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Periodontal DiseasesNCT06961409

Assessment of Salivary GM-CSF, MIP, and IL-1β Levels in Subjects With Varying Periodontal Conditions

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

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

In order to determine the pathogenesis of chronic inflammatory diseases, the levels of various cytokines are examined in tissues and fluids taken from the body. In recent publications, the role of Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), Macrophage Inflammatory Protein (MIP)-1α and Interleukin… Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Periodontal Diseases, Periodontitis, Gingivitis
What is being tested?
Saliva obtaining
Type of treatment
Injection or infusion
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
14 Aug 2024to 1 Oct 2025
Phase
Observational
Are there results?
Not yet: the study is under way

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 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Systemically healthy, non-smoking adults aged 18-70 years who have not used any medication in the last 6 months, are not pregnant or in the lactation period, and present for routine periodontal examination. Participants are categorized into periodontally healthy, gingivitis, and periodontitis groups based on clinical periodontal parameters

Who may be able to join

  • Systemically healthy participants.
  • At least twenty permanent teeth present in the oral cavity.
  • Non-smokers.
  • No medication for continuous use.
  • Not pregnant or breastfeeding.

Who cannot join

  • Any oral or systemic disease.
  • Regular use of systemic medications.
  • Pregnancy or lactation.
  • Received periodontal treatment within the last 6 months.
  • Use of antibiotics, anti-inflammatory medications, or systemic corticosteroids in the last 6 months.
  • Smokers.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mehmet Sait Bilgiç, Research assistant contact

+905512810621

bilgicsait21@gmail.com

Şükrü Enhoş, Prof. Dr. contact

+905557226198

sukru.enhos@ikc.edu.tr

Turkey (Türkiye)1 site, 1 recruiting
  • Izmir Katip Çelebi University Department of Periodontology

    Izmir, Çiğli, 35640

    Mehmet Sait Bilgiç, +905512810621, bilgicsait21@gmail.com

    Şükrü Enhoş, +905557226198, sukru.enhos@ikc.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of Salivary Granulocyte-Macrophage Colony-Stimulating Factor, Macrophage Inflammatory Protein and Interleukin-1β Levels in Individuals With Different Periodontal Conditions

In order to determine the pathogenesis of chronic inflammatory diseases, the levels of various cytokines are examined in tissues and fluids taken from the body. In recent publications, the role of Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), Macrophage Inflammatory Protein (MIP)-1α and Interleukin (IL)-1β on chronic inflammatory diseases has been investigated. The aim of this study was to evaluate the levels of these cytokines in the saliva of healthy individuals with gingivitis and periodontitis.

All oral clinical parameters of 60 systemically healthy individuals (20 healthy, 20 with gingivitis and 20 with periodontitis) who applied to our clinic for routine periodontal control will be measured and saliva samples will be taken from the patients. GM-CSF, MIP-1α and IL-1β (biomarkers emphasizing inflammation in saliva samples) will be determined by enzyme-linked immunoassay (ELISA). Then, statistical analyses will be performed to interpret the difference in cytokine levels between the groups and the relationship between these cytokines and clinical parameters.

Possible significant differences in cytokine levels will reveal that these proteins and enzymes can be utilized as a diagnostic tool in periodontal diseases, to distinguish periodontal disease status from healthy, or as a guide for treatments.

Read the detailed description

Periodontal disease is characterized by various microbial infections caused by only certain microbial species out of the many types of bacteria present in the oral cavity, with progressive destruction of the tissues supporting the tooth.

Gingivitis is an inflammation caused by substances secreted from microbial plaque accumulated in or near the gingival sulcus, in the gingival tissue surrounding the teeth, and develops due to bacterial plaque. Gingivitis, the mildest form of periodontal disease, is a common condition and can usually be easily treated with good oral hygiene. Gingivitis, as defined, is present in 50% to 90% of adults worldwide. It has been observed that untreated gingivitis lesions are often at risk of developing into periodontitis in individuals. Periodontal disease is a disorder that causes loss of attachment in the tissues surrounding the tooth and destruction of alveolar bone. Periodontitis, which is the main cause of tooth loss in adults, is a common health problem. The initial cause of periodontitis lesions is microbial dental plaque, which is organized on the teeth and contains many pathogenic bacteria. Within the microbial dental plaque, Porphyromonas gingivalis (Pg), Tannerella forsythensis (Tf) and Treponema denticola (Td) play a major role in the formation of active periodontitis lesions.

Although the presence of pathogens is necessary for the onset and progression of periodontal disease, this alone is not sufficient. The host immune response is the main driver of the pathologic process. A dysregulated host immune response or imbalance within the microbial community (dysbiosis) may lead to disruption of homeostasis in the periodontium, leading to destruction of the extracellular matrix and alveolar bone loss. In immune-inflammatory processes triggered by the interaction of host and bacteria, excessive release of proinflammatory cytokines such as IL-1, IL-6, IL-8, prostaglandin E2 (PGE2) and tumor necrosis factor-α (TNF-α) as well as endopeptidases such as matrix metalloproteinases (MMPs) have been found to cause periodontal destruction.

Inflammation in periodontitis and similar local inflammatory lesions and systemic connective tissue diseases causes an increase in biological mediators such as cytokines, prostaglandins and matrix metalloproteinases (MMPs) in the tissues involved and in the systemic circulation.

Members of the colony-stimulating factor (CSF) superfamily are involved in mammalian myelopoiesis, i.e. the formation of monocytes, macrophages, dendritic cells (DCs) and polymorphonuclear phagocytes (neutrophils and eosinophils). There are three main members of this family: Macrophage (M)-CSF (or CSF-1), Granulocyte (G)-CSF (or CSF-3) and Granulocyte-Macrophage (GM)-CSF (or CSF-2). They were first identified as growth factors capable of promoting myeloid colony formation from bone marrow precursors in vitro. In these three CSFs, the entire structure of phagocytes can potentially be controlled . GM-CSF, as its name suggests, was initially identified as a hematopoietic growth factor due to its ability to induce the differentiation of granulocytes and macrophages in vitro by inducing the proliferation and differentiation of bone marrow progenitor cells. However, it was later seen as a cytokine that acts through a specific receptor on myeloid cell populations such as monocytes/macrophages, neutrophils and eosinophils, activating/differentiating them and having a potential role in inflammation.Data from models of autoimmunity and chronic inflammation using mice lacking the GM-CSF gene or neutralizing monoclonal antibodies (mAbs) suggest that GM-CSF may be an important driver of tissue inflammation and associated pain. Examples include arthritis, EAE (Induced Experimental Autoimmune Encephalomyelitis), cardiovascular disease and lung disease. GM-CSF was one of the first cytokines detected in inflamed human synovial fluid and its biological effects outside the bone marrow vary depending on its location and concentration.

The role of this cytokine in regulating inflammation has made it attractive targets for therapeutic interventions, especially in the treatment of chronic inflammation and cancer. Many of these strategies target GM-CSF for its inflammatory properties. Understanding the cellular and molecular mechanisms by which GM-CSF exerts these diverse effects is essential for the development of better therapies for chronic inflammatory diseases. Antibodies targeting GM-CSF or its receptor GMRa are currently in early-stage clinical development for the treatment of rheumatoid arthritis and multiple sclerosis.

In a study by Zhu et al, salivary levels of GM-CSF were found to be specifically elevated in the erosive oral lichen planus group. GM-CSF has been shown to increase matrix metalloproteinase expression in monocyte-macrophages and in some cases may lead to the development of bone resorbing osteoclast precursors.

Macrophage Inflammatory Protein (MIP)-1α was first identified in 1988 as MIP-1α, an 8-kd protein pair partially purified from endotoxin-stimulated macrophages. MIP-1α is a C-C family chemokine that is a potent chemoattractant for monocytes and can be stimulated by lipopolysaccharide (LPS). It was named macrophage inflammatory protein because it induces neutrophil accumulation when injected into the footpads of mice.

MIP-1α is produced by cells during infection or inflammation. MIP-1α expression can be induced in various cell types including monocytes, macrophage cell lines, mast cell lines, Langerhans cells, fibroblasts and T lymphocytes.

MIP-1α plays an important role in the pathogenesis of various inflammatory diseases and conditions such as periodontitis, multiple myeloma, Sjögren's syndrome and rheumatoid arthritis . They fulfill various biological functions such as recruitment of inflammatory cells, wound healing, inhibition of stem cells and maintenance of effector immune response. MIP-1α promotes the orientation and movement of osteoclasts. It initiates the process of osteoclastogenesis by directly activating osteoclast cells.

In bone marrow samples from patients with Multiple Myeloma, MIP-1α/CCL3 mRNA expression is higher compared to healthy individuals. There is a strong positive correlation between bone resorption markers such as serum bone-specific alkaline phosphatase (S-BALP) and serum MIP-1α levels in patients with multiple lytic bone lesions.

MIP-1α has recently been shown to play a role in the regulation of tumor metastasis.

Oral squamous cell carcinoma (OSCC) patients with metastatic lymph nodes had increased MIP-1α mRNA expression compared to those with non-metastatic lymph nodes. This suggests a possible role of MIP-1α in tumor migration.

In a study conducted by Petkovic et al. in which peri-implant groove fluid was evaluated, MIP-1α values were found to be higher in peri-implant mucositis groups compared to healthy control group patients. In the same study, the mean peri-implant groove fluid values of MIP-1α were found to be statistically significantly higher in the group with advanced mucositis compared to the group with early mucositis.

IL-1, the first interleukin identified, has many biological activities. In fact, before the molecular identification of IL-1 in the mid-1980s, various biological functions of this cytokine had been studied for many years under different names such as leukocyte endogenous mediator, hematopoietin 1, endogenous pyrogen, catabolin and osteoclast activating factor. In the last decade, other members of the IL-1 family have been identified and their important roles in innate and adaptive immune responses have been established.

Many aspects of the diverse biological roles of IL-1α and its functional homolog but structurally distinct relative IL-1β have been elucidated by the Dinarello laboratory. IL-1α and IL-1β are key members of the IL-1 family, which currently consists of eleven members. IL-1α and IL-1β are key proinflammatory cytokines that exert pleiotrophic effects in various cells and play critical roles in both acute and chronic inflammatory and autoimmune disorders. These cytokines interact with two types of receptors, IL-1 type 1 receptor (IL-1RI) and IL-1 type 2 receptor (IL-1 RII).

IL-1α and IL-1β carry out signal transduction through IL-1RI. IL-1β has important homeostatic functions in the normal organism such as regulation of nutrition, sleep and temperature. However, overproduction of IL-1β is involved in pathophysiological changes that occur in different disease states such as rheumatoid arthritis, neuropathic pain, inflammatory bowel disease, osteoarthritis, vascular disease, multiple sclerosis and Alzheimer's disease. IL-1β can be released from immune cells such as keratinocytes, fibroblasts, synoviocytes, endothelial, neuronal, macrophages and mast cells and glial cells such as Schwann cells, microglia and astrocytes.

IL-1β plays a key role in the regulation of the innate immune response and underlies autoinflammatory diseases such as cryopyrin-associated periodic syndromes (CAPS) and familial Mediterranean fever (FMF).

In a study by Fonseca et al. in which peri-implant groove fluid was evaluated, the IL-1β value in peri-implant groove fluid of peri-implantitis regions was higher than that of peri-implant mucositis regions. Curtis et al. showed that IL-1β measurement can make an important contribution to clinical findings in the diagnosis of peri-implantitis.

Relvas et al. observed that salivary IL-1β levels were higher in periodontitis stage III/IV patients than in periodontally healthy control patients and periodontitis stage I/II patients. In addition, IL-1β was found to be especially prominent in patients with grade C periodontitis and positively correlated with bone loss.

Saliva contains electrolytes such as sodium, potassium, calcium, magnesium, bicarbonate and phosphate. In addition, saliva contains immunoglobulins, proteins, enzymes, mucins and the nitrogenous compounds urea and ammonia. In recent years, saliva has been increasingly recognized as a useful tool in ancillary diagnostic methods. Sialometry and sialochemistry techniques are used in the diagnosis of systemic diseases, in the follow-up of general health status and as a risk indicator for diseases that determine the relationship between oral health and systemic health.

Saliva has been identified as an effective tool for screening and monitoring periodontitis because it is easily collectable and can reflect the inflammatory status of the whole mouth. Indeed, various cytokines and immune mediators present in saliva have been associated with inflammatory processes that progress with unstable responses.

To the best of the author's knowledge, no studies have evaluated salivary GM-CSF and MIP-1α levels in relation to periodontal disease in the existing literature. This study aimed to investigate the changes of these cytokines in the presence of periodontal disease by comparatively examining the levels of GM-CSF, MIP-1α and IL-1β in saliva samples obtained from healthy individuals with gingivitis and periodontitis, to show their potential to be used in the diagnosis of the disease or to provide preliminary information for future treatments that may be performed through these cytokine pathways.

Being tested
Saliva obtaining
Medical subject headings
Periodontal Diseases, Periodontitis, Gingivitis

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 saliva 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.

  • 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 saliva 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.

  • 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 saliva 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 NCT06961409
Study groupRoleWhat they receive
Healthy PeriodontiumFull-mouth clinical periodontal measurements recorded and saliva obtained.
Receives: Diagnostic Test: Saliva obtaining
GingivitisFull-mouth clinical periodontal measurements recorded and saliva obtained.
Receives: Diagnostic Test: Saliva obtaining
PeriodontitisFull-mouth clinical periodontal measurements recorded and saliva obtained.
Receives: Diagnostic Test: Saliva obtaining

What is being measured

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

  1. Salivary level of GM- CSF

    Amount of GM-CSF in human saliva

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

  2. Salivary level of MIP-1α

    Amount of MIP-1α in human saliva

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

  3. Salivary level of IL-1β

    Amount of IL-1β in human saliva

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

Secondary outcomes (5)
  1. 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: At the initial visit.

  2. Periodontal Probing Depth

    Distance between the gingival margin and sulcus/pocket floor

    Measured: At the initial visit.

  3. Clinical Attachment Level

    Distance between the enamel-cement junction and the sulcus/base of the pocket.

    Measured: At the initial visit.

  4. Plaque Index

    For 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 has completely filled the gingival groove and the interdental space is filled with soft debris.

    Measured: At the initial visit.

  5. Gingival Index

    The 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: At the initial visit.

Timeline

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

  1. First posted7 May 2025
  2. Study start14 Aug 2024
  3. Primary completion1 Aug 2025 (estimated)
  4. Study completion1 Oct 2025 (estimated)

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
Other
Time perspective
Cross-sectional
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06961409
Sponsor's protocol ID
2024--SAEK-0039
Status last verified
Apr 2025
First submitted
29 Apr 2025
Last updated
7 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The individual participant data (IPD) collected during the study will not be shared with other researchers or made publicly available. Only summarized results will be disseminated through publications or presentations.

Questions about this trial

What is this clinical trial studying?

An observational study of Periodontal Diseases and Periodontitis, 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 7 May 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mehmet Sait Bilgiç, Research assistant (+905512810621, bilgicsait21@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Salivary level of GM- CSF (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?
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 7 May 2025.

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