Diabetes MellitusNCT06735313
Changes in Salivary Asprosin, IL-39, IL-40 and IL-1β Levels in Diabetic Patients with Periodontitis
A study testing Periodontal examination and saliva collection in people with Diabetes Mellitus and Periodontal Disease, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the relationships between asprosin, IL-39, IL-40 and IL-1β in saliva between individuals with and without diabetes and between individuals with periodontitis and healthy individuals and to determine the potential roles of these biomarkers that are multiplied in periodontal… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Periodontal Disease, Asprosin
- What is being tested?
- Periodontal examination and saliva collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2025to 20 Feb 2025
- Phase
- Interventional
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having a periodontally healthy diagnosis in routine clinical and radiographic examinations Inclusion criteria for the periodontitis group
- Diagnosing periodontitis in routine clinical and radiographic examinations
Who cannot join
- - Patients with any autoimmune disease (Rheumatoid arthritis, familial Mediterranean fever, ankylosing spondylitis, Behcet, psoriasis, etc.) - Those who smoke 10 or more cigarettes per day
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Necmettin Erbakan University
Konya, Meram, 42090
ayşe hümeyra oruç, +90332 220 00 26, ayse61836@gmail.com
Ayşe hümeyra Oruç
About this study
Official title: Evaluation of Salivary Asprosin, IL-39,IL-40 and IL-1β Levels in Diabetic Patients with Periodontitis
The aim of this study is to determine the relationships between asprosin, IL-39, IL-40 and IL-1β in saliva between individuals with and without diabetes and between individuals with periodontitis and healthy individuals and to determine the potential roles of these biomarkers that are multiplied in periodontal disease. The study aims to evaluate whether these biomarkers can be used for periodontal diagnosis or prognosis.
The questions answered by the study are as follows:
Do asprosin, IL-39, IL-40 and IL-1β biomarker levels differ between individuals with and without diabetes? Do these biomarker levels differ significantly between individuals with periodontitis and individuals who are healthy? Can these biomarkers be used in the early diagnosis or recording the progression of periodontal diseases?
Read the detailed description
The study is planned to be conducted with 176 individuals with and without periodontal disease between the ages of 18-80 who come to the Department of Periodontics of the Faculty of Dentistry of Necmettin Erbakan University for treatment. Those who sign the 'informed consent form' will be included in the study.
In the periodontal examination of each patient who applies to the periodontology clinic, routine radiographic and clinical evaluations are performed, and routine periodontal status records (periodontal pocket depths of the teeth, attachment losses, mobility levels, furcation defect degrees, bleeding index on probing, gingival index, plaque index, amount of keratinized gingiva, gingival recessions, body/mass index) are taken and archived before the start of the patients' treatments and after each planned treatment. In addition, the sociodemographic data and brushing habits of each patient who will participate in the study are recorded. Saliva samples will also be collected from patients prior to treatment. Individuals will be divided into groups according to their periodontal disease status:
- 44 periodontally healthy, systemically healthy individuals
- 44 periodontally healthy, type 2 diabetic individuals
- 44 periodontitis, systemically healthy individuals
- 44 periodontitis, type 2 diabetic individuals
A calibrated expert clinician will determine periodontal status according to the criteria of the 2017 World Workshop on Classification of Periodontal and Peri-Implant Diseases and Conditions based on radiographic and clinical examination. Patients will need to meet the criteria for Stage II and III, generalized, periodontitis to be included in the periodontitis groups.
Saliva samples will be collected before periodontal measurements are taken to prevent saliva from bleeding during probing. Participants will be asked not to brush their teeth at least one hour before the sample collection and to avoid any food, sugary gum, cosmetic products such as lipstick, and any medication that will not affect the salivary hormone measurements. A total of 5 2 ml samples, one for each marker, will be collected from each patient between 9:00 and 10:00 in the morning. The samples will be collected in plastic tubes with a glass funnel within five minutes after each participant rinses their mouth with water. The tubes will then be capped and the samples will be centrifuged at 1000 rpm for 10 minutes to remove cellular elements and plaque. The supernatant liquid will be pipetted without touching the sediment formed at the bottom of the tubes, placed in polypropylene Eppendorf tubes, and stored at -20°C until analysis.
Analysis of Saliva Samples Samples will be placed at +4°C to be thawed on the day of analysis. ELISA kits will be used to determine Asprosin, IL-39,IL-40, IL-38 and IL-1B levels according to the manufacturer's instructions (Elabscience Biotechnology Co. Ltd).
Statistical Analysis Statistical analysis will be performed using the Statistical Package for Social Sciences (SPSS) version 23 (IBM Corp., Armonk, NY).
Data will be expressed as mean and standard deviation. Data normality will be assessed using the Kolmogorov-Smirnov test. Differences between parameter means in intragroup comparisons of periodontally healthy and periodontitis groups will be assessed using the One-way ANOVA (Bonferroni post-hoc) test. Differences between parameter means between periodontally healthy and periodontitis groups will be assessed using the independent t test. Pearson correlation coefficients will be used to assess correlations between clinical and biochemical parameters. Areas under the curve (AUC) and receiver operating characteristic (ROC) curves will be used to examine the sensitivity and specificity of salivary biomarkers in distinguishing periodontitis from periodontal health. p<0.05 will be considered statistically significant.
- Conditions
- Diabetes Mellitus, Periodontal Disease, Asprosin, Interleukin 1-beta
- Being tested
- Periodontal examination and saliva collection
- Medical subject headings
- Diabetes Mellitus, Periodontal Diseases, Arachnodactyly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal examination and saliva collectionDiagnostic test
Before the periodontal examination, saliva samples are collected from each patient participating in the study and periodontal measurements are made.
| Study group | Role | What they receive |
|---|---|---|
| Periodontally healthy, systemically healthy individual | Other | Before starting the treatment of the patients and after each planned treatment, routine periodontal status records (periodontal pocket depths of the teeth, attachment losses, mobility levels, furcation defect degrees, bleeding index on probing, gingival index, plaque index, amount of keratinized gingiva, gingival recession, body/mass index) are taken and archived. In addition, sociodemographic data and brushing habits of each patient participating in the study are recorded. Saliva samples will also be collected from the patients before the treatment. Receives: Diagnostic Test: Periodontal examination and saliva collection |
| periodontally healthy individuals with type 2 diabetes | Active comparator | Before starting the treatment of the patients and after each planned treatment, routine periodontal status records (periodontal pocket depths of the teeth, attachment losses, mobility levels, furcation defect degrees, bleeding index on probing, gingival index, plaque index, amount of keratinized gingiva, gingival recession, body/mass index) are taken and archived. In addition, sociodemographic data and brushing habits of each patient participating in the study are recorded. Saliva samples will also be collected from the patients before the treatment. Receives: Diagnostic Test: Periodontal examination and saliva collection |
| Systemically healthy individual with periodontitis | Active comparator | Before starting the treatment of the patients and after each planned treatment, routine periodontal status records (periodontal pocket depths of the teeth, attachment losses, mobility levels, furcation defect degrees, bleeding index on probing, gingival index, plaque index, amount of keratinized gingiva, gingival recession, body/mass index) are taken and archived. In addition, sociodemographic data and brushing habits of each patient participating in the study are recorded. Saliva samples will also be collected from the patients before the treatment. Receives: Diagnostic Test: Periodontal examination and saliva collection |
| Individual with periodontitis and type 2 diabetes | Active comparator | Before starting the treatment of the patients and after each planned treatment, routine periodontal status records (periodontal pocket depths of the teeth, attachment losses, mobility levels, furcation defect degrees, bleeding index on probing, gingival index, plaque index, amount of keratinized gingiva, gingival recession, body/mass index) are taken and archived. In addition, sociodemographic data and brushing habits of each patient participating in the study are recorded. Saliva samples will also be collected from the patients before the treatment. Receives: Diagnostic Test: Periodontal examination and saliva collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of preoperative periodontal parameters
To determine the baseline condition, preoperative measurement of periodontal parameters (amount of keratinized tissue, papilla height, papilla width, probing pocket depth, amount of recession, tissue thickness) will be recorded in millimeters using a periodontal probe.
Measured: before collecting saliva
gingival index measurement
The status of gingival health will be assessed using the Gingival Index (Loe and Silness, 1963). This measurement will be made to determine the degree of gingival inflammation and will be scored on a scale from 0 (healthy gingiva) to 3 (severe inflammation and bleeding).
Unit of Measurement: 0-3 scale.
Measured: before collecting saliva
Plaque Index (PI) measurement
The degree of plaque accumulation on the tooth surfaces will be assessed using the Plaque Index (Silness and Loe, 1964). The assessment will be made on a scale from 0 (no plaque) to 3 (entire tooth surface covered with plaque). This measurement will be used to objectively determine the degree of plaque formation.Unit of Measurement: 0-3 scale.
Measured: before collecting saliva
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start10 Jan 2025 (estimated)
- Primary completion10 Feb 2025 (estimated)
- Study completion20 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AYSE HUMEYRA ORUC, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735313
- Sponsor's protocol ID
- periodontitisanddiabetes
- Status last verified
- Dec 2024
- First submitted
- 11 Dec 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gul SNS, Eminoglu DO, Laloglu E, Aydin T, Dilsiz A. Salivary and serum asprosin hormone levels in the 2018 EFP/AAP classification of periodontitis stages and body mass index status: a case-control study. Clin Oral Investig. 2024 Jan 13;28(1):91. doi: 10.1007/s00784-024-05494-9.
PubMed 38217801Oruc AH, Babayigit O. Salivary asprosin, IL-39, IL-40, and IL-1beta levels in diabetic patients with periodontitis: A cross-sectional analysis. Clin Oral Investig. 2026 Jan 14;30(1):52. doi: 10.1007/s00784-026-06744-8.
PubMed 41530539
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Salivary Asprosin, IL-39,IL-40 and IL-1β Levels in Diabetic Patients with Periodontitis
- ClinicalTrials.gov ID
- NCT06735313
- Acronym / sponsor ID
- periodontitisanddiabetes
- Conditions
- Diabetes Mellitus, Periodontal Disease, Asprosin, Interleukin 1-beta
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 10 Jan 2025 (estimated)
- Primary completion
- 10 Feb 2025 (estimated)
- Study completion
- 20 Feb 2025 (estimated)
- First posted
- 16 Dec 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 study is to determine the relationships between asprosin, IL-39, IL-40 and IL-1β in saliva between individuals with and without diabetes and between individuals with periodontitis and healthy individuals and to determine the potential roles of these biomarkers that are multiplied in periodontal disease. The study aims to evaluate whether these biomarkers can be used for periodontal diagnosis or prognosis.
The questions answered by the study are as follows:
Do asprosin, IL-39, IL-40 and IL-1β biomarker levels differ between individuals with and without diabetes? Do these biomarker levels differ significantly between individuals with periodontitis and individuals who are healthy? Can these biomarkers be used in the early diagnosis or recording the progression of periodontal diseases?
Detailed description
The study is planned to be conducted with 176 individuals with and without periodontal disease between the ages of 18-80 who come to the Department of Periodontics of the Faculty of Dentistry of Necmettin Erbakan University for treatment. Those who sign the 'informed consent form' will be included in the study.
In the periodontal examination of each patient who applies to the periodontology clinic, routine radiographic and clinical evaluations are performed, and routine periodontal status records (periodontal pocket depths of the teeth, attachment losses, mobility levels, furcation defect degrees, bleeding index on probing, gingival index, plaque index, amount of keratinized gingiva, gingival recessions, body/mass index) are taken and archived before the start of the patients' treatments and after each planned treatment. In addition, the sociodemographic data and brushing habits of each patient who will participate in the study are recorded. Saliva samples will also be collected from patients prior to treatment. Individuals will be divided into groups according to their periodontal disease status:
- 44 periodontally healthy, systemically healthy individuals
- 44 periodontally healthy, type 2 diabetic individuals
- 44 periodontitis, systemically healthy individuals
- 44 periodontitis, type 2 diabetic individuals
A calibrated expert clinician will determine periodontal status according to the criteria of the 2017 World Workshop on Classification of Periodontal and Peri-Implant Diseases and Conditions based on radiographic and clinical examination. Patients will need to meet the criteria for Stage II and III, generalized, periodontitis to be included in the periodontitis groups.
Saliva samples will be collected before periodontal measurements are taken to prevent saliva from bleeding during probing. Participants will be asked not to brush their teeth at least one hour before the sample collection and to avoid any food, sugary gum, cosmetic products such as lipstick, and any medication that will not affect the salivary hormone measurements. A total of 5 2 ml samples, one for each marker, will be collected from each patient between 9:00 and 10:00 in the morning. The samples will be collected in plastic tubes with a glass funnel within five minutes after each participant rinses their mouth with water. The tubes will then be capped and the samples will be centrifuged at 1000 rpm for 10 minutes to remove cellular elements and plaque. The supernatant liquid will be pipetted without touching the sediment formed at the bottom of the tubes, placed in polypropylene Eppendorf tubes, and stored at -20°C until analysis.
Analysis of Saliva Samples Samples will be placed at +4°C to be thawed on the day of analysis. ELISA kits will be used to determine Asprosin, IL-39,IL-40, IL-38 and IL-1B levels according to the manufacturer's instructions (Elabscience Biotechnology Co. Ltd).
Statistical Analysis Statistical analysis will be performed using the Statistical Package for Social Sciences (SPSS) version 23 (IBM Corp., Armonk, NY).
Data will be expressed as mean and standard deviation. Data normality will be assessed using the Kolmogorov-Smirnov test. Differences between parameter means in intragroup comparisons of periodontally healthy and periodontitis groups will be assessed using the One-way ANOVA (Bonferroni post-hoc) test. Differences between parameter means between periodontally healthy and periodontitis groups will be assessed using the independent t test. Pearson correlation coefficients will be used to assess correlations between clinical and biochemical parameters. Areas under the curve (AUC) and receiver operating characteristic (ROC) curves will be used to examine the sensitivity and specificity of salivary biomarkers in distinguishing periodontitis from periodontal health. p<0.05 will be considered statistically significant.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Periodontally healthy, systemically healthy individual | Other | Diagnostic Test: Periodontal examination and saliva collectionBefore starting the treatment of the patients and after each planned treatment, routine periodontal status records (periodontal pocket depths of the teeth, attachment losses, mobility levels, furcation defect degrees, bleeding index on probing, gingival index, plaque index, amount of keratinized gingiva, gingival recession, body/mass index) are taken and archived. In addition, sociodemographic data and brushing habits of each patient participating in the study are recorded. Saliva samples will also be collected from the patients before the treatment. |
| periodontally healthy individuals with type 2 diabetes | Active comparator | Diagnostic Test: Periodontal examination and saliva collectionBefore starting the treatment of the patients and after each planned treatment, routine periodontal status records (periodontal pocket depths of the teeth, attachment losses, mobility levels, furcation defect degrees, bleeding index on probing, gingival index, plaque index, amount of keratinized gingiva, gingival recession, body/mass index) are taken and archived. In addition, sociodemographic data and brushing habits of each patient participating in the study are recorded. Saliva samples will also be collected from the patients before the treatment. |
| Systemically healthy individual with periodontitis | Active comparator | Diagnostic Test: Periodontal examination and saliva collectionBefore starting the treatment of the patients and after each planned treatment, routine periodontal status records (periodontal pocket depths of the teeth, attachment losses, mobility levels, furcation defect degrees, bleeding index on probing, gingival index, plaque index, amount of keratinized gingiva, gingival recession, body/mass index) are taken and archived. In addition, sociodemographic data and brushing habits of each patient participating in the study are recorded. Saliva samples will also be collected from the patients before the treatment. |
| Individual with periodontitis and type 2 diabetes | Active comparator | Diagnostic Test: Periodontal examination and saliva collectionBefore starting the treatment of the patients and after each planned treatment, routine periodontal status records (periodontal pocket depths of the teeth, attachment losses, mobility levels, furcation defect degrees, bleeding index on probing, gingival index, plaque index, amount of keratinized gingiva, gingival recession, body/mass index) are taken and archived. In addition, sociodemographic data and brushing habits of each patient participating in the study are recorded. Saliva samples will also be collected from the patients before the treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Having a periodontally healthy diagnosis in routine clinical and radiographic examinations Inclusion criteria for the periodontitis group
- Diagnosing periodontitis in routine clinical and radiographic examinations
Key exclusion criteria (1 listed)
- - Patients with any autoimmune disease (Rheumatoid arthritis, familial Mediterranean fever, ankylosing spondylitis, Behcet, psoriasis, etc.) - Those who smoke 10 or more cigarettes per day
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 |
|---|---|---|
| Periodontal examination and saliva collectionBefore the periodontal examination, saliva samples are collected from each patient participating in the study and periodontal measurements are made. | Diagnostic test | Individual with periodontitis and type 2 diabetes, Periodontally healthy, systemically healthy individual, Systemically healthy individual with periodontitis, periodontally healthy individuals with type 2 diabetes |
Primary outcome
measurement of preoperative periodontal parameters
Time frame: before collecting saliva
To determine the baseline condition, preoperative measurement of periodontal parameters (amount of keratinized tissue, papilla height, papilla width, probing pocket depth, amount of recession, tissue thickness) will be recorded in millimeters using a periodontal probe.
gingival index measurement
Time frame: before collecting saliva
The status of gingival health will be assessed using the Gingival Index (Loe and Silness, 1963). This measurement will be made to determine the degree of gingival inflammation and will be scored on a scale from 0 (healthy gingiva) to 3 (severe inflammation and bleeding). Unit of Measurement: 0-3 scale.
Plaque Index (PI) measurement
Time frame: before collecting saliva
The degree of plaque accumulation on the tooth surfaces will be assessed using the Plaque Index (Silness and Loe, 1964). The assessment will be made on a scale from 0 (no plaque) to 3 (entire tooth surface covered with plaque). This measurement will be used to objectively determine the degree of plaque formation.Unit of Measurement: 0-3 scale.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Background: PubMed 38217801Gul SNS, Eminoglu DO, Laloglu E, Aydin T, Dilsiz A. Salivary and serum asprosin hormone levels in the 2018 EFP/AAP classification of periodontitis stages and body mass index status: a case-control study. Clin Oral Investig. 2024 Jan 13;28(1):91. doi: 10.1007/s00784-024-05494-9.
- Derived from this study: PubMed 41530539Oruc AH, Babayigit O. Salivary asprosin, IL-39, IL-40, and IL-1beta levels in diabetic patients with periodontitis: A cross-sectional analysis. Clin Oral Investig. 2026 Jan 14;30(1):52. doi: 10.1007/s00784-026-06744-8.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periodontal examination and saliva collection in people with Diabetes Mellitus and Periodontal Disease, run by Necmettin Erbakan 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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 16 Dec 2024. 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 ayşe hümeyra o oruç (+90 0543 260 94 64, ayse61836@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of preoperative periodontal parameters (time frame: before collecting saliva). 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 NCT06735313, which also lists 2 linked publications.
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 16 Dec 2024.