NCT07287553

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

November 22, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 17, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2026

Completed
Last Updated

December 17, 2025

Status Verified

November 1, 2025

Enrollment Period

3 months

First QC Date

November 17, 2025

Last Update Submit

December 3, 2025

Conditions

Keywords

obesityperiodontal statusdietary inflammatory index

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    baseline

Secondary Outcomes (10)

  • interleukin (IL)-1β level

    baseline

  • interleukin (IL)-10 level

    baseline

  • total oxidant status (TOS) level

    baseline

  • total antioxidant status (TAS) level

    baseline

  • serum leptin level

    baseline

  • +5 more secondary outcomes

Study Arms (4)

anti-inflammatory diet group 1

Individuals on an anti-inflammatory diet

Other: Periodontal indices will be obtainedOther: serum and crevicular fluid samples will be collected

anti-inflammatory diet group 2

Individuals on an anti-inflammatory diet

Other: Periodontal indices will be obtainedOther: serum and crevicular fluid samples will be collected

pro-inflammatory diet group 1

individuals on a pro-inflammatory diet

Other: Periodontal indices will be obtainedOther: serum and crevicular fluid samples will be collected

pro-inflammatory diet group 2

individuals on a pro-inflammatory diet

Other: Periodontal indices will be obtainedOther: serum and crevicular fluid samples will be collected

Interventions

Periodontal indices will be obtained from all participants

anti-inflammatory diet group 1anti-inflammatory diet group 2pro-inflammatory diet group 1pro-inflammatory diet group 2

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

anti-inflammatory diet group 1anti-inflammatory diet group 2pro-inflammatory diet group 1pro-inflammatory diet group 2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Recep Tayyip Erdoğan University

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Recep Tayyip Erdoğan University

Rize, 53020, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Hatice Yemenoglu

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

November 17, 2025

First Posted

December 17, 2025

Study Start

November 22, 2025

Primary Completion

February 21, 2026

Study Completion

March 21, 2026

Last Updated

December 17, 2025

Record last verified: 2025-11

Locations