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Periodontal DiseasesNCT07025291

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.

Official record
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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

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 disease from a healthy condition. It will be evaluated whether these biochemical mediators can be used as diagnostic biomarkers in the diagnosis of periodontal disease.

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.

Read more

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.

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 groupRoleWhat they receive
healthy periodontiumAccording 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
GingivitisAccording 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
periodontitisAccording 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.

  1. Salivary HIF-2α levels

    the total amount of HIF-2α in saliva

    Measured: 24 hours after taking the clinical measurements at the first visit

  2. Salivary TRAP-5b levels

    the total amount of TRAP-5b in saliva

    Measured: 24 hours after taking the clinical measurements at the first visit

  3. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  1. First posted17 Jun 2025
  2. Study start10 Jul 2025
  3. Primary completion10 Jan 2026
  4. Study completion1 Apr 2026

Resources

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

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.

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