: mesiobuccal, midbuccal, distobuccal, mesiopalatinal/lingual, mid buccal/palatinal and distobuccal/palatinal. The values will be summed and divided by 6 to calculate the average amount of clinical attachment level for each patient.
Measured: During the first 1 day visit
plaque index
For Silness\&Löe plaque index measurement, values will be obtained from four surfaces of each tooth: mesial, distal, vestibular and palatinal. The values will be summed and divided by four to determine the PI score for each tooth. Scoring will be done as follows; 0: No bacterial plaque on the gingival area of the tooth surface. 1: No bacterial plaque is visible on the surface of the tooth by eye, but after probing, bacterial plaque is observed at the tip of the probe. 2: The gingival area is covered with a thin to moderate amount of bacterial plaque, which is visible by eye. 3: There is a large amount of soft debris, the thickness of which completely fills the gingival groove and the interdental space is filled with soft debris.
Measured: During the first 1 day visit
gingival index
According to Löe\&Silness gingival index; vestibule, lingual, mesial and distal surfaces of all teeth will be examined. The values will be summed and divided by four to determine the GI score for each tooth. 0: Healthy gingiva. 1: Mild inflammation, mild discoloration and edema but no bleeding after probing. 2: Moderate inflammation, edema, redness and brightness, bleeding on probing. 3: Severe inflammation and redness, edema, ulceration and tendency to spontaneous bleeding.
Measured: During the first 1 day visit
bleeding on probing
The following index criteria will be used to determine the degree of inflammation in the soft tissue surrounding the vestibular, lingual, mesial and distal surfaces of all teeth. The number of positive (+) scoring areas on the examined surfaces will be calculated as a percentage of the total number of examined areas. (-): No bleeding when the periodontal probe is passed along the gingival sulcus. (+): Bleeding is present at the gingival margin.
Measured: During the first 1 day visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jul 20251 Apr 2026

First posted17 Jun 2025
Study start10 Jul 2025
Primary completion10 Jan 2026
Study completion1 Apr 2026

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: Observational
Observational model: Case-control
Time perspective: Cross-sectional
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07025291
Sponsor's protocol ID: 2024-SAEK-0421
Status last verified: Mar 2026
First submitted: 10 Jun 2025
Last updated: 10 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Periodontal Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Salivary Hypoxia-Inducible Factor -2 Alpha, Matrix Metalloproteinase-9 and Tartrate-Resistant Acid Phosphatase-5b Levels in Individuals With Different Periodontal Diseases
ClinicalTrials.gov ID: NCT07025291
Acronym / sponsor ID: 2024-SAEK-0421
Conditions: Periodontal Diseases
Keywords: periodontitis, gingivitis, saliva, HIF-2a, TRAP-5b, MMP-9, ELISA
Study type: Observational
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Izmir Katip Celebi UniversityUniversity, hospital or other
Study start: 10 Jul 2025 (actual)
Primary completion: 10 Jan 2026 (actual)
Study completion: 1 Apr 2026 (actual)
First posted: 17 Jun 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.

Study design

Observational model: Case-control
Time perspective: Cross-sectional
Number of arms: 3

Arm	Type	Receives
healthy periodontium	–	Diagnostic Test: saliva obtainingAccording to the evaluation made in 6 areas of each tooth, 20 individuals who showed bleeding on probing in less than 10% of the area, had a probing depth of less than 4 mm and had no attachment loss will be included in the study.
Gingivitis	–	Diagnostic Test: saliva obtainingAccording to the evaluation made in 6 areas of each tooth, 20 individuals who showed bleeding on probing in more than 10% of the area, had a probing depth of less than 4 mm and had no attachment loss will be included in the study.
periodontitis	–	Diagnostic Test: saliva obtainingAccording to the evaluation made in 6 areas of each tooth, 20 individuals who showed bleeding on probing in 30% or more areas, who had a probing pocket depth of 5 mm or more and attachment loss of 4 mm or more in at least 2 non-adjacent teeth in each quadrant jaw, and who had coronal 1/3 or more (horizontal and/or vertical) bone loss on radiographs will be included in the study.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Systemically healthy, nonsmoking adults were recruited from individuals attending the Department of Periodontology, Faculty of Dentistry, İzmir Katip Çelebi University. Participants were classified into periodontal health, gingivitis, and periodontitis groups according to the 2017 Classification of Periodontal and Peri-implant Diseases and Conditions. Each group included 20 participants, for a total sample of 60 individuals.

Key inclusion criteria (9 listed)

Systemically healthy (The identification of healthy volunteers will be based on patients' self-reported medical history; no additional diagnostic tests will be conducted.)
Having at least twenty permanent teeth in the mouth
Non-smoker
Not on any continuous medication
No use of antibiotics, anti-inflammatory drugs, or systemic corticosteroids in the last 6 months

Key exclusion criteria (7 listed)

Having any oral or systemic disease
Being on regular systemic medication
Being pregnant or in the lactation period
Having received periodontal treatment within the last 6 months
Having used antibiotics, anti-inflammatory drugs, or systemic corticosteroids 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
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 salivav 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. Tubes were stored at -80ºC until the day of analysis.	Diagnostic test	Gingivitis, healthy periodontium, periodontitis

Primary outcome

Salivary HIF-2α levels
Time frame: 24 hours after taking the clinical measurements at the first visit
the total amount of HIF-2α in saliva
Salivary TRAP-5b levels
Time frame: 24 hours after taking the clinical measurements at the first visit
the total amount of TRAP-5b in saliva
Salivary MMP-9 levels
Time frame: 24 hours after taking the clinical measurements at the first visit
the total amount of MMP-9 in saliva

5 secondary outcomes

probing depth
Time frame: During the first 1 day visit
clinical attachment level
Time frame: During the first 1 day visit
plaque index
Time frame: During the first 1 day visit
gingival index
Time frame: During the first 1 day visit
bleeding on probing
Time frame: During the first 1 day 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 10 Sep 2026.
Individual participant dataSharing planned: No

Related trials for Periodontal Diseases

Not yet recruitingObservational study
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Recruiting
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Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
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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?

An observational study of 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 9 inclusion and 7 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 10 Sep 2026. 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?

Salivary HIF-2α levels (time frame: 24 hours after taking the clinical measurements at the first visit). The study lists 3 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 NCT07025291.

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 10 Sep 2026.