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Completed

NCT Number: NCT07025291

Assessment of Salivary Biomarker Levels in Individuals With Various 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.

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.

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Key information

Conditions

Periodontal Diseases Erythrocytosis, Familial, 4 Gingival Diseases Gingivitis Infections Mouth Diseases Periodontitis Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Izmir Katip Celebi University Faculty of Dentistry

Izmir, Cigli, 35640, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • 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

Treatment and study plan

saliva obtaining

Diagnostic 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.

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. probing depth

    Time frame: During the first 1 day visit

    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.

  2. clinical attachment level

    Time frame: During the first 1 day visit

    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.

  3. plaque index

    Time frame: During the first 1 day visit

    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.

  4. gingival index

    Time frame: During the first 1 day visit

    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.

  5. bleeding on probing

    Time frame: During the first 1 day visit

    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.

Sponsors and collaborators

Lead sponsor

Izmir Katip Celebi University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 17, 2025
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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