PeriodontitisNCT06803836
Inflammatory Response and Gingival iNOS Levels in Diabetic vs. Non-Diabetic Periodontitis Patients
An observational study of Periodontitis and Type 2 Diabetes, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
This study investigates the relationship between Type 2 diabetes mellitus (T2DM), glycemic control, and periodontal disease. Researchers analyzed the levels of inducible nitric oxide synthase (iNOS) and proinflammatory cytokines, such as tumor necrosis factor-alpha (TNF-α), interleukin-1 beta (IL-1β), and… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Type 2 Diabetes, Glycemic Control
- How many people
- 118 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2020to 10 Mar 2022
- 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: Study participants will be selected from individuals seeking dental care at the Department of Periodontology, Faculty of Dentistry, Ondokuz Mayis University, Samsun, Turkey. The population includes adults with varying systemic and periodontal health statuses, such as individuals with Type 2 diabetes mellitus (T2DM) and/or periodontitis. Participants represent a diverse clinical population from the surrounding region and are recruited based on their suitability for the study's objectives.
Who may be able to join
- Participants must be between 18 and 65 years of age (according to the World Health Organization definition of young and adult individuals).
- Diagnosed with periodontitis (Stage 2, 3, or 4) based on the 2017 Classification of Periodontal Diseases and Conditions.
- Diabetes control status determined by HbA1c levels: controlled diabetes: HbA1c ≤ 7, uncontrolled diabetes: HbA1c > 7
- Must volunteer and sign an informed consent form for clinical evaluations and collection of tissue samples.
Who cannot join
- History of smoking.
- Presence of systemic or local diseases affecting the immune system (e.g., autoimmune disorders, HIV, hepatitis).
- Pregnant or breastfeeding individuals.
- History of antibiotic use or periodontal treatment within the last 3-6 months.
- History of immunosuppressive therapy or chemotherapy.
- Requirement for antibiotic prophylaxis.
- Severe systemic illnesses unrelated to diabetes (e.g., cancer, cardiovascular diseases).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Periodontology, Faculty of Dentistry, Ondokuz Mayis University,
Samsun, 55200
About this study
Official title: Inducible Nitric Oxide Synthase and Proinflammatory Cytokines in Periodontal Disease: Impact of Glycemic Control in T2DM
This study investigates the relationship between Type 2 diabetes mellitus (T2DM), glycemic control, and periodontal disease. Researchers analyzed the levels of inducible nitric oxide synthase (iNOS) and proinflammatory cytokines, such as tumor necrosis factor-alpha (TNF-α), interleukin-1 beta (IL-1β), and interferon-gamma (IFN-γ), in 118 participants. The participants were categorized based on their periodontal and diabetes control status.
Read the detailed description
This study is an observational analysis using a cross-sectional time perspective and explores the interplay between Type 2 diabetes mellitus (T2DM), glycemic control, and periodontal disease by evaluating the expression of inducible nitric oxide synthase (iNOS) and proinflammatory mediators (TNF-α, IL-1β, IFN-γ, and PGE2) in gingival tissues. A total of 118 participants were classified into six groups based on their periodontal health and glycemic control status, determined by HbA1c levels.
Gingival biopsies were collected and analyzed using ELISA to measure biomarker levels. The study found significant differences in inflammatory marker concentrations between groups, with poorly controlled T2DM participants showing markedly higher levels of iNOS and cytokines. This aligns with the hypothesis that poor glycemic control amplifies periodontal inflammation and oxidative stress, contributing to tissue destruction.
The findings underline the critical role of glycemic regulation in managing periodontal disease and suggest potential targets, such as iNOS, for therapeutic interventions. This study adheres to ethical standards, including informed consent and approval by the Ondokuz Mayis University Clinical Research Ethics Committee. The results emphasize the bidirectional relationship between diabetes and periodontal health, contributing to a better understanding of the systemic implications of periodontal inflammation.
- Conditions
- Periodontitis, Type 2 Diabetes, Glycemic Control
- Keywords
- periodontitis, diabetes, iNOS, glycemic control
- Medical subject headings
- Periodontitis, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Systemically Healthy Participants with Periodontitis | This group includes participants with periodontitis but without any systemic conditions such as diabetes. Periodontitis diagnosis is based on clinical attachment loss (CAL) and probing depth (PD) criteria. | |
| Systemically and Periodontally Healthy Participants | This group includes systemically and periodontally healthy participants. They serve as a control group to compare inflammatory biomarker levels under healthy conditions. | |
| Uncontrolled T2DM Participants with Periodontitis | Participants in this group have Type 2 diabetes mellitus (T2DM) with HbA1c levels >7 (uncontrolled diabetes) and periodontitis. Periodontal and systemic conditions were assessed. | |
| Controlled T2DM Participants with Periodontitis | This group includes participants with T2DM whose diabetes is well-controlled (HbA1c ≤7) and who have periodontitis. Clinical evaluations were performed. | |
| Controlled T2DM Periodontally Healthy Participants | Participants in this group have controlled T2DM (HbA1c ≤7) but no periodontal disease. They serve as a control group for comparing biomarker levels under controlled glycemic conditions. | |
| Uncontrolled T2DM Periodontally Healthy Participants | This group includes participants with uncontrolled T2DM (HbA1c >7) but no periodontal disease. Biomarker levels were measured to evaluate the effects of poor glycemic control on otherwise healthy periodontal tissues. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inducible Nitric Oxide Synthase (iNOS) concentration in gingival tissues
iNOS levels will be measured in gingival tissue biopsies collected from all participants using ELISA. The aim is to assess the differences in iNOS expression across groups with varying periodontal and glycemic control statuses.
Measured: At baseline (single time point)
Secondary outcomes (3)
Concentration of proinflammatory cytokines (e.g., TNF-α, IL-1β, IFN-γ, and PGE2)
The levels of cytokines will be analyzed in gingival tissue samples to investigate their relationship with iNOS expression and differences between study groups.
Measured: At baseline (single time point)
Correlation between glycemic control (HbA1c levels) and iNOS/cytokine levels
The study will examine the relationship between glycemic control (as determined by HbA1c levels) and biomarkers to evaluate the impact of diabetes control on periodontal inflammation.
Measured: At baseline (single time point)
Periodontal clinical parameters (e.g., probing depth, clinical attachment level)
Clinical periodontal measurements, such as probing depth (PD) and clinical attachment level (CAL), will be recorded to assess the severity of periodontal disease in each group.
Measured: At baseline (single time point)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start10 Jan 2020
- Primary completion10 Jan 2022
- Study completion10 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sude Yildirim, Ondokuz Mayıs University
- Investigators
- Sude YILDIRIM BOLAT, DDS, Principal investigator, Ondokuz Mayıs University, Department of Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06803836
- Sponsor's protocol ID
- DHF.061
- Status last verified
- Jan 2025
- First submitted
- 27 Jan 2025
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The decision to not share individual participant data (IPD) is based on ethical considerations, institutional policies, and the need to protect participant privacy and confidentiality. The collected data will only be used for the purposes of this study and will not be made available for external use.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inducible Nitric Oxide Synthase and Proinflammatory Cytokines in Periodontal Disease: Impact of Glycemic Control in T2DM
- ClinicalTrials.gov ID
- NCT06803836
- Acronym / sponsor ID
- DHF.061
- Conditions
- Periodontitis, Type 2 Diabetes, Glycemic Control
- Keywords
- periodontitis, diabetes, iNOS, glycemic control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- 10 Mar 2022 (actual)
- First posted
- 31 Jan 2025 (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.
This study investigates the relationship between Type 2 diabetes mellitus (T2DM), glycemic control, and periodontal disease. Researchers analyzed the levels of inducible nitric oxide synthase (iNOS) and proinflammatory cytokines, such as tumor necrosis factor-alpha (TNF-α), interleukin-1 beta (IL-1β), and interferon-gamma (IFN-γ), in 118 participants. The participants were categorized based on their periodontal and diabetes control status.
Detailed description
This study is an observational analysis using a cross-sectional time perspective and explores the interplay between Type 2 diabetes mellitus (T2DM), glycemic control, and periodontal disease by evaluating the expression of inducible nitric oxide synthase (iNOS) and proinflammatory mediators (TNF-α, IL-1β, IFN-γ, and PGE2) in gingival tissues. A total of 118 participants were classified into six groups based on their periodontal health and glycemic control status, determined by HbA1c levels.
Gingival biopsies were collected and analyzed using ELISA to measure biomarker levels. The study found significant differences in inflammatory marker concentrations between groups, with poorly controlled T2DM participants showing markedly higher levels of iNOS and cytokines. This aligns with the hypothesis that poor glycemic control amplifies periodontal inflammation and oxidative stress, contributing to tissue destruction.
The findings underline the critical role of glycemic regulation in managing periodontal disease and suggest potential targets, such as iNOS, for therapeutic interventions. This study adheres to ethical standards, including informed consent and approval by the Ondokuz Mayis University Clinical Research Ethics Committee. The results emphasize the bidirectional relationship between diabetes and periodontal health, contributing to a better understanding of the systemic implications of periodontal inflammation.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Systemically Healthy Participants with Periodontitis | – | –This group includes participants with periodontitis but without any systemic conditions such as diabetes. Periodontitis diagnosis is based on clinical attachment loss (CAL) and probing depth (PD) criteria. |
| Systemically and Periodontally Healthy Participants | – | –This group includes systemically and periodontally healthy participants. They serve as a control group to compare inflammatory biomarker levels under healthy conditions. |
| Uncontrolled T2DM Participants with Periodontitis | – | –Participants in this group have Type 2 diabetes mellitus (T2DM) with HbA1c levels >7 (uncontrolled diabetes) and periodontitis. Periodontal and systemic conditions were assessed. |
| Controlled T2DM Participants with Periodontitis | – | –This group includes participants with T2DM whose diabetes is well-controlled (HbA1c ≤7) and who have periodontitis. Clinical evaluations were performed. |
| Controlled T2DM Periodontally Healthy Participants | – | –Participants in this group have controlled T2DM (HbA1c ≤7) but no periodontal disease. They serve as a control group for comparing biomarker levels under controlled glycemic conditions. |
| Uncontrolled T2DM Periodontally Healthy Participants | – | –This group includes participants with uncontrolled T2DM (HbA1c >7) but no periodontal disease. Biomarker levels were measured to evaluate the effects of poor glycemic control on otherwise healthy periodontal tissues. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be selected from individuals seeking dental care at the Department of Periodontology, Faculty of Dentistry, Ondokuz Mayis University, Samsun, Turkey. The population includes adults with varying systemic and periodontal health statuses, such as individuals with Type 2 diabetes mellitus (T2DM) and/or periodontitis. Participants represent a diverse clinical population from the surrounding region and are recruited based on their suitability for the study's objectives.
Key inclusion criteria (4 listed)
- Participants must be between 18 and 65 years of age (according to the World Health Organization definition of young and adult individuals).
- Diagnosed with periodontitis (Stage 2, 3, or 4) based on the 2017 Classification of Periodontal Diseases and Conditions.
- Diabetes control status determined by HbA1c levels: controlled diabetes: HbA1c ≤ 7, uncontrolled diabetes: HbA1c > 7
- Must volunteer and sign an informed consent form for clinical evaluations and collection of tissue samples.
Key exclusion criteria (7 listed)
- History of smoking.
- Presence of systemic or local diseases affecting the immune system (e.g., autoimmune disorders, HIV, hepatitis).
- Pregnant or breastfeeding individuals.
- History of antibiotic use or periodontal treatment within the last 3-6 months.
- History of immunosuppressive therapy or chemotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inducible Nitric Oxide Synthase (iNOS) concentration in gingival tissues
Time frame: At baseline (single time point)
iNOS levels will be measured in gingival tissue biopsies collected from all participants using ELISA. The aim is to assess the differences in iNOS expression across groups with varying periodontal and glycemic control statuses.
3 secondary outcomes
Concentration of proinflammatory cytokines (e.g., TNF-α, IL-1β, IFN-γ, and PGE2)
Time frame: At baseline (single time point)
Correlation between glycemic control (HbA1c levels) and iNOS/cytokine levels
Time frame: At baseline (single time point)
Periodontal clinical parameters (e.g., probing depth, clinical attachment level)
Time frame: At baseline (single time point)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Individual participant dataSharing planned: No. The decision to not share individual participant data (IPD) is based on ethical considerations, institutional policies, and the need to protect participant privacy and confidentiality. The collected data will only be used for the purposes of this study and will not be made available for external use.
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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.
Sude YILDIRIM BOLAT, DDS principal investigator
Ondokuz Mayıs University, Department of Periodontology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis and Type 2 Diabetes, run by Ondokuz Mayıs 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 4 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 4 Feb 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?
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?
Inducible Nitric Oxide Synthase (iNOS) concentration in gingival tissues (time frame: At baseline (single time point)). 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 4 Feb 2025; AzTrials last refreshed its copy on 6 Nov 2026.