Periodontitis, Diabetes Mellitus Type 2NCT06516328
AGE/sRAGE Ratio in Diabetic Periodontitis
An observational study of Periodontitis, Diabetes Mellitus Type 2, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to learn about some molecules in the disease mechanism of type 2 diabetes and periodontitis. There are end products inside the body called AGEs and their receptors binding to them especially (sRAGE, RAGE) in people with diabetes in hyperglycemic state.These molecules are… Read more about this study
- Who is it for?
- Ages 25 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Diabetes Mellitus Type 2
- What is being tested?
- Observational
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 10 Dec 2023
- 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 25 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consisted of participants who applied to Hacettepe University Department of Periodontology and Hacettepe University Department of Endocrinology and Metabolism. Patients who agreed to participate in the study gave their written informed consent were included.
Who may be able to join
- Having interdental attachment loss in at least two non-adjacent teeth, or with >3 mm of attachment loss in the buccal or palatal/lingual region with >3 mm probing depth in at least two teeth for periodontitis groups.
- Having minimum 5mm or more pocket depth in at least 6 periodontal pockets.
- HbA1c value ≤ 6.5% and fasting blood sugar levels <200 mg/dl for the controlled diabetes group.
- HbA1c value > 6.5% and fasting blood sugar levels > 200 mg/dl for uncontrolled diabetes group.
Who cannot join
- having periodontal treatment in the last six months;
- participants with smoking habit or history; and
- usage of medicine that may affect study results (mouthwash, antibiotics, corticosteroid, statins etc.) three months before collecting dental plaque and GCF samples.
- Lactating or pregnant patients
- Patients with systemic diseases other than type 2 diabetes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AGE/sRAGE and IL-17 Levels in Type 2 Diabetic Periodontitis Patients
The goal of this observational study is to learn about some molecules in the disease mechanism of type 2 diabetes and periodontitis. There are end products inside the body called AGEs and their receptors binding to them especially (sRAGE, RAGE) in people with diabetes in hyperglycemic state.These molecules are important also in periodontitis (the disease of teeth that may end with exfoliation of the tooth). Diabetes and periodontitis enhance each other's disease-causing effects. Both is chronic inflammatory diseases and IL-17 is another molecule having role in this process.
Totally 64 men and women aged between 27-60 included in the study. Study groups were : 1.participants with healthy teeth and no diabetes, 2. participants with periodontitis without diabetes, 3.participants with periodontitis and controlled diabetes, 4.participants with periodontitis and uncontrolled diabetes (6.5% and fasting blood sugar levels <200 mg/dl). Researchers got saliva and gingival crevicular fluid (GCF) samples from diseased teeth and examined AGE, sRAGE, IL-17 levels. GCF is a fluid around the crevice of the theeth with different characteristics from saliva.
As a result AGE/sRAGE ratio and IL-17 levels of diseased groups were higher than healthy group, while sRAGE levels were significantly lower in GCF samples. Researchers concluded that GCF and saliva AGE/sRAGE ratio may represent as a biomarker in periodontitis patients with uncontrolled diabetes.
- Conditions
- Periodontitis, Diabetes Mellitus Type 2
- Being tested
- Observational
- Medical subject headings
- Periodontitis, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
GCF and saliva samples obtained.
| Study group | Role | What they receive |
|---|---|---|
| healthy (H) | Periodontally and systemically healthy individuals Receives: Other: Observational | |
| Periodontitis (P) | Patients with periodontitis without diabetes Receives: Other: Observational | |
| Diabetic Periodontitis (DP) group | Periodontitis patients with diabetes under control (Glycosylated hemoglobin (HbA1c) value ≤ 6.5% and fasting blood sugar levels <200 mg/dl.) Receives: Other: Observational | |
| Poorly controlled Diabetic Periodontitis group (PDP) | Periodontitis patients with uncontrolled diabetes HbA1c value > 6.5% and fasting blood sugar levels > 200 mg/dl. Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
AGEs/RAGE ratio, IL-17 level in GCF and saliva
AGEs to RAGE ratio comparison between study groups
Measured: 3 to 6 months
AGEs/RAGE ratio, IL-17 level in GCF and saliva
IL-17 level comparison between study groups
Measured: 3 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start1 May 2022
- Primary completion28 Nov 2023
- Study completion10 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis, Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yagmur Deniz YILDIRIM, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516328
- Sponsor's protocol ID
- GO23/63
- Status last verified
- Jul 2024
- First submitted
- 14 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AGE/sRAGE and IL-17 Levels in Type 2 Diabetic Periodontitis Patients
- ClinicalTrials.gov ID
- NCT06516328
- Acronym / sponsor ID
- GO23/63
- Conditions
- Periodontitis, Diabetes Mellitus Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 28 Nov 2023 (actual)
- Study completion
- 10 Dec 2023 (actual)
- First posted
- 23 Jul 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 goal of this observational study is to learn about some molecules in the disease mechanism of type 2 diabetes and periodontitis. There are end products inside the body called AGEs and their receptors binding to them especially (sRAGE, RAGE) in people with diabetes in hyperglycemic state.These molecules are important also in periodontitis (the disease of teeth that may end with exfoliation of the tooth). Diabetes and periodontitis enhance each other's disease-causing effects. Both is chronic inflammatory diseases and IL-17 is another molecule having role in this process.
Totally 64 men and women aged between 27-60 included in the study. Study groups were : 1.participants with healthy teeth and no diabetes, 2. participants with periodontitis without diabetes, 3.participants with periodontitis and controlled diabetes, 4.participants with periodontitis and uncontrolled diabetes (6.5% and fasting blood sugar levels <200 mg/dl). Researchers got saliva and gingival crevicular fluid (GCF) samples from diseased teeth and examined AGE, sRAGE, IL-17 levels. GCF is a fluid around the crevice of the theeth with different characteristics from saliva.
As a result AGE/sRAGE ratio and IL-17 levels of diseased groups were higher than healthy group, while sRAGE levels were significantly lower in GCF samples. Researchers concluded that GCF and saliva AGE/sRAGE ratio may represent as a biomarker in periodontitis patients with uncontrolled diabetes.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| healthy (H) | – | Other: ObservationalPeriodontally and systemically healthy individuals |
| Periodontitis (P) | – | Other: ObservationalPatients with periodontitis without diabetes |
| Diabetic Periodontitis (DP) group | – | Other: ObservationalPeriodontitis patients with diabetes under control (Glycosylated hemoglobin (HbA1c) value ≤ 6.5% and fasting blood sugar levels <200 mg/dl.) |
| Poorly controlled Diabetic Periodontitis group (PDP) | – | Other: ObservationalPeriodontitis patients with uncontrolled diabetes HbA1c value > 6.5% and fasting blood sugar levels > 200 mg/dl. |
Who may qualify
- Ages
- 25 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of participants who applied to Hacettepe University Department of Periodontology and Hacettepe University Department of Endocrinology and Metabolism. Patients who agreed to participate in the study gave their written informed consent were included.
Key inclusion criteria (4 listed)
- Having interdental attachment loss in at least two non-adjacent teeth, or with >3 mm of attachment loss in the buccal or palatal/lingual region with >3 mm probing depth in at least two teeth for periodontitis groups.
- Having minimum 5mm or more pocket depth in at least 6 periodontal pockets.
- HbA1c value ≤ 6.5% and fasting blood sugar levels <200 mg/dl for the controlled diabetes group.
- HbA1c value > 6.5% and fasting blood sugar levels > 200 mg/dl for uncontrolled diabetes group.
Key exclusion criteria (5 listed)
- having periodontal treatment in the last six months;
- participants with smoking habit or history; and
- usage of medicine that may affect study results (mouthwash, antibiotics, corticosteroid, statins etc.) three months before collecting dental plaque and GCF samples.
- Lactating or pregnant patients
- Patients with systemic diseases other than type 2 diabetes.
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 |
|---|---|---|
| ObservationalGCF and saliva samples obtained. | Other | Diabetic Periodontitis (DP) group, Periodontitis (P), Poorly controlled Diabetic Periodontitis group (PDP), healthy (H) |
Primary outcome
AGEs/RAGE ratio, IL-17 level in GCF and saliva
Time frame: 3 to 6 months
AGEs to RAGE ratio comparison between study groups
AGEs/RAGE ratio, IL-17 level in GCF and saliva
Time frame: 3 to 6 months
IL-17 level comparison between study groups
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 23 Jul 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, Diabetes Mellitus Type 2, run by Hacettepe 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 5 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 23 Jul 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?
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?
AGEs/RAGE ratio, IL-17 level in GCF and saliva (time frame: 3 to 6 months). The study lists 2 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 23 Jul 2024.