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NCT Number: NCT07287553

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Recep Tayyip Erdoğan University

Rize, 53020, Turkey (Türkiye)

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Periodontal indices will be obtained

Other

Periodontal indices will be obtained from all participants

serum and crevicular fluid samples will be collected

Other

Serum and gingival crevicular fluid samples will be collected from all participants.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. interleukin (IL)-1β level

    Time frame: baseline

    IL-1β levels will be measured with biochemical kits.

  2. interleukin (IL)-10 level

    Time frame: baseline

    IL-10 levels will be measured with biochemical kits.

  3. total oxidant status (TOS) level

    Time frame: baseline

    TOS levels will be measured with biochemical kits.

  4. total antioxidant status (TAS) level

    Time frame: baseline

    TAS levels will be measured with biochemical kits.

  5. serum leptin level

    Time frame: baseline

    Leptin levels in serum will be measured with biochemical kits.

  6. serum tumor necrosis factor (TNF)-α level

    Time frame: baseline

    TNF-α levels in serum will be measured with biochemical kits.

  7. serum adiponectin level

    Time frame: baseline

    Adiponectin levels in serum will be measured with biochemical kits.

  8. serum C-reactive protein (CRP) level

    Time frame: baseline

    CRP levels in serum will be measured with biochemical kits.

  9. serum malondialdehyde (MDA) level

    Time frame: baseline

    MDA levels in serum will be measured with biochemical kits.

  10. serum glutathione (GSH) level

    Time frame: baseline

    GSH levels in serum will be measured with biochemical kits.

Sponsors and collaborators

Lead sponsor

Recep Tayyip Erdogan University Training and Research Hospital

Other

Registry information

Official study title

The Relationship Between Dietary Inflammatory Index and Periodontal Status in Obese Patients

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 17, 2025
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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