Dietary Inflammatory Index and Periodontal Status in Obese Patients

June 3, 2026 updated by: Hatice Yemenoğlu, Recep Tayyip Erdogan University Training and Research Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Recep Tayyip Erdoğan University

Description

Inclusion Criteria:

  • 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,
  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
anti-inflammatory diet group 1
Individuals on an anti-inflammatory diet
Other: Periodontal indices will be obtained
Periodontal indices will be obtained from all participants
Other: serum and crevicular fluid samples will be collected
Serum and gingival crevicular fluid samples will be collected from all participants.
anti-inflammatory diet group 2
Individuals on an anti-inflammatory diet
Other: Periodontal indices will be obtained
Periodontal indices will be obtained from all participants
Other: serum and crevicular fluid samples will be collected
Serum and gingival crevicular fluid samples will be collected from all participants.
pro-inflammatory diet group 1
individuals on a pro-inflammatory diet
Other: Periodontal indices will be obtained
Periodontal indices will be obtained from all participants
Other: serum and crevicular fluid samples will be collected
Serum and gingival crevicular fluid samples will be collected from all participants.
pro-inflammatory diet group 2
individuals on a pro-inflammatory diet
Other: Periodontal indices will be obtained
Periodontal indices will be obtained from all participants
Other: serum and crevicular fluid samples will be collected
Serum and gingival crevicular fluid samples will be collected from all participants.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
baseline
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.
baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
interleukin (IL)-1β level
Time Frame: baseline
IL-1β levels will be measured with biochemical kits.
baseline
interleukin (IL)-10 level
Time Frame: baseline
IL-10 levels will be measured with biochemical kits.
baseline
total oxidant status (TOS) level
Time Frame: baseline
TOS levels will be measured with biochemical kits.
baseline
total antioxidant status (TAS) level
Time Frame: baseline
TAS levels will be measured with biochemical kits.
baseline
serum leptin level
Time Frame: baseline
Leptin levels in serum will be measured with biochemical kits.
baseline
serum tumor necrosis factor (TNF)-α level
Time Frame: baseline
TNF-α levels in serum will be measured with biochemical kits.
baseline
serum adiponectin level
Time Frame: baseline
Adiponectin levels in serum will be measured with biochemical kits.
baseline
serum C-reactive protein (CRP) level
Time Frame: baseline
CRP levels in serum will be measured with biochemical kits.
baseline
serum malondialdehyde (MDA) level
Time Frame: baseline
MDA levels in serum will be measured with biochemical kits.
baseline
serum glutathione (GSH) level
Time Frame: baseline
GSH levels in serum will be measured with biochemical kits.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Recep Tayyip Erdogan University Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 22, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 3, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 3, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RecepTayyip ErdoganUniversity

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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