- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07287553
Dietary Inflammatory Index and Periodontal Status in Obese Patients
December 3, 2025 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
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
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
- Name: Hatice Yemenoglu
- Phone Number: +905052977517
- Email: htcymnglu@hotmail.com
Study Locations
-
-
-
Rize, Turkey (Türkiye), 53020
- Recruiting
- Recep Tayyip Erdogan University
-
Contact:
- Hatice Yemenoglu
- Phone Number: +904642220000
- Email: htcymnglu@hotmail.com
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
anti-inflammatory diet group 1
Individuals on an anti-inflammatory diet
|
Periodontal indices will be obtained from all participants
Serum and gingival crevicular fluid samples will be collected from all participants.
|
|
anti-inflammatory diet group 2
Individuals on an anti-inflammatory diet
|
Periodontal indices will be obtained from all participants
Serum and gingival crevicular fluid samples will be collected from all participants.
|
|
pro-inflammatory diet group 1
individuals on a pro-inflammatory diet
|
Periodontal indices will be obtained from all participants
Serum and gingival crevicular fluid samples will be collected from all participants.
|
|
pro-inflammatory diet group 2
individuals on a pro-inflammatory diet
|
Periodontal indices will be obtained from all participants
Serum and gingival crevicular fluid samples will be collected from all participants.
|
What is the study measuring?
Primary Outcome Measures
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
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.
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)
November 22, 2025
Primary Completion (Estimated)
February 21, 2026
Study Completion (Estimated)
March 21, 2026
Study Registration Dates
First Submitted
November 17, 2025
First Submitted That Met QC Criteria
December 3, 2025
First Posted (Actual)
December 17, 2025
Study Record Updates
Last Update Posted (Actual)
December 17, 2025
Last Update Submitted That Met QC Criteria
December 3, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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