PeriodontitisNCT07917936
IL-4 and IL-17 Responses to Periodontal Therapy in Patients With Type 2 Diabetes
An observational study of Periodontitis and Type 2 Diabetes Mellitus, run by Dicle University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluated the effects of non-surgical periodontal therapy on periodontal health and inflammatory markers in patients with periodontitis, with and without type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Periodontitis, Type 2 Diabetes Mellitus
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Aug 2017to 8 Oct 2018
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consisted of 45 patients with chronic periodontitis who attended the Department of Periodontology, Faculty of Dentistry, Dicle University, Türkiye. Participants were classified into three groups according to their type 2 diabetes status and glycemic control: systemically healthy patients with periodontitis (n=16), patients with well-controlled type 2 diabetes and periodontitis (n=15), and patients with poorly controlled type 2 diabetes and periodontitis (n=14). Eligible participants were older than 35 years, had at least 20 teeth, and had periodontal involvement affecting at least 30% of their teeth, with probing depth ≥5 mm and clinical attachment loss ≥2 mm. All participants received routine non-surgical periodontal treatment and were evaluated at baseline and three months after treatment.
Who may be able to join
- At least 20 teeth present in the oral cavity.
- Age older than 35 years.
- At least 30% of teeth affected, with periodontal probing depth ≥5 mm and clinical attachment loss ≥2 mm.
- Presence of type 2 diabetes mellitus or absence of any systemic disease.
Who cannot join
- Tobacco or alcohol use.
- Presence of any systemic disease other than type 2 diabetes mellitus.
- Use of antibiotics, anti-inflammatory drugs, or steroids within the previous 3 months.
- Use of vitamin, mineral, or antioxidant supplements within the previous 3 months.
- Periodontal treatment within the previous 6 months.
- Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Periodontal Therapy on Gingival Crevicular Fluid and Serum Oxidative Stress and Inflammatory Markers in Patients With Type 2 Diabetes and Chronic Periodontitis
This study evaluated the effects of non-surgical periodontal therapy on periodontal health and inflammatory markers in patients with periodontitis, with and without type 2 diabetes mellitus.
Participants were divided into three groups according to their diabetes status and glycemic control: patients without diabetes, patients with well-controlled type 2 diabetes, and patients with poorly controlled type 2 diabetes.
Read more
Periodontal clinical measurements and gingival crevicular fluid and blood samples were collected at baseline. Participants subsequently received non-surgical periodontal therapy. Clinical measurements and biological samples were collected again three months after treatment.
The study assessed changes in periodontal clinical parameters and inflammatory biomarkers, including interleukin-4 (IL-4) and interleukin-17 (IL-17), to investigate whether responses to periodontal treatment differed according to diabetes status and glycemic control.
- Conditions
- Periodontitis, Type 2 Diabetes Mellitus
- Medical subject headings
- Periodontitis, Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gingival Crevicular Fluid and Serum IL-4 Levels
IL-4 levels measured in gingival crevicular fluid and serum before and 3 months after non-surgical periodontal therapy in three groups classified by type 2 diabetes status and glycemic control.
Measured: Baseline and 3 months after periodontal therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start8 Aug 2017
- Primary completion9 May 2018
- Study completion8 Oct 2018
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dicle University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ela Tules Kadiroğlu, Dicle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917936
- Sponsor's protocol ID
- DICLE-IL4IL17-001
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Periodontal Therapy on Gingival Crevicular Fluid and Serum Oxidative Stress and Inflammatory Markers in Patients With Type 2 Diabetes and Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT07917936
- Acronym / sponsor ID
- DICLE-IL4IL17-001
- Conditions
- Periodontitis, Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Dicle UniversityUniversity, hospital or other
- Study start
- 8 Aug 2017 (actual)
- Primary completion
- 9 May 2018 (actual)
- Study completion
- 8 Oct 2018 (actual)
- First posted
- 5 Nov 2026 (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 evaluated the effects of non-surgical periodontal therapy on periodontal health and inflammatory markers in patients with periodontitis, with and without type 2 diabetes mellitus.
Participants were divided into three groups according to their diabetes status and glycemic control: patients without diabetes, patients with well-controlled type 2 diabetes, and patients with poorly controlled type 2 diabetes.
Periodontal clinical measurements and gingival crevicular fluid and blood samples were collected at baseline. Participants subsequently received non-surgical periodontal therapy. Clinical measurements and biological samples were collected again three months after treatment.
The study assessed changes in periodontal clinical parameters and inflammatory biomarkers, including interleukin-4 (IL-4) and interleukin-17 (IL-17), to investigate whether responses to periodontal treatment differed according to diabetes status and glycemic control.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of 45 patients with chronic periodontitis who attended the Department of Periodontology, Faculty of Dentistry, Dicle University, Türkiye. Participants were classified into three groups according to their type 2 diabetes status and glycemic control: systemically healthy patients with periodontitis (n=16), patients with well-controlled type 2 diabetes and periodontitis (n=15), and patients with poorly controlled type 2 diabetes and periodontitis (n=14). Eligible participants were older than 35 years, had at least 20 teeth, and had periodontal involvement affecting at least 30% of their teeth, with probing depth ≥5 mm and clinical attachment loss ≥2 mm. All participants received routine non-surgical periodontal treatment and were evaluated at baseline and three months after treatment.
Key inclusion criteria (4 listed)
- At least 20 teeth present in the oral cavity.
- Age older than 35 years.
- At least 30% of teeth affected, with periodontal probing depth ≥5 mm and clinical attachment loss ≥2 mm.
- Presence of type 2 diabetes mellitus or absence of any systemic disease.
Key exclusion criteria (6 listed)
- Tobacco or alcohol use.
- Presence of any systemic disease other than type 2 diabetes mellitus.
- Use of antibiotics, anti-inflammatory drugs, or steroids within the previous 3 months.
- Use of vitamin, mineral, or antioxidant supplements within the previous 3 months.
- Periodontal treatment within the previous 6 months.
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
Change in Gingival Crevicular Fluid and Serum IL-4 Levels
Time frame: Baseline and 3 months after periodontal therapy
IL-4 levels measured in gingival crevicular fluid and serum before and 3 months after non-surgical periodontal therapy in three groups classified by type 2 diabetes status and glycemic control.
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 5 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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 and Type 2 Diabetes Mellitus, run by Dicle 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 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: finished, as of the sponsor's last update on 5 Nov 2026. 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?
Change in Gingival Crevicular Fluid and Serum IL-4 Levels (time frame: Baseline and 3 months after periodontal therapy). 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 5 Nov 2026.