ObesityNCT07287553
Dietary Inflammatory Index and Periodontal Status in Obese Patients
An observational study of Obesity, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study aimed to investigate the effect of nutrition on periodontal status in individuals diagnosed with obesity and without any other systemic disease, and to investigate the relationship between DII and periodontal disease risk. A total of 200 participants will be included in the study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Periodontal indices will be obtained and serum and crevicular fluid samples will be collected
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Nov 2025to 3 Jun 2026
- 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
- Adult, Older adult
Study population: Recep Tayyip Erdoğan University
Who may be able to join
- Being diagnosed with obesity,
- Not having any systemic conditions other than obesity (systemic diseases that may affect periodontal health, such as cardiovascular disease, chronic kidney disease, Type 1 diabetes, Type 2 diabetes, and hypertension (>130/85 mmHg)),
- Being between the ages of 18 and 65,
- Not smoking or consuming alcohol,
- Not having used anti-inflammatory medications in the last 3 months, or antibiotics or systemic corticosteroids in the last 6 months,
- Not being pregnant or lactating,
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- Not having received periodontal treatment in the last 6 months,
- Not having received nutritional advice in the last 3 months,
- Obesity diagnosis: BMI > 30 kg/m2 or waist circumference: > 100 cm for men and > 90 cm for women.
Who cannot join
- Non-obese
- Having any systemic disease other than obesity (such as cardiovascular disease, chronic kidney disease, Type 1 diabetes, Type 2 diabetes, and hypertension (>130/85 mmHg) that may affect periodontal health)
- Being over 65 years old and under 18 years old
- Smoking and alcohol use
- Having used anti-inflammatory drugs in the last 3 months, antibiotics, or systemic corticosteroids in the last 6 months
- Being pregnant or lactating
- Having received periodontal treatment in the last 6 months
- Having received nutritional advice in the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Dietary Inflammatory Index and Periodontal Status in Obese Patients
In this study aimed to investigate the effect of nutrition on periodontal status in individuals diagnosed with obesity and without any other systemic disease, and to investigate the relationship between DII and periodontal disease risk. A total of 200 participants will be included in the study. Participants' overall daily Dietary Inflammatory Index (DII) scores will be calculated. The obtained scores will be divided into four groups, from low to high: Q1 (n=50), Q2 (n=50), Q3 (n=50), and Q4 (n=50). According to the DII, groups Q1 and Q2, which include lower scores, represent individuals on an anti-inflammatory diet, while groups Q3 and Q4, which include higher scores, represent individuals on a pro-inflammatory diet. Interleukin (IL)-1β, IL-10, total oxidant status (TOS), and total antioxidant status (TAS) were collected from gingival crevicular fluid (GCF) and serum samples. The levels of biomarkers such as malondialdehyde (MDA), glutathione (GSH), leptin, adiponectin, tumor necrosis factor (TNF)-α and C-reactive protein (CRP) from serum samples alone will be analyzed by ELISA method at the Recep Tayyip Erdoğan University Medical Biochemistry Laboratory.
- Conditions
- Obesity
- Being tested
- Periodontal indices will be obtained, serum and crevicular fluid samples will be collected
- Keywords
- obesity, periodontal status, dietary inflammatory index
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal indices will be obtainedOther
Periodontal indices will be obtained from all participants
serum and crevicular fluid samples will be collectedOther
Serum and gingival crevicular fluid samples will be collected from all participants.
| Study group | Role | What they receive |
|---|---|---|
| anti-inflammatory diet group 1 | Individuals on an anti-inflammatory diet Receives: Other: Periodontal indices will be obtained; Other: serum and crevicular fluid samples will be collected | |
| anti-inflammatory diet group 2 | Individuals on an anti-inflammatory diet Receives: Other: Periodontal indices will be obtained; Other: serum and crevicular fluid samples will be collected | |
| pro-inflammatory diet group 1 | individuals on a pro-inflammatory diet Receives: Other: Periodontal indices will be obtained; Other: serum and crevicular fluid samples will be collected | |
| pro-inflammatory diet group 2 | individuals on a pro-inflammatory diet Receives: Other: Periodontal indices will be obtained; Other: serum and crevicular fluid samples will be collected |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal pocket depth
The distance between the pocket base and the gingival margin will be measured. It will be measured from the six surfaces of each tooth and the average will be taken higher scores indicate worse outcome.
Measured: baseline
Clinical attachment loss
It will be calculated by measuring the distance between the cementoenemal border and the pocket base. It will be measured from the six surfaces of each tooth and the average will be taken higher scores indicate worse outcome.
Measured: baseline
Secondary outcomes (10)
interleukin (IL)-1β level
IL-1β levels will be measured with biochemical kits.
Measured: baseline
interleukin (IL)-10 level
IL-10 levels will be measured with biochemical kits.
Measured: baseline
total oxidant status (TOS) level
TOS levels will be measured with biochemical kits.
Measured: baseline
total antioxidant status (TAS) level
TAS levels will be measured with biochemical kits.
Measured: baseline
serum leptin level
Leptin levels in serum will be measured with biochemical kits.
Measured: baseline
serum tumor necrosis factor (TNF)-α level
TNF-α levels in serum will be measured with biochemical kits.
Measured: baseline
serum adiponectin level
Adiponectin levels in serum will be measured with biochemical kits.
Measured: baseline
serum C-reactive protein (CRP) level
CRP levels in serum will be measured with biochemical kits.
Measured: baseline
serum malondialdehyde (MDA) level
MDA levels in serum will be measured with biochemical kits.
Measured: baseline
serum glutathione (GSH) level
GSH levels in serum will be measured with biochemical kits.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start22 Nov 2025
- Primary completion3 Jun 2026
- Study completion3 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Yemenoğlu, Recep Tayyip Erdogan University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287553
- Sponsor's protocol ID
- RecepTayyip ErdoganUniversity
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 5 Jun 2026
- 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 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Dietary Inflammatory Index and Periodontal Status in Obese Patients
- ClinicalTrials.gov ID
- NCT07287553
- Acronym / sponsor ID
- RecepTayyip ErdoganUniversity
- Conditions
- Obesity
- Keywords
- obesity, periodontal status, dietary inflammatory index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 22 Nov 2025 (actual)
- Primary completion
- 3 Jun 2026 (actual)
- Study completion
- 3 Jun 2026 (actual)
- First posted
- 17 Dec 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.
In this study aimed to investigate the effect of nutrition on periodontal status in individuals diagnosed with obesity and without any other systemic disease, and to investigate the relationship between DII and periodontal disease risk. A total of 200 participants will be included in the study. Participants' overall daily Dietary Inflammatory Index (DII) scores will be calculated. The obtained scores will be divided into four groups, from low to high: Q1 (n=50), Q2 (n=50), Q3 (n=50), and Q4 (n=50). According to the DII, groups Q1 and Q2, which include lower scores, represent individuals on an anti-inflammatory diet, while groups Q3 and Q4, which include higher scores, represent individuals on a pro-inflammatory diet. Interleukin (IL)-1β, IL-10, total oxidant status (TOS), and total antioxidant status (TAS) were collected from gingival crevicular fluid (GCF) and serum samples. The levels of biomarkers such as malondialdehyde (MDA), glutathione (GSH), leptin, adiponectin, tumor necrosis factor (TNF)-α and C-reactive protein (CRP) from serum samples alone will be analyzed by ELISA method at the Recep Tayyip Erdoğan University Medical Biochemistry Laboratory.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| anti-inflammatory diet group 1 | – | Other: Periodontal indices will be obtained, Other: serum and crevicular fluid samples will be collectedIndividuals on an anti-inflammatory diet |
| anti-inflammatory diet group 2 | – | Other: Periodontal indices will be obtained, Other: serum and crevicular fluid samples will be collectedIndividuals on an anti-inflammatory diet |
| pro-inflammatory diet group 1 | – | Other: Periodontal indices will be obtained, Other: serum and crevicular fluid samples will be collectedindividuals on a pro-inflammatory diet |
| pro-inflammatory diet group 2 | – | Other: Periodontal indices will be obtained, Other: serum and crevicular fluid samples will be collectedindividuals on a pro-inflammatory diet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Recep Tayyip Erdoğan University
Key inclusion criteria (9 listed)
- Being diagnosed with obesity,
- Not having any systemic conditions other than obesity (systemic diseases that may affect periodontal health, such as cardiovascular disease, chronic kidney disease, Type 1 diabetes, Type 2 diabetes, and hypertension (>130/85 mmHg)),
- Being between the ages of 18 and 65,
- Not smoking or consuming alcohol,
- Not having used anti-inflammatory medications in the last 3 months, or antibiotics or systemic corticosteroids in the last 6 months,
Key exclusion criteria (8 listed)
- Non-obese
- Having any systemic disease other than obesity (such as cardiovascular disease, chronic kidney disease, Type 1 diabetes, Type 2 diabetes, and hypertension (>130/85 mmHg) that may affect periodontal health)
- Being over 65 years old and under 18 years old
- Smoking and alcohol use
- Having used anti-inflammatory drugs in the last 3 months, antibiotics, or systemic corticosteroids in the last 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periodontal indices will be obtainedPeriodontal indices will be obtained from all participants | Other | anti-inflammatory diet group 1, anti-inflammatory diet group 2, pro-inflammatory diet group 1, pro-inflammatory diet group 2 |
| serum and crevicular fluid samples will be collectedSerum and gingival crevicular fluid samples will be collected from all participants. | Other | anti-inflammatory diet group 1, anti-inflammatory diet group 2, pro-inflammatory diet group 1, pro-inflammatory diet group 2 |
Primary outcome
Periodontal pocket depth
Time frame: baseline
The distance between the pocket base and the gingival margin will be measured. It will be measured from the six surfaces of each tooth and the average will be taken higher scores indicate worse outcome.
Clinical attachment loss
Time frame: baseline
It will be calculated by measuring the distance between the cementoenemal border and the pocket base. It will be measured from the six surfaces of each tooth and the average will be taken higher scores indicate worse outcome.
10 secondary outcomes
interleukin (IL)-1β level
Time frame: baseline
interleukin (IL)-10 level
Time frame: baseline
total oxidant status (TOS) level
Time frame: baseline
total antioxidant status (TAS) level
Time frame: baseline
serum leptin level
Time frame: baseline
serum tumor necrosis factor (TNF)-α level
Time frame: baseline
serum adiponectin level
Time frame: baseline
serum C-reactive protein (CRP) level
Time frame: baseline
serum malondialdehyde (MDA) level
Time frame: baseline
serum glutathione (GSH) level
Time frame: baseline
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 Jun 2026.
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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 Obesity, run by Recep Tayyip Erdogan University Training and Research Hospital 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 9 inclusion and 8 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 Jun 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?
Periodontal pocket depth (time frame: baseline). 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 5 Jun 2026.