PeriodontitisNCT06430450
Determination of Salivary Soluble Urokinase Plasminogen Activator Receptor (SuPAR), Hypoxia-inducible Factor-1 Alpha (HIF-1α), E-cadherin, Galectin 3, IL-4, IL-10 and TNF-α Levels in Individuals With Different Degrees of Periodontal Disease
An observational study of Periodontitis and Periodontal Diseases, run by Karamanoğlu Mehmetbey University.
Trial summary
The aim of this clinical study is; Comparatively comparing salivary Soluble Urokinase Plasminogen Activator Receptor (SuPAR), Hypoxia-inducible factor-1 alpha (HIF-1α), E-cadherin, galectin 3, IL-4, IL-10 and TNF-α levels in individuals with different Periodontal Disease Degrees and to evaluate and analyze… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Periodontal Diseases
- What is being tested?
- Clinical measurements and saliva samples collection
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2024to 15 Jan 2025
- How long will I take part?
- 5 Months
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * 20 healty patients * 20 Grade A periodontitis * 20 Grade B periodontitis * 20 Grade C periodontitis
Who may be able to join
- Patients with a varying degree of periodontal status (periodontally healthy, gingivitis, and chronic periodontitis).
- Have no systemic disease.
- No smoking/ not using any tobacco products or alcohol.
- No periodontal therapy in last 6 months.
- Not using any anti-inflammatory drugs in last 3 months and antibiotics in last 6 months.
- Not to be pregnant or in lactation period.
- Having ≥20 permanent teeth.
Who cannot join
- Having any systemic disease.
- Smokers, other tobacco product, and alcohol consumers.
- Having any periodontal therapy in last 6 months.
- Using any anti-inflammatory drugs in last 3 months and antibiotics in last 6 months.
- Being pregnant or in lactation period.
- Having ˂20 permanent teeth.
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this clinical study is; Comparatively comparing salivary Soluble Urokinase Plasminogen Activator Receptor (SuPAR), Hypoxia-inducible factor-1 alpha (HIF-1α), E-cadherin, galectin 3, IL-4, IL-10 and TNF-α levels in individuals with different Periodontal Disease Degrees and to evaluate and analyze correlations with clinical parameters. In our study, saliva samples will be taken from a total of 80 systemically healthy volunteers, 20 of patients are periodontal healthy, 20 of patients have degree A periodontitis, 20 of patients have degree B periodontitis and 20 of patients have degree C periodontitis, along with the measurement of whole mouth clinical parameters. Soluble Urokinase Plasminogen Activator Receptor (SuPAR), Hypoxia-inducible factor-1 alpha (HIF-1α), E-cadherin, galectin 3, IL-4, IL-10 and TNF-α levels in the samples taken will be subjected to enzyme-related immunoassay ( It will be determined by ELISA). Cytokine levels between different groups will then be interpreted as a result of statistical analysis. Possible significant differences shed light on future studies with Soluble Urokinase Plasminogen Activator Receptor (SuPAR), Hypoxia-inducible factor-1 alpha (HIF-1α), E-cadherin, galectin 3, IL-4, IL-10 and TNF-α. These cytokines may help develop different diagnostic methods or treatment strategies in future periodontal treatments.
Read the detailed description
The study included patients between the ages of 18 and 70 who applied to Karamanoğlu Mehmetbey University Ahmet Keleşoğlu Faculty of Dentistry Department of Periodontology, were non-smokers, had no systemic problems, had not used antibiotics, anti-inflammatory and systemic corticosteroid drugs in the last 3 months, were not pregnant, had not received periodontal treatment in the last 6 months, and having at least 20 teeth in its mouth; for grade A periodontitis group; 20 individuals with a probing pocket depth of 5 mm or more in at least 2 teeth in each quadrant of the jaw, attachment loss, and radiological bone loss percentage/age ratio <0.25 in the tooth with the most bone loss; for grade B periodontitis group; 20 individuals with a probing pocket depth of 5 mm or more in at least 2 teeth in each quadrant jaw, attachment loss, and a radiological bone loss percentage/age ratio of 0.25-1.0 in the tooth with the most bone loss; for grade C periodontitis group; 20 individuals with a probing pocket depth of 5 mm or more in at least 2 teeth in each quadrant of the jaw, attachment loss, and radiological bone loss percentage/age ratio >1.0 in the tooth with the most bone loss; For the healthy group; According to the evaluation made in 6 regions of each tooth, including 20 individuals who show bleeding on probing in less than 20% of the area, have a probing depth of less than 4 mm, and have no attachment loss. The healthy and periodontal disease group will consist of 80 patients in total.Anamnesis will be taken from individuals at the beginning of the interview, and individuals who meet the specified criteria after the anamnesis will be included in the study. After being informed about the study, an informed consent form will be obtained from the individuals.
After the anamnesis is taken, clinical periodontal evaluations will be performed on individuals who are deemed to meet the inclusion criteria. Clinically, plaque index (Sillness and Löe 1964), gingival index (Löe and Sillness 1963), pocket depth and bleeding on probing index(Ainamo\&Bay, 1975) will be recorded.
Saliva samples will be taken from individuals divided into groups for biochemical examinations. Saliva samples will be taken from each patient, first frozen at -20ºC and than stored at -28ºC until the day of analysis. Cytokine levels in the samples collected from the patients will be determined by the enzyme-related immune test "Enzyme Linked-Immuno-Sorbent Assay" (ELISA).
- Conditions
- Periodontitis, Periodontal Diseases
- Being tested
- Clinical measurements and saliva samples collection
- Keywords
- Periodontitis, Saliva, Cytokine
- Medical subject headings
- Periodontitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical measurements and saliva samples collectionDiagnostic test
Clinical measurements will be taken from all patients and saliva samples will be collected for biochemical analysis.
| Study group | Role | What they receive |
|---|---|---|
| Healty | Individuals who have no clinical signs of inflammation in the periodontal tissues and the number of areas showing bleeding on probing does not exceed 20%. Receives: Diagnostic Test: Clinical measurements and saliva samples collection | |
| Grade A | Individuals with a probing pocket depth of 5 mm or more in at least 2 teeth in each quadrant of the jaw, attachment loss, and radiological bone loss percentage/age ratio in the tooth with the most bone loss <0.25 Receives: Diagnostic Test: Clinical measurements and saliva samples collection | |
| Grade B | Individuals with a probing pocket depth of 5 mm or more in at least 2 teeth in each quadrant jaw, attachment loss, and a radiological bone loss percentage/age ratio of 0.25-1.0 in the tooth with the most bone loss. Receives: Diagnostic Test: Clinical measurements and saliva samples collection | |
| Grade C | Individuals with a probing pocket depth of 5 mm or more in at least 2 teeth in each quadrant of the jaw, attachment loss, and a radiological bone loss percentage/age ratio >1.0 in the tooth with the most bone loss. Receives: Diagnostic Test: Clinical measurements and saliva samples collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome 1
Comparatively comparing salivary Soluble Urokinase Plasminogen Activator Receptor (SuPAR), Hypoxia-inducible factor-1 alpha (HIF-1α), E-cadherin, galectin 3, IL-4, IL-10 and TNF-α levels in individuals with different Periodontal Disease Degrees. To examine and determine the correlation of these cytokines with clinical measurements.
Measured: First 5 months
Secondary outcomes (1)
Outcome 2
By investigating the changes in these cytokine levels in the presence of periodontal disease, they can be used in disease diagnosis in the future or to provide preliminary information on possible treatments that can be performed through these cytokine pathways.
Measured: Two months after the study was completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start15 Jul 2024 (estimated)
- Primary completion15 Nov 2024 (estimated)
- Study completion15 Jan 2025 (estimated)
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 5 Months
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İsmail Taşdemir, Karamanoğlu Mehmetbey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06430450
- Sponsor's protocol ID
- ISMAILKMU
- Status last verified
- May 2024
- First submitted
- 21 May 2024
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tasdemir I, Ozgoren O, Yilmaz HE, Kartal E, Altunyaprak S, Saglam M. Salivary levels of suPAR, HIF-1alpha and TNF-alpha in different grades of stage III periodontitis. BMC Oral Health. 2025 May 22;25(1):760. doi: 10.1186/s12903-025-06155-3.
PubMed 40405145
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Salivary Soluble Urokinase Plasminogen Activator Receptor (SuPAR), Hypoxia-inducible Factor-1 Alpha (HIF-1α), E-cadherin, Galectin 3, IL-4, IL-10 and TNF-α Levels in Individuals With Different Degrees of Periodontal Disease
- ClinicalTrials.gov ID
- NCT06430450
- Acronym / sponsor ID
- ISMAILKMU
- Conditions
- Periodontitis, Periodontal Diseases
- Keywords
- Periodontitis, Saliva, Cytokine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Study start
- 15 Jul 2024 (estimated)
- Primary completion
- 15 Nov 2024 (estimated)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 28 May 2024 (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.
The aim of this clinical study is; Comparatively comparing salivary Soluble Urokinase Plasminogen Activator Receptor (SuPAR), Hypoxia-inducible factor-1 alpha (HIF-1α), E-cadherin, galectin 3, IL-4, IL-10 and TNF-α levels in individuals with different Periodontal Disease Degrees and to evaluate and analyze correlations with clinical parameters. In our study, saliva samples will be taken from a total of 80 systemically healthy volunteers, 20 of patients are periodontal healthy, 20 of patients have degree A periodontitis, 20 of patients have degree B periodontitis and 20 of patients have degree C periodontitis, along with the measurement of whole mouth clinical parameters. Soluble Urokinase Plasminogen Activator Receptor (SuPAR), Hypoxia-inducible factor-1 alpha (HIF-1α), E-cadherin, galectin 3, IL-4, IL-10 and TNF-α levels in the samples taken will be subjected to enzyme-related immunoassay ( It will be determined by ELISA). Cytokine levels between different groups will then be interpreted as a result of statistical analysis. Possible significant differences shed light on future studies with Soluble Urokinase Plasminogen Activator Receptor (SuPAR), Hypoxia-inducible factor-1 alpha (HIF-1α), E-cadherin, galectin 3, IL-4, IL-10 and TNF-α. These cytokines may help develop different diagnostic methods or treatment strategies in future periodontal treatments.
Detailed description
The study included patients between the ages of 18 and 70 who applied to Karamanoğlu Mehmetbey University Ahmet Keleşoğlu Faculty of Dentistry Department of Periodontology, were non-smokers, had no systemic problems, had not used antibiotics, anti-inflammatory and systemic corticosteroid drugs in the last 3 months, were not pregnant, had not received periodontal treatment in the last 6 months, and having at least 20 teeth in its mouth; for grade A periodontitis group; 20 individuals with a probing pocket depth of 5 mm or more in at least 2 teeth in each quadrant of the jaw, attachment loss, and radiological bone loss percentage/age ratio <0.25 in the tooth with the most bone loss; for grade B periodontitis group; 20 individuals with a probing pocket depth of 5 mm or more in at least 2 teeth in each quadrant jaw, attachment loss, and a radiological bone loss percentage/age ratio of 0.25-1.0 in the tooth with the most bone loss; for grade C periodontitis group; 20 individuals with a probing pocket depth of 5 mm or more in at least 2 teeth in each quadrant of the jaw, attachment loss, and radiological bone loss percentage/age ratio >1.0 in the tooth with the most bone loss; For the healthy group; According to the evaluation made in 6 regions of each tooth, including 20 individuals who show bleeding on probing in less than 20% of the area, have a probing depth of less than 4 mm, and have no attachment loss. The healthy and periodontal disease group will consist of 80 patients in total.Anamnesis will be taken from individuals at the beginning of the interview, and individuals who meet the specified criteria after the anamnesis will be included in the study. After being informed about the study, an informed consent form will be obtained from the individuals.
After the anamnesis is taken, clinical periodontal evaluations will be performed on individuals who are deemed to meet the inclusion criteria. Clinically, plaque index (Sillness and Löe 1964), gingival index (Löe and Sillness 1963), pocket depth and bleeding on probing index(Ainamo\&Bay, 1975) will be recorded.
Saliva samples will be taken from individuals divided into groups for biochemical examinations. Saliva samples will be taken from each patient, first frozen at -20ºC and than stored at -28ºC until the day of analysis. Cytokine levels in the samples collected from the patients will be determined by the enzyme-related immune test "Enzyme Linked-Immuno-Sorbent Assay" (ELISA).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healty | – | Diagnostic Test: Clinical measurements and saliva samples collectionIndividuals who have no clinical signs of inflammation in the periodontal tissues and the number of areas showing bleeding on probing does not exceed 20%. |
| Grade A | – | Diagnostic Test: Clinical measurements and saliva samples collectionIndividuals with a probing pocket depth of 5 mm or more in at least 2 teeth in each quadrant of the jaw, attachment loss, and radiological bone loss percentage/age ratio in the tooth with the most bone loss <0.25 |
| Grade B | – | Diagnostic Test: Clinical measurements and saliva samples collectionIndividuals with a probing pocket depth of 5 mm or more in at least 2 teeth in each quadrant jaw, attachment loss, and a radiological bone loss percentage/age ratio of 0.25-1.0 in the tooth with the most bone loss. |
| Grade C | – | Diagnostic Test: Clinical measurements and saliva samples collectionIndividuals with a probing pocket depth of 5 mm or more in at least 2 teeth in each quadrant of the jaw, attachment loss, and a radiological bone loss percentage/age ratio >1.0 in the tooth with the most bone loss. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * 20 healty patients * 20 Grade A periodontitis * 20 Grade B periodontitis * 20 Grade C periodontitis
Key inclusion criteria (7 listed)
- Patients with a varying degree of periodontal status (periodontally healthy, gingivitis, and chronic periodontitis).
- Have no systemic disease.
- No smoking/ not using any tobacco products or alcohol.
- No periodontal therapy in last 6 months.
- Not using any anti-inflammatory drugs in last 3 months and antibiotics in last 6 months.
Key exclusion criteria (6 listed)
- Having any systemic disease.
- Smokers, other tobacco product, and alcohol consumers.
- Having any periodontal therapy in last 6 months.
- Using any anti-inflammatory drugs in last 3 months and antibiotics in last 6 months.
- Being pregnant or in lactation period.
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 |
|---|---|---|
| Clinical measurements and saliva samples collectionClinical measurements will be taken from all patients and saliva samples will be collected for biochemical analysis. | Diagnostic test | Grade A, Grade B, Grade C, Healty |
Primary outcome
Outcome 1
Time frame: First 5 months
Comparatively comparing salivary Soluble Urokinase Plasminogen Activator Receptor (SuPAR), Hypoxia-inducible factor-1 alpha (HIF-1α), E-cadherin, galectin 3, IL-4, IL-10 and TNF-α levels in individuals with different Periodontal Disease Degrees. To examine and determine the correlation of these cytokines with clinical measurements.
1 secondary outcome
Outcome 2
Time frame: Two months after the study was completed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Derived from this study: PubMed 40405145Tasdemir I, Ozgoren O, Yilmaz HE, Kartal E, Altunyaprak S, Saglam M. Salivary levels of suPAR, HIF-1alpha and TNF-alpha in different grades of stage III periodontitis. BMC Oral Health. 2025 May 22;25(1):760. doi: 10.1186/s12903-025-06155-3.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis and Periodontal Diseases, run by Karamanoğlu Mehmetbey University.
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 7 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: status not confirmed, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ismail taşdemir, assistant professor (+905455694573, drismailtasdemir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome 1 (time frame: First 5 months). 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 NCT06430450, 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 28 May 2024.