NCT07287540

Brief Summary

This study aimed to determine the effect of anti-inflammatory nutrition on non-surgical periodontal treatment in individuals with periodontitis by evaluating gingival crevicular fluid (GCF) and serum biomarkers and clinical periodontal parameters. A total of 100 volunteers identified as having a pro-inflammatory diet (Q3 and Q4) will be included in the study. Individuals will be assigned to two groups. These groups will then be further divided into two groups based on whether or not they will receive anti-inflammatory nutrition education. Group Q3-1 (n=25) will receive non-surgical periodontal treatment and anti-inflammatory nutrition education. Group Q3-2 (n=25) will receive only non-surgical periodontal treatment. Group Q4-1 (n=25) will receive non-surgical periodontal treatment and anti-inflammatory nutrition education. Group Q4-2 (n=25) will receive only non-surgical periodontal treatment. After the periodontal index measurements are completed, the patients will receive non-surgical periodontal treatment. GCF and serum samples, periodontal clinical parameters and Dietary Inflammatory Index will be collected 3 times: at baseline, 1.5 and 3 months after non-surgical periodontal treatment. Levels of interleukin (IL)-1β, IL-10, tumor necrosis factor (TNF)-α, total oxidant status (TOS), total antioxidant status (TAS), and C-reactive protein (CRP) will be assessed from these samples. This will investigate the role of anti-inflammatory nutrition in reducing periodontal inflammation and increasing treatment success.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-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
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 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

periodontitisdiet inflammatory indexanti-inflammatory nutrition

Outcome Measures

Primary Outcomes (2)

  • periodontal pocket depth

    It will be calculated by measuring the distance between the gingival margin 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, after nonsurgical periodontal treatment at 1.5 months, after nonsurgical periodontal treatment at 3 months.

  • 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, after nonsurgical periodontal treatment at 1.5 months, after nonsurgical periodontal treatment at 3 months.

Secondary Outcomes (6)

  • interleukin (IL)-1β level

    baseline, after nonsurgical periodontal treatment at 1.5 months, after nonsurgical periodontal treatment at 3 months.

  • interleukin (IL)-10 level

    baseline, after nonsurgical periodontal treatment at 1.5 months, after nonsurgical periodontal treatment at 3 months.

  • tumor necrosis factor (TNF)-α level

    baseline, after nonsurgical periodontal treatment at 1.5 months, after nonsurgical periodontal treatment at 3 months.

  • serum total oxidant status (TOS) level

    baseline, after nonsurgical periodontal treatment at 1.5 months, after nonsurgical periodontal treatment at 3 months.

  • serum total antioxidant status (TAS) level

    baseline, after nonsurgical periodontal treatment at 1.5 months, after nonsurgical periodontal treatment at 3 months.

  • +1 more secondary outcomes

Study Arms (4)

Q3-1: Nonsurgical periodontal treatment and anti-inflammatory nutrition education

Other: non surgical periodontal trearmentOther: anti-inflammatory nutrition education

Q3-2: Only nonsurgical periodontal treatment

Other: non surgical periodontal trearment

Q4-1: Nonsurgical periodontal treatment and anti-inflammatory nutrition education

Other: non surgical periodontal trearmentOther: anti-inflammatory nutrition education

Q4-2: Only nonsurgical periodontal treatment

Other: non surgical periodontal trearment

Interventions

Participants in Groups Q3-1 and Q4-1 will receive anti-inflammatory nutrition education

Q3-1: Nonsurgical periodontal treatment and anti-inflammatory nutrition educationQ4-1: Nonsurgical periodontal treatment and anti-inflammatory nutrition education

All participants will receive nonsurgical periodontal treatment

Q3-1: Nonsurgical periodontal treatment and anti-inflammatory nutrition educationQ3-2: Only nonsurgical periodontal treatmentQ4-1: Nonsurgical periodontal treatment and anti-inflammatory nutrition educationQ4-2: Only nonsurgical periodontal treatment

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study included individuals who applied to Recep Tayyip Erdogan University, Faculty of Dentistry, Department of Periodontology for treatment

You may qualify if:

  • Being systemically healthy
  • Not smoking
  • Not using anti-inflammatory drugs in the last 3 months, antibiotics, or systemic corticosteroids in the last 6 months
  • Not being pregnant or lactating
  • Not having received periodontal treatment in the last 6 months
  • Having at least 20 teeth in the mouth
  • Being diagnosed with periodontitis by the investigator
  • Having a dietary inflammatory index \>0

You may not qualify if:

  • Having a systemic disease
  • Smoking
  • Using anti-inflammatory drugs within the last 3 months, antibiotics within the last 6 months, or systemic corticosteroids
  • Being pregnant or lactating
  • Having received periodontal treatment within the last 6 months
  • Having fewer than 20 teeth in the mouth
  • No periodontitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Recep Tayyip Erdoğan University

Rize, 53020, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

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

April 1, 2026

Last Updated

December 17, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations